Regulations.gov document
References 7 RE Covis Pharma GmbH’s Briefing Materials In Response To The Center for Drug…
Supporting & Related Material · FDA-2020-N-2029 · posted Oct 6, 2022
Key facts
| Document ID | FDA-2020-N-2029-0310 |
|---|---|
| Title | References 7 RE Covis Pharma GmbH’s Briefing Materials In Response To The Center for Drug Research and Evaluation’s Notice Of Opportunity For A Hearing And Proposal To Withdraw Approval Of MAKENA® (hydroxyprogesterone caproate injection) 250 mg/mL (NDA No.: NDA 21-945) |
| Document type | Supporting & Related Material |
| Subtype | Background Material |
| Agency | FDA |
| Docket | FDA-2020-N-2029 |
| Posted | Oct 6, 2022 |
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