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.
| Other author | Center for Drug Evaluation and Research (U.S.). Office of Generic Drugs. |
| Format | Electronic |
| Publication Info | Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, [2004] |
| Description | 1 online resource (12 p.). |
| Supplemental Content | https://purl.fdlp.gov/GPO/LPS117075 |
| Subjects |
| Portion of 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 |
| General note | "Draft guidance." |
| General note | "OGD." |
| General note | "October 2004." |
| General note | GPO Cataloging Record Distribution Program (CRDP). |
| GPO item number | 0499-T (online) |
| Govt. docs number | HE 20.4702:AP 5/DRAFT |
Availability
| Library | Location | Call Number | Status | Item Actions |
|---|---|---|---|---|
| Electronic Resources | Access Content Online | ✔ Available |