Approved prescription drug products with therapeutic equivalenceevaluations.[Washington, D.C.?] : U.S. Dept. of Health and Human Services, Public Health Service,Food and Drug Administration, Bureau of Drugs : 1980-

http://hdl.handle.net/2027/mdp.39015072932893

Public Domain, Google-digitizedhttp://www.hathitrust.org/access_use#pd-google

We have determined this work to be in the public domain,meaning that it is not subject to copyright. Users arefree to copy, use, and redistribute the work in part orin whole. It is possible that current copyright holders,heirs or the estate of the authors of individual portionsof the work, such as illustrations or photographs, assertcopyrights over these portions. Depending on the natureof subsequent use that is made, additional rights mayneed to be obtained independently of anything we canaddress. The digital images and OCR of this work wereproduced by Google, Inc. (indicated by a watermarkon each page in the PageTurner). Google requests thatthe images and OCR not be re-hosted, redistributedor used commercially. The images are provided foreducational, scholarly, non-commercial purposes.

SERIAL

\OIUEINV

:IOSBLVLS

0311M‘

3H1A803180530

@961

I»I Am:

.The L,'ni"é"¢~>;'3;;7,vof MichiganPharmacyLibrary

flAPPROVED

WITH

4T" EDITION;

SBIHVHBI'I

NVEJIHOIWJOMINI-LIN"

US. DEPARTMENT OF HEALTH AND HUMAN SERVICESPUBLIC HEALTH SERVICE

FOOD AND DRUG ADMINISTRATIONNATIONAL CENTER FOR DRUGS AND BIOLOGICS

CUMULATIVESUPPLEMENT 1

AUG ‘83 - s|-:|> ‘as

PRESCRIPTIONDRUG PRODUCTSTHERAPEUTIC EQUIVALENCE EVALUATIONS

m»?.1115UN|VER‘OF.MICK-Hafiz’!

NOV 21 1983PHARMAC?‘“BEAR!

3fl'

/ Wnc/5%

‘K?

Y‘

Y

FOOD

AND

DRUG

ADMINISTRATION

APPROVED

PRESCRiFTION

DRUG

PRODUCTS

ITH

THERAPEUTIC

EQUIVALENCE

EVALUATIONS

CUMULATIVE

SUPPLEMENT

I.PREFACE

This

cumulative

supplement

isone

of

a

series

ofmonthly

updates

tothe

Approved

Prescription

Drug

Products

with

Therapeutic

Equivalence

Evaluations,

ithEdition,

(the

List)

tocover

interim

revisions

tothe

annual

publication

ofthe

List

inits

entirety.

The

List

iscomprised

ofseveral

parts

and

some

bytheir

nature

are

identified

bythe

term

"list".

The

cumulative

supplements

routinely

provide

updates

totwo

ofthese

lists:

The

Drug

Product

List

and

the

DESI

Addendum.

The

List

cannot

beused

effectively

without

the

current

cumulative

supplement.

Users

may

wish

toplace

anasterisk

(*)

inthe

List

tothe

left

ofthe

ingredient(s)

inthe

Drug

Product

List

and

the

product

name

inthe

Addendum

toindicate

that

changes

tothat

entry

appear

inthe

cumulative

supplement.

Itis

also

suggested

that

earlier

cumulative

supplements

be

discarded

toavoid

possible

confusion.

Inthis

way,

only

the

List

and

current

cumulative

supplement

need

bereferenced.

A.DRUG

PRODUCT

LIST

The

Drug

Product

List

cumulative

supplements

include

the

changes

made

since

August

l,

l983.

Each

subsequent

cumulative

supplement

replaces

the

previous

month's

cumulative

supplement.

Information

inthis

cumulative

supplement

follows

the

format

ofthe

Drug

Product

List.

The

presence

ofany

therapeutic

equivalence

code

indicates

that

the

drug

product

ismultisource;

the

deletion

of

a

therapeutic

equivalence

code

indicates

that

the

drug

product

has

become

single

source.

(An

infrequent

exception

exists

when

atherapeutic

equivalence

code

isrevised.

Inthat

case

the

deletion

ofthe

therapeutic

equivalence

code

isfollowed

immediately

bythe

addition

ofthe

revised

one.)

Context

information

ondrug

products

isprovided

ineach

cumulative

supplement

for

completeness

toassist

inlocating

the

proper

place

inthe

Drug

Product

List

for

the

revision.

(Strength(s)

which

already

exist

inthe

publication

will

not

berepeated

for

context.)

A

page

number

inparentheses

referring

tothe

Drug

Product

List

islocated

tothe

right

ofthe

ingredient(s).

Additions

tothe

Drug

Product

List

are

indicated

bynew

information

inthe

cumulative

supplement.

Additions

new

tothe

current

cumulative

supplement

are

indicated

bythe

symbol

>ADD>'

tothe

left

ofthe

line

onwhich

new

information

exists.

The

>Jm2_>symbol

isdropped

insubsequent

cumulative

supplements

for

that

item.

Deletions

fromtheDrugProduct

List

areindicated

byoverstruck

printin

thecumulative

supplement.

Deletions

newtothecurrent

cumulative

supplement

areindicated

bythesymbolZLHL->

(DELETE)

totheleftofthe

line

containing

theoverstruck

print.

The>IHI->

symbolisdroppedin

subsequent

cumulative

supplements

forthat

item.

A

newly

approved

productisidentified

by

thelozenge(I)totherightof

itsstrength.

This

identifier

remains

throughout

allcumulative

supplements

forthis

edition.

ADDENDUM:

DESIPending

List

Information

inthis

cumulative

supplement

follows

theformatofthe

Addendum.

Additions

anddeletions

areindicated

inthesamemannerasin

thecumulative

supplement

totheDrugProduct

List.

A

changeinCurrent

Statusof

a

DESIproductisalso

indicated

byanaddition

and

a

deletion.

II.SPECIAL

NOTES

REPORT

OFCOUNTS

FORTHEDRUGPRODUCTLIST

Categories

ofcounts

derived

from

product

information

intheDrugProduct

List

andfromthis

cumulative

supplement

arepresented.

Thereport

includes

countsofnewmolecular

entities

approved

bytheagency

during

thecurrent

month.

SUBSCRIPTION

FORM

Asubscription

form

forthepublication

hasbeen

provided

attheendof

this

supplement

foruseinobtaining

additional

subscriptions.

ii

III. REPORT OF COUNTS FOR THE DRUG PRODUCT LISTDESCRIPTION OF REPORT

The following report provides summary counts derived from product information in the Drug Product List and thecurrent cumulative supplement. The counts appear in two sections. Section A. refers to the products in theList and Section B. to products in the current cumulative supplement. A new column of data will appear inSection A. each three-month period following July '83. Section A. therefore will provide baseline and quarterlydata while Section B. provides monthly activity.USE OF REPORT

From the data presented under Section 8., users should be able to observe such things as (l) newly approved,DESI effective and remarketed drug products which are added to the List; (2) products that are being removedfrom the List as the result of withdrawal of approval, changes from prescription to over-the-counter status anddiscontinued marketing of products; and, (3) trends in approval of products as either multisource or singlesource during each month within the quarter. The report does not reflect category changes from multisource tosingle source and vice versa. However, the net gain that results from all additions, deletions and categorychanges is reflected in the quarterly counts for multisource and single source products.

Drug Product Definition

For this report, a drug product is the representation in the Drug Product List of an active moiety (includesmolecular entity and its salts, esters and derivatives) either as a single entity or as a combinationproduct, provided in a specific dosage form and strength for a given route of administration marketed by afirm under a particular generic or trade name.

New Molecular Entity

The active moiety has not previously been approved (either as the parent compound or as a salt, ester orderivative of the parent compound) in the United States for use in a drug product either as a singleingredient or part of a combination.

Drug Product Count

This report provides counts in several categories from the list composed of domestically marketed drugproducts approved for both safety and effectiveness under sections 505 and 507 of the Federal Food, Drug,and Cosmetic Act. Counts of products still pending in the DESI review are not provided. Excluded also arethose approved drug products marketed by distributors; those marketed solely abroad; and products nowregarded as medical devices, biologics or foods. Also not included in the counts are those duplicateproducts of a given applicant whose only distinguishing characteristics are items such as package size,inactive ingredient(s), color and alternate manufacturing sites. These various counts are excluded becausethe Drug Product List itself excludes products from these categories.

REPORTOFCOUNTSFORTHEDRUGPRODUCTLIST

A.COUNTSCUMULATIVEBYQUARTERS

CATEGORIESCOUNTEDJULY'83(BASELINE)

DRUGPRODUCTSLISTED6679SINGLESOURCE1908(28.6%)

MULTISOURCE(I)477|(7|.41)THERAPEUTICALLYEQUIVALENT3804(57.0%)

NOTTHERAPEUTICALLYEQUIVALENT957

APPROVED PRESCRIPTION DRUG PRODUCTS 1DRUG PRODUCT LIST

CUMULATIVE SUPPLEMENT NUMBER 1 / AUGUSTAMINOPHYLLINE (PAGE 3-8)

> OLT > /£i§fii¢§/DPA£/> ADD > SOLUTION; ORAL> AOO > AMINOPHYLLINE> AOO > A_ ROXANE LABORATORIES LOSUS-SULU

TABLET; ORALAMINOPHYLLINE

> ADD > 80 BARR LABORATORIES looms:> ADD > 80 zoonen

> ADD > ASPIRIN; BUTALBITAL; CAFFEINE (PAGE 3—15)

> TABLET; ORAL> ADD > ASPIRIN AND CAFFEINE W/ BUTALBITAL

> PUREPAC/KALIPHARMA 325MG;50MG;40MG!

ASPIRIN; BUTALBITAL; CAFFEINE; PHENACETIN (PAGE 3-15)TABLET; ORAL.P.°. WI BUTALBITAL

> on MY fiapazammiapxm/ mmssmaimamma/> ADD > ASPIRIN; CAFFEINE; DIHYDROCODEINE BITARTRATE (PAGE 3-15)

V > UV D DV > U IE

HG

V > U

> ADD > CAPSULE; ORAL

> ADD > SYNALGOS-DC

> ADD > IVES LABS/AMHO 356.4MG;30MG;16MGI

ASPIRIN; CAFFEINE; PHENACETIN; PROPOXYPHENE HYDROCHLORIDE(PAGE 3-15)

CAPSULE; ORALPROPOXYPHENE counounn 65

> OLT >/AA , - , L éffléiiéldfidiidédéiéfiflé/

> OLT > lééfird'ddfiéddfld'éé

> DLT > ,LABS/lééifldiéélddéiiéifldiééfié/

U

46 r . .> LT >/_—/ /§K£é$'édfi¢ddfld

> OLT >/é§/ ,L ,ORIES/ lééffiéfiéldfléii6éfléié$flél

ASPIRIN; CAFFEINE; PROPOXYPHENE HYDROCHLORIDE (PAGE 3-16)

CAPSULE; ORALDARVON COMPOUND-65

> ADD > AA ELI LILLY INDSTRS-PR 389MG;52.¢MG;65MG

> ADD > SK—65 COMPOUND

> ADD > A_ SK&F LABORATORIES 389MG;52.4MG;65MGI

V ]> U VVVVV

13

V 3) U UV D O O

V b O OVVVVV

13ENG

V > U U

V > O O

V > U U V 15

V > U U

V > U UVVVVVV > U U ISIS

V > U U

V > U U 15

V > U U V 13

'83 & SEPTEMBER '63

ASPIRIN; QARISOPRODQL (PAGE 3-16)TABLET; ORALSOMA COMPOUNDWALLACE PHARMS/C-W 3ZSMG;ZOOMG!

ASPIRINI,CARISOPRODOLifCODEINE PHOSPHATE (PAGE 3-16)

TABLET; ORALSOMA COMPOUND W/ CODEINEWALLACE PHARMS/C-W 325MG;200MG;16MG!

ASPIRIN; HYDROCODONE BITARTRATE (PAGE 3-16)

TABLET; ORALVICODINKNOLL PHARMACEUTICAL 500MG;5MG!

BACAMPICILLIN HYDROCHLORIDE (PAGE 3-18)TABLET; ORALSPECTROBIDPFIZER LABS-PFIZER BOOMG!

BETAMETHASONE VALERATE (PAGE 3-21)

CREAM; TOPICALBETAMETHASONE VALERATE

E FOUGERA/BYK—GLDN EQ 0.12 BASE!PHARMADERM/BYK-GLDN EQ 0.12 BASE!QEIAIKE!SAVAGE LABS/BYK-GLDN EQ 0.12 BASE!

LOTION; TOPICALBETAMETHASONE VALERATE

E FOUGERA/BYK-GLDN EQ 0.12 BASE!PHARMADERM/BYK—GLDN EQ 0.12 BASE!QEIAIEEKSAVAGE LABS/BYK—GLDN EQ 0.12 BASE!EALZ§£§§SCHERING EQ 0.12 BASE

OINTMENT; TOPICALBETAMETHASONE VALERATE

E FOUGERA/BYK-GLDN :9 0.12 BASE!PHARHADERM/BYK-GLDN EQ 0.12 EASEUQEIAIEE!SAVAGE LABS/BYK-GLDN Eg 0.1z BASE!URLESQUESCHERING EQ_QELZ_EA§E

DRUGPRODUCTLIST/CUMULATIVESUPPLEMENTNUMBER1/AUGUST'83&SEPTEMBER'83BUPIVACAINEHYDROCHLORIDE;EPINEPHRINEBITARTRATE(PAGE3-23)

INJECTABLE;INJECTIONMAROAIHEHOLNIEPINEPHRINE

>ADD>A!BREONLABS-STERLING0.52;0.0091MG/ML>ADD>A!0.752;0.0091MG/ML>ADD>SEHSOROAIHE>ADD>A!ASTRAHOSPPHARM0.52;0.0091MG/ML!>ADD>A!0.752;0.0091MG/ML!

>OLT>/OA¢¢E1HE§'OAR£§6RROOOE§'dddéiflé'ifldéifléfég‘RHEHAOEfiN/(PAGE3'24)

>w>lffiéifis'fdéfii/ >>TIA'I-‘OIIPDTINR'II.'A15/>II;>ISIAAIWA'AAARQSAIIIAAM:AAAAAOAAARAAAA/

CAFFEINE;CARISOPRODOL;PHENACETIN(PAGE3-25)

TABLET;ORAL

>DLT>/SOHA'OOHROUNO>OLT>/é§/LLRfl$/¢§fl/liéfiéiiddfiéiiédflé/

CALCIUMCHLORIDE‘DEXTROSE‘MAGNESIUMCHLORIDE’SODIUMACETATE‘SODIUMCHLORIDE(PAGE3-26)

SOLUTION;INTRAPERITONEAL

)ADD>DIALYTECONCENTRATEW/DEXTROSE302INPLASTICCONTAINER

>ADD>AMMCGAN/AMHOSP510MG/100ML;3OGM/100ML;

>ADO>200MG/100ML;9.ZGM/100ML;

>ADD>.9.6GM/100ML!

>ADD>510MG/100ML;3OGM/100ML;

>ADD>200MG/100ML;9.4GM/100ML;

>ADD>IIGM/IOOML!

>ADO>DIALYTECONCENTRATEW/DEXTROSE502INPLASTICCONTAINER

>ADD>AMMCGAN/AMHOSP510MG/100ML;5°GM/100ML

>ADD>200MG/100ML;9.ZGM/100ML;

>ADD>9.66M/100ML!

>ADD>510MG/100ML;5°GM/100ML;

>ADD>200MG/100ML;9.4GM/100ML;

>ADD>IIGMIIOOML!

>ADD>CEFTIZOXIMESODIUM(PAGE3-30)

>ADD>INJECTABLE;INJECTION

>ADD>CEFIZOX

>ADD>SK&FLABORATORIESEQIGMBASE-VIAL!

>ADD>EQ26MBASE-VIAL!

CHLORDIAZEPOXIDE(PAGE3-33)

VV>>COCOVVV

CAPSULE;CONTROLLEDRELEASE;ORALLIBRELEASE

HOFFMANN-LAROCHE30MB! V>UU

CHLOROTHIAZIDE(PAGE3-35)

TABLET;ORALCHLOROTHIAZIDE

CHELSEALABORATORIES250MB!500MB!

V>OO

V>UUVVISIS

CHLORPHENIRAMINEMALEATE(PAGE3-36)

TABLET;ORALCHLORPHENIRAMINEMALEATE

>__DLT>/4_4/..L

CHLORTHALIDONE(PAGE3-38)

TABLET;ORALQHLQBIUALIDQEE

>ADD>APUREPAC/KALIPHARMA50MB!

CHLORZOXAZONE(PAGE3-39)

TABLET;ORALCHLORZOXAZONE

>ADD>APARPHARMACEUTICAL250MG!

CYANOCOBALAMIN(PAGE3-44)

INJECTABLE;INJECTIONREDISOL

MS-D-MERCKSYTOBEXPARKEDAVIS/N-L

>DLT>/é£/

>OLT>/ég/

ldIiHé/Hfi

ldlifié-hfl/

DESOXIMETASONE(PAGE3-49)

OINTMENT;TOPICALTOPICORT

HOECHST-ROUSSEL0.252!

V A OV > U

V > UVVV > U

V UFqV >UU

VVVVVVVV

V > U U

V > U U

V > U U

V A D U

V A U D

V > U U

DRUG PRODUCT LIST / CUMULATIVE SUPPLEMENT NUMBER 1 / AUGUST '83 & SEPTEMBER '83

DEXAMETHASONE (PAGE 3-49)

SOLUTION; ORALDEXAMETHASONEROXANE LABORATORIES 0.5MG/5ML!DEXAMETHASONE INTENSOLROXANE LABORATORIES 0.5MG/0.5ML!

TABLET; ORALDECADRON

> ADD > BP MS-D-MERCK 6M6DEXAMETHASONE

BP ROXANE LABORATORIES 6M6!1M6!

DEXAMETHASONE SODIUM PHOSPHATE (PAGE 3-50)INJECTABLE; INJECTION/HERAOROL'RHOS¢HATE/HEXADROL

AG ORGANONIAKZONA EQ 6M6 PHOSPHATE-MLEQ zone PHOSPHATE-ML

DEXTROSE; DOPAMINE HYDROCHLORIDE (PAGE 3-53)

INJECTABLE; INJECTION I

/D¢PAHIN£.H¢L.1N.P¢XIR¢$£.$2/DOPAMINE HOLABBOTT LABORATORIES 5OM/100ML280MS/100ML

SGH/100ML;160HG/100HLDOPAHINE HOL IN RLASTIO CONTAINERABBOTT LABORATORIES SGH/100HL;80MG/500HLI

SGM/IOOHL3160MG/100HL!56M/100ML;320M6/100ML!

ISISISIS

DIETHYLPROPION HYDROCHLORIDE (PAGE 3-59)TABLET; ORALDIETHYLPROPION "BL

55 CAMALL 25MB!

DIPHENHYDRAMINE HYDROCHLORIDE (PAGE 3-61)

CAPSULE; ORALSK-DIPHEHHYDRAMINE

> OLT >léé/ SK&F LABORATORIES lééfié/

L

> on > /SK-‘OIRTIETITHIIRATIITIE>_Di>/é.é/ .J- . S/ liélériélémll

V > UVVV > U

V > U

V > U

V > U VVV

V > OVVVV > U

V > U

V ) - V

V > U

V - UV > U

V > U VVVV

V > U U

V A O U

V > U U

V > U U

V A D U

V > O U

V > U U

V )5 D OVVVVVVVVVVVVV

ELIXIR; ORA V > U U

V p - UV > U U

V > U U

v > D C

DISULFIRAM (PAGE 3-63)

TABLET; ORALDISULFIRAM

BX CHELSEA LABORATORIES ZSOMG!BX SOOMG!

DOXYCYCLINE HYCLATE (PAGE 3-64)CAPSULE; ORALDOXYOYOLIHE HYCLATE

AB CHELSEA LABORATORIES EQ 50MB BASE

EPINEPHRINE; LIDOCAINE HYDROCHLORIDE (PAGE 3-66)

INJECTABLE; INJECTIONLIDOCATON

AG PHARMATON-SZ 0.01us/mlzgguAG o.ozualnl:ggu

ERYTHROMYCIN (PAGE 3-67)

OINTMENT; OPHTHALMICERYTHROHYOIH

A; E FOUGERA/BYK-GLDN sue-sunA; PHARHADERM/BYK-GLDN BUS-SUNILOTYCIN

A; OISTA PRODS-LILLY Sggggg

SENTAHICIN SULFATE (PAGE 3-79)

CREAM TOPICALGEHTAFAIR

AI PHARMAFAIR EQ_IHE_QA§E£EHPGEHTAHIOIH SULFATE

A; NMC LABORATORIES §g_;g§_BA§§4§gnINJECTABLE; INJECTIONGENTAHIOIN SULFATE

AG . ABBOTT LABORATORIES :9 sons BASE/JOOMLAAG EQ 70MB BASEIOOHL!93 E sows BASEIIOOMLIA! EQ 9056 BASE/IODML!QB EQ IOCHG BASEIIODML!5! Eg 1.2MG BASE-ML!A! EQ 1.4MG BASE-ML!AG EQ 1.6MG BASE-ML!QB EQ 1.8HS BASE-ML!AG 59 2B3 BASE-NLU53 E 10MB BASE-ML!AG EQ Q HG BASE-ML!QB LYPHO-MED EQ QOHG BASE-ML!

DRUGPRODUCTLIST/CUMULATIVESUPPLEMENTNUMBER1/AUGUST‘83&SEPTEMBER'834GENTAMICINSULFATE(PAGE3-79)

INJECTABLE;INJECTION>ADD>GENTAMICINSULFATEINPLASTICCONTAINER>ADD>A!ABBOTTLABORATORIESEQ60MBBASEIIOOML!>ADD>A!EQ70MBBASE/IDOHL!>ADD>ABEQ80MBBASE/IDOHL!>ADD)A!EQ90MBBASE/IDOHL!>ADD>5!Eg100MBBASEIIOOML!>ADD>A!EQ1.2MGBASE-ML!>ADD>A!EQ1.4MGBASE-ML!>ADD>A!EQ1.6MGBASE-ML!>ADD)A!EQI.8HGBASE-ML!>ADD>A!EQ2M6BASE-ML!

ISOTONICGENTAMICINSULFATEINPLASTICCONTAINER>ADD>A!TRAVENOLLABSEQ0.8MGBASE-ML!)ADD>A!EQ80MBBASEIIUOML!

I'iGONADOTROPINCHORIONIC(PAGE3-81)

INJECTABLE;'INJECTIONRINS>DLT>/INTUIT/>OLT>/é£/

;'ISIHEI/lSiddd'UHifSlVidi/

HOMATROPINEMETHYLBROMIDE(PAGE3-86)

TABLET;ORALHOMAPIN-IO

>DLT>léé/MISSIONPHARMACAL10MB>DLT>/SEOS-TENSSE>OLT>/é§/Llidfid/

HYDRALAZINEHYDROCHLORIDE(PAGE3-86)

TABLET;ORALHYDRALAZINEHOL

>AOO>55PARPHARMACEUTICAL100MB!>AOO>AGPUREPAC/KALIPHARMAsome:

HYDROCHLOROTHIAZIDE;SPIRONOLACTONE(PAGE3-89)

TABLET;ORALSPIRONOLACTONERIHYDROOHLOROTHIAZIUE

>ADD>ABPUREPAC/QUALIPHARMAzsuszzsnsn

HYDROCORTISONE(RASE3-90)

CREAM;TOPICALNYOROOORTISONE

>ADD>51BAYLABORATORIES13!>AOO>AT2.52:

HYDROCORTISONE(PAGE3-90)

LOTION;TOPICAL>OLT>/OELAOORT

>_QL1_>/éi/‘7HEPIEBNI1NRRSIRIES/

léiéi/HYDROCCRTISONE

>ADD>ATMERICONINDUSTRIES0.52>_QLI_>31/lfflflNEIPAUiSEN//§Z§Z/

OINTMENT;TOPICALEIQBQQQBIIEQNE

>ADD>51BAYLABORATORIES1;:>Ann>A_2.52:

>OLTlupin/lfiléfi/

HYDROCORTISONE;NEOMYCINSULFATE;POLYMYXINBSULFATE(PAGE3-92)

SOLUTION/DROPS;.OTIC>AOO>NEO-OTOSOL—HC>ADD>ALCARTER-GLOGAULABSIG-EG5.5MGBASElHL;10;000UNITS-ML!

HYDROCORTISONEACETATE(PAGE3-93)

CREAM;TOPICALHYDROCORTISONEACETATE

>_2LI_>/éI/733RAEYFZU£33R7lizlLOTION;TOPICALORIOORT

>DLT>/é1/INGRAMPHARM’0.52>OLT>lfifdRdddRfISdNEAdEfAfE

I >___w>/At/7.?BIINEfPZIiI-‘3EN714>OLT>ISUSPENSIRN/RRRP$5ZRPHIHAIHI¢JIRII¢I>OLT>lHXRRRCdRIdNE/

, >BLT>/HSAR-HKR-K//¢.$2/

UIQEQQQBII§QNE_MALEBAIE(PAGE3'95)

>AOO>OINTMENT;TOPICAL>AOO>NEsTcoRT>ADD>NESTNOOOPHARMS0.22:

UYOROXYZINEHYOROORLORIOE(PAGE3-96)

TABLET;ORALHYDROXYZINEHOL

>AOO>ABDANBURYPHARMACAL10MB!>ADD>AB25MB!>Ann>ABErma"

DRUG PRODUCT LIST / CUMULATIVE SUPPLEMENT NUMBER 1 / AUGUST '83 & SEPTEMBER '83HYDROXYZINE PAMOATE (PAGE 3-96)

CAPSULE; ORALHYDROXYZINE PAMOATE

> ADD > 5Q VANGARD LABS-MN" EQ ZSHG HOLN> ADD > 99 E9 SONG HcLu

IMIPRAMINE HYDROCHLORIDE (PAGE 3-97)

‘AREAS> DLT > , ,> BLT > LBP/ /L-NN-N/ /25N¢/> on U“ HAMMERING MM> OLT >

33/ ,

>AL>/_/ /_1/ISOETHARINE HYDROCHLORIDE (PAGE 3-100)

SOLUTION; INHALATIONISOETHARIHE HOL

> ADD > A! INTL MEDICATION SYS 0.1672

> ADD > 95 ROXANE LABORATORIES 0.1672!

> ADD > 95 TRAVENOL LABS 0.252!

KANAMYCIN SULFATE (PAGE 3-102)

INJECTABLE; INJECTION

> ADD > KANAHYOIN SULFATE

> ADD > INTL MEDICATION SYS EQ 500MB BASE-2ML!

> ADD > EQ IGH BASEISHLH

V U r q

.1 } ‘.I‘IIZ/liéfilzfilf

BRISTOL LABS/B-M EQ 75HG BASEIZHLEQ 500MB BASEIZML

E 16" BASEISML

KANTREX "' I

A

I

—7BRI§I¢L.Lfi¢$/BrH/;g%3%:fiNL/

V P U U

V > U U

V

VV

>DO

Ur-r

o4-4

v

v“<&&

|>I>|>|ij\>~

|>|>

11"

‘U~'U.

LIDOCAINE HYDROCHLORIDE (PAGE 3-104)

INJECTABLE; INJECTIONLIOOOATON

_g PHARMATON-SZ gguVV >) CO CO VV 9

METHYLTESTOSTERONE (PAGE 3-121)

TABLET; BUCCAL-SUBLINGUALMETHYLTESTOSTERONE

> OLT > LBP/ LIDNNEXPADLSEN/ lififié/

METRONIDAZOLE (PAGE 3-122)

INJECTABLE; INJECTION

> ADD > METRO I.V. IN PLASTIC CONTAINER> ADD > A! AM MCGAN/AM HOSP SOOHG/lOOML!

TABLET; ORALDEIBQEIQAZQLE

> ADD > AB PAR PHARMACEUTICAL 250MB!

> ADD > AB SONG!

> ADD > NANDROLONE DECANOATE (PAGE 3-125)

> ADD > INJECTABLE; INJECTION

> ADD > NANDROLONE DECANOATE

> ADD > MAURRY BIOLOGICAL IOOMG/ML!

NITROGLYCERIN (PAGE 3-128)

INJECTABLE; INJECTION> ADD > HITRONAL

> ADD > A! G POHL-BOSKAMP ENG-ML!

> ADD > IMG-ML!TRIDIL

> ADD > AM CRITICAL CARE-AHS O.5MG/ML!

OXTRIPHYLLINE (PAGE 3-131)

TABLET, ENTERIC COATED; ORALCHOLEDYL

> ADD > AB PARKE-DAVIS/N—L IOOMG

> ADD > AB 200MB

> ADD > OXTRIPHYLLINE

> ADD > AB BOLAR PHARMACEUTICAL 100MB!

> ADD > AB 200MB!

OXYTETRACYCLINE HYDROCHLORIDE (PAGE 3-132)

CAPSULE; ORAL

> OLT > /OREOPAR>_Qll_>/é§/ A PDAVIS/NFI/ léfiléééfié'édéél

PENICILLIN V POTASSIUM (PAGE 3-135)

PONDER FOR RECONSTITUTION; ORAL> DLT > /UIIOILLIN'VK

> DLT > AA YflFJBHI? Ed'flééfié'dAsE/SNL/

> DLT >I§ZI

I

IEOAB fiéfEAELIS Ll

M‘P'fi/ ISIIIIYIITL'NYIIXIII lflfl/

DRUG PRODUCT LIST / CUMULATIVE SUPPLEMENT NUMBER 1 / AUGUST '83 & SEPTEMBER '83

SPIRONOLACTONE (PAGE 3-166)

TABLET; ORALSPIRONOLACTONE

> ADD > AB PUREPAC/QUALIPHARMA 25MB!

TESTOSTERONE (PAGE 3-173)

INJECTABLE; INJECTIONTESTOSTERONE

> ADD > CARTER-GLOGAU LABS SONG-ML!

TETRACYCLINE HYDROCHLORIDE (PAGE 3-174)

TABLET; ORALPAHHYOIN

> DLT >/99/ UPJOHN léSdNS/SUMYCIN

> DLT >/99/ ER SQUIBB AND SONS 250MB

THEOPHYLLINE (PAGE 3-176)

CAPSULE; CONTROLLED RELEASE; ORALSOMOPHYLLIN-CRT

> ADD > BC FISONS IOOMG> ADD > THEO-24> ADD > BC SEARLE-SEARLE PHARMS IOOMG!> ADD > 2OOMG!> ADD > 3OOMG!

SOLUTION; ORALTHEOLAIR

> ADD > AA RIKER LABS-3M 80MG-15ML> ADD > THEOPHYLLINE> ADD > Q_ ROXANE LABORATORIES BOMGIISML!

TABLET. CONTROLLED RELEASE; ORALTHEOCONTIN

> ADD > BC PURDUE FREDERICK 2OOMG!THEO-DUR

) ADD > BC KEY PHARMACEUTICALS ZOOMG

THIORIDAZINE HYDROCHLORIDE (PAGE 3-178)

CONCENTRATE; ORALTHIORIDAZINE HCL

> ADD > A NATL PHARM MFG-BARRE IOOMGIML!

THIORIDAZINE HYDROCHLORIDE (PAGE 3-178)

TABLET: ORALDELLABIL

> ADD > 99 SANDOZ PHARMS-SANDOZ IOOMGTHIORIDAZINE HCL

> ADD > 99 BOLAR PHARMACEUTICAL IONG!> ADD > 99 Ioousu> ADD > 99 CORO LABORATORIES 10MB!> ADD > 99 15MB!> ADD > 99 25MB!> ADD > 99 SOHO!

TIMOLOL MALEATE (PAGE 3-179)

TABLET; ORALBLOCADREN

> ADD > MS-D-MERCK SMG

TRIAMCINOLONE ACETONIDE (PAGE 3-180)

CREAM; TOPICALTRIAMCINOLONE ACETONIDE

> ADD > 91 BAY LABORATORIES 0.0252u> AOO > 91 0.12:> ADD > 91 0.szu

OINTMENT; TOPICALTRIAMCINOLONE AOETONIOE

> AOO > 91 BAY LABORATORIES 0.0252:> ADD > 9; 0.12m> ADD > 91 0.529

TRISULFAPYRIMIDINES (PAGE 3-105)

SUSPENSION; ORAL>_OLI_> lfRiSéI>_QLI_>/é§/ —7BEE%H§gf£AB$/B££¢HAH/éééfiéléfié/> OLT > TRISURE /> OLT >léé/

/r RVIDENIZIABS/léééfiéiéfii/

TABLET; ORAL> on > mme'sumau>;QLI_>/é§/ . .L TORIESSIAMO/

TROPICAMIDE (PAGE 3-186)

SOLUTION-DROPS; OPHTHALMIC> ADD > HYDRIAFAIR> ADD > 91 PHARMAFAIR 0.52!> ADD > 91 999

DRUGPRODUCTLIST/CUMULATIVESUPPLEMENTNUMBER1/AUGUST>DLT>/fYBANAfE/(PASE3-186)

2EIIZ

/¢5IIII¢/

>OLT>'lisbfip/

VITAMINAPALMITATE(PAGE3-188)

CAPSULE;ORAL

>OLT>/SOLVISTA>_QLI_>/éé/,,I,ULSEN//EO'SO;OOO'UNITS'BASEI

'83&SEPTEMBER'83

ADDENDUMDESI PENDING LIST - 'EXEMPT' (COURT ORDER) CATEGORY

CUMULATIVE SUPPLEMENT NUMBER 1 / AUGUST '83 & SEPTEMBER '83N> 9!; > LOAT IRNEN'INISYIATII'CNEOIRIENIRA'I‘ ‘NALEAIEI'ISORROPANIOE/>Ou>/fic ' mAI Li'PNELYLRROPAIOEA IHL PVC 0 L iDL](PAGE A03)/¢A/PSUL'EI.'IXINJ‘RIIJIEII.'PEIEASEI'PFAI/T‘ S -''

I-IAgSI/IAJ‘IIRIESI /éfifléiéflGiéJSflGiSfiflfi/> /so 'AANIJARLV'

> > 1‘ -'m>/'Ijéfikgfwfigfiilifififiifil HAWAII.iéNE/Sfliifiifi/SHLiiSNS/SNI/

> DLT >>|_T>> DLT >U

DIPYRIDAMOLE (PAGE A04)

TABLET; ORALDIPYRIDAMOLE

> ADD > ASCOT HOSP PHARMS SOMG

DESIPENDINGLIST-OTHERTHAN'EXEMPT'(COURTORDER)CATEGORYCUMULATIVESUPPLEMENTNUMBER1/AUGUST'83&SEPTEMBER'83

CURRENTSTATUS-INEFFECTIVE

.1‘'.-'.v.-" 3‘IIIIK

>>'J‘N'.'.c‘.‘PHAR.’ >3H>“IIAIAIIIIAIAINF.IIIIAII/Hl

>>RRHISJ‘A'/mm/mA-IEIAI/

>III>IF/RINEJ‘HINTIENE‘NALEAIE/

>ADD>TUSS-ORNADESK&FLABORATORIES

>ADD>CARAMIPHENEDISYLATE;CHLORPHENIRAMINEMALEATE;

>ADD>ISOPROPAMIDEIODIDE;PHENYLPROPANOLAMINEHYDROCHLORIDE

‘P(1.5.GOVERNMENTPRINTINGOFFICE:1983-421—9272203

SUBSCRIPTION

FORM

APPROVED

PRESCRIPTION

DRUG

PRODUCTS

WITH

THERAPEUTIC

EQUIVALENCE

EVALUATIONS

4TH

EDITION

(1983)

MAIL

TO:

DATE:

Superintendent

ofDocuments

Government

Printing

Office

Washington,

DC20402

(202)

783-3238

PURCHASER:

SHIP

TO:(If

different

than

purchaser)

CONTACT:

TELEPHONE

(Include

Area

Code)

METHOD

OFPAYMENT

[]

Charge

my

GPO

Account

No.

[]

Purchase

Order

Number

[]

Check

enclosed

for

ST(Make

check

payable

toSuperintendent

OTDocuments)

AUTHORIZING

DATE:

SIGNATURE

DESCRIPTION

QUANTITY

UNIT

PRICE

TOTAL

PRICE

The

4th

Edition

will

bepublished

inOctober,

1983.

Subscription

includes

the

Approved

Prescription

Drug

Products

List

and

monthly

Cumulative

Supplements.

DOMESTIC

O

$67.00

$

FOREIGN

@

$83.75

$

.1’

u‘

.

_________

mmmm

mmmno

m

Pom

m

__

___________

2-O-IO-S_

mo

>.:m¢m>_zd

Front CoverTable of Contents (Page vii)Section 1 (Page viii)