Application 012541
- Type
- NDA
- Sponsor
- PHARMACIA AND UPJOHN
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 002 | DEPO-PROVERA | MEDROXYPROGESTERONE ACETATE | INJECTABLE;INJECTION | 100MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 003 | DEPO-PROVERA | MEDROXYPROGESTERONE ACETATE | INJECTABLE;INJECTION | 400MG/ML | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0009-0626 | Depo-Provera | medroxyprogesterone acetate | Pharmacia and Upjohn Company LLC | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 47869 | SUPPL | 2017-04-05 |
| 47853 | SUPPL | 2017-04-04 |
| 47599 | SUPPL | 2017-03-20 |
| 47571 | SUPPL | 2017-03-16 |
| 46453 | SUPPL | 2016-12-21 |
| 46235 | SUPPL | 2016-12-20 |
| 12019 | SUPPL | 2016-06-14 |
| 10813 | SUPPL | 2016-06-13 |
| 33086 | SUPPL | 2015-06-12 |
| 12018 | SUPPL | 2015-06-12 |