Guidance for industry : changes to an approved NDA or ANDA, specifications, use of enforcement discretion for compendial changes.
| Other author | Center for Drug Evaluation and Research (U.S.) |
| 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 (2 p.) |
| Supplemental Content | https://purl.fdlp.gov/GPO/LPS120724 |
| Subjects |
| Portion of title | Changes to an approved NDA or ANDA, specifications, use of enforcement discretion for compendial changes |
| General note | "CMC." |
| General note | "November 2004." |
| General note | GPO Cataloging Record Distribution Program (CRDP). |
| GPO item number | 0499-T (online) |
| Govt. docs number | HE 20.4702:N 42/3 |
Availability
| Library | Location | Call Number | Status | Item Actions |
|---|---|---|---|---|
| Electronic Resources | Access Content Online | ✔ Available |