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Guidance for industry : listed drugs, 30 month stays, and approval of ANDAs and 505(b)(2) applications under Hatch-Waxman, as amended by the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, questions and answers.
- Format:
- Book
- Government document
- Language:
- English
- Subjects (All):
- United States. Medicare Prescription Drug, Improvement, and Modernization Act of 2003.
- United States.
- Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (United States).
- Drug approval--United States.
- Drug approval.
- Physical Description:
- 1 online resource (12 pages)
- Other Title:
- Listed drugs, 30 month stays, and approval of ANDAs and 505(b)(2) applications under Hatch-Waxman, as amended by the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, 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, [2004]
- Notes:
- "Draft guidance."
- "OGD."
- "October 2004."
- OCLC:
- 471897730
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