2 options
Guidance for industry : changes to an approved NDA or ANDA, questions and answers.
- Format:
- Book
- Government document
- Language:
- English
- Subjects (All):
- Drug approval--United States.
- Drug approval.
- United States.
- Physical Description:
- 1 online resource (1 electronic resource (11 pages))
- Other Title:
- Changes to an approved NDA or ANDA, questions and answers
- Place of Publication:
- Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, [2001]
- Notes:
- "CMC."
- "January 2001."
- OCLC:
- 560319688
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