Regulations.gov document
Appendix 5 - Addendum to CDER Decisional Memorandum NDA 021945 Makena RE Briefing…
Supporting & Related Material · FDA-2020-N-2029 · posted Oct 6, 2022
Key facts
| Document ID | FDA-2020-N-2029-0279 |
|---|---|
| Title | Appendix 5 - Addendum to CDER Decisional Memorandum NDA 021945 Makena RE Briefing Materials Supporting CDER’s Proposal to Withdraw Approval of Makena |
| Document type | Supporting & Related Material |
| Subtype | Background Material |
| Agency | FDA |
| Docket | FDA-2020-N-2029 |
| Posted | Oct 6, 2022 |
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