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CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 209501Orig1s000 ADMINISTRATIVE and CORRESPONDENCE DOCUMENTS

209501Orig1s000 - Food and Drug Administration...Guidance for Industry: Q3B(R2) Impurities in New Drug Products es/ucm073389.pdf We note that all NDA applications filed after June

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Page 1: 209501Orig1s000 - Food and Drug Administration...Guidance for Industry: Q3B(R2) Impurities in New Drug Products es/ucm073389.pdf We note that all NDA applications filed after June

CENTER FOR DRUG EVALUATION AND RESEARCH

APPLICATION NUMBER:

209501Orig1s000

ADMINISTRATIVE and CORRESPONDENCE DOCUMENTS

Page 2: 209501Orig1s000 - Food and Drug Administration...Guidance for Industry: Q3B(R2) Impurities in New Drug Products es/ucm073389.pdf We note that all NDA applications filed after June

Reference ID: 4171138

Page 3: 209501Orig1s000 - Food and Drug Administration...Guidance for Industry: Q3B(R2) Impurities in New Drug Products es/ucm073389.pdf We note that all NDA applications filed after June

Reference ID: 4171138

Page 4: 209501Orig1s000 - Food and Drug Administration...Guidance for Industry: Q3B(R2) Impurities in New Drug Products es/ucm073389.pdf We note that all NDA applications filed after June

Reference ID: 4171138

Page 5: 209501Orig1s000 - Food and Drug Administration...Guidance for Industry: Q3B(R2) Impurities in New Drug Products es/ucm073389.pdf We note that all NDA applications filed after June

Page 6: 209501Orig1s000 - Food and Drug Administration...Guidance for Industry: Q3B(R2) Impurities in New Drug Products es/ucm073389.pdf We note that all NDA applications filed after June

Page 7: 209501Orig1s000 - Food and Drug Administration...Guidance for Industry: Q3B(R2) Impurities in New Drug Products es/ucm073389.pdf We note that all NDA applications filed after June

Page 8: 209501Orig1s000 - Food and Drug Administration...Guidance for Industry: Q3B(R2) Impurities in New Drug Products es/ucm073389.pdf We note that all NDA applications filed after June

Page 9: 209501Orig1s000 - Food and Drug Administration...Guidance for Industry: Q3B(R2) Impurities in New Drug Products es/ucm073389.pdf We note that all NDA applications filed after June

Reference ID: 4171138

Page 10: 209501Orig1s000 - Food and Drug Administration...Guidance for Industry: Q3B(R2) Impurities in New Drug Products es/ucm073389.pdf We note that all NDA applications filed after June

Reference ID: 4171138

Page 11: 209501Orig1s000 - Food and Drug Administration...Guidance for Industry: Q3B(R2) Impurities in New Drug Products es/ucm073389.pdf We note that all NDA applications filed after June

Page 12: 209501Orig1s000 - Food and Drug Administration...Guidance for Industry: Q3B(R2) Impurities in New Drug Products es/ucm073389.pdf We note that all NDA applications filed after June

Page 13: 209501Orig1s000 - Food and Drug Administration...Guidance for Industry: Q3B(R2) Impurities in New Drug Products es/ucm073389.pdf We note that all NDA applications filed after June

Page 14: 209501Orig1s000 - Food and Drug Administration...Guidance for Industry: Q3B(R2) Impurities in New Drug Products es/ucm073389.pdf We note that all NDA applications filed after June

Reference ID: 4171138

Page 15: 209501Orig1s000 - Food and Drug Administration...Guidance for Industry: Q3B(R2) Impurities in New Drug Products es/ucm073389.pdf We note that all NDA applications filed after June

Reference ID: 4171138

Page 16: 209501Orig1s000 - Food and Drug Administration...Guidance for Industry: Q3B(R2) Impurities in New Drug Products es/ucm073389.pdf We note that all NDA applications filed after June

Reference ID: 4171138

Page 17: 209501Orig1s000 - Food and Drug Administration...Guidance for Industry: Q3B(R2) Impurities in New Drug Products es/ucm073389.pdf We note that all NDA applications filed after June

Reference ID: 4171138

Page 18: 209501Orig1s000 - Food and Drug Administration...Guidance for Industry: Q3B(R2) Impurities in New Drug Products es/ucm073389.pdf We note that all NDA applications filed after June

Reference ID: 4171138

Page 19: 209501Orig1s000 - Food and Drug Administration...Guidance for Industry: Q3B(R2) Impurities in New Drug Products es/ucm073389.pdf We note that all NDA applications filed after June

Reference ID: 4171138

Page 20: 209501Orig1s000 - Food and Drug Administration...Guidance for Industry: Q3B(R2) Impurities in New Drug Products es/ucm073389.pdf We note that all NDA applications filed after June

Page 21: 209501Orig1s000 - Food and Drug Administration...Guidance for Industry: Q3B(R2) Impurities in New Drug Products es/ucm073389.pdf We note that all NDA applications filed after June

Reference ID: 4171138

Page 22: 209501Orig1s000 - Food and Drug Administration...Guidance for Industry: Q3B(R2) Impurities in New Drug Products es/ucm073389.pdf We note that all NDA applications filed after June

Reference ID: 4171138

Page 23: 209501Orig1s000 - Food and Drug Administration...Guidance for Industry: Q3B(R2) Impurities in New Drug Products es/ucm073389.pdf We note that all NDA applications filed after June

Page 24: 209501Orig1s000 - Food and Drug Administration...Guidance for Industry: Q3B(R2) Impurities in New Drug Products es/ucm073389.pdf We note that all NDA applications filed after June

Page 25: 209501Orig1s000 - Food and Drug Administration...Guidance for Industry: Q3B(R2) Impurities in New Drug Products es/ucm073389.pdf We note that all NDA applications filed after June

Reference ID: 4171138

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