Application 019781
- Type
- NDA
- Sponsor
- VIRTUS PHARMS
Related Records
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PROMETRIUM | PROGESTERONE | CAPSULE;ORAL | 100MG | Yes | No |
| 002 | PROMETRIUM | PROGESTERONE | CAPSULE;ORAL | 200MG | Yes | Yes |
| 003 | PROMETRIUM | PROGESTERONE | CAPSULE;ORAL | 300MG | No | No |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 50090-3240 | Progesterone | Progesterone | A-S Medication Solutions | NDA | Current |
| 50090-3240 | Progesterone | Progesterone | A-S Medication Solutions | NDA | Current |
| 50090-3240 | Progesterone | Progesterone | A-S Medication Solutions | NDA | Current |
| 63629-7475 | Progesterone | Progesterone | Bryant Ranch Prepack | NDA | Current |
| 63629-7475 | Progesterone | Progesterone | Bryant Ranch Prepack | NDA | Current |
| 63629-7475 | Progesterone | Progesterone | Bryant Ranch Prepack | NDA | Current |
| 63629-8530 | Progesterone | Progesterone | Bryant Ranch Prepack | NDA | Current |
| 63629-8530 | Progesterone | Progesterone | Bryant Ranch Prepack | NDA | Current |
| 69543-372 | Prometrium | Progesterone | Virtus Pharmaceuticals | NDA | Current |
| 69543-372 | Prometrium | Progesterone | Virtus Pharmaceuticals | NDA | Current |
| 69543-372 | Prometrium | Progesterone | Virtus Pharmaceuticals | NDA | Current |
| 69543-372 | Prometrium | Progesterone | Virtus Pharmaceuticals | NDA | Current |
| 69543-373 | Prometrium | Progesterone | Virtus Pharmaceuticals | NDA | Current |
| 69543-373 | Prometrium | Progesterone | Virtus Pharmaceuticals | NDA | Current |
| 69543-373 | Prometrium | Progesterone | Virtus Pharmaceuticals | NDA | Current |
| 69543-373 | Prometrium | Progesterone | Virtus Pharmaceuticals | NDA | Current |
| 69543-374 | Progesterone | Progesterone | Virtus Pharmaceuticals | NDA | Current |
| 69543-374 | Progesterone | Progesterone | Virtus Pharmaceuticals | NDA | Current |
| 69543-374 | Progesterone | Progesterone | Virtus Pharmaceuticals | NDA | Current |
| 69543-375 | Progesterone | Progesterone | Virtus Pharmaceuticals | NDA | Current |
| 69543-375 | Progesterone | Progesterone | Virtus Pharmaceuticals | NDA | Current |
| 69543-375 | Progesterone | Progesterone | Virtus Pharmaceuticals | NDA | Current |
| 72989-372 | Prometrium | Progesterone | Acertis Pharmaceuticals, LLC | NDA | Current |
| 72989-373 | Prometrium | Progesterone | Acertis Pharmaceuticals, LLC | NDA | Current |
Documents
| Document | Submission type | Date |
|---|---|---|
| 85032 | SUPPL | 2026-02-12 |
| 85013 | SUPPL | 2026-02-12 |
| 77562 | SUPPL | 2024-02-20 |
| 77536 | SUPPL | 2024-02-16 |
| 71518 | SUPPL | 2022-07-05 |
| 71513 | SUPPL | 2022-07-05 |
| 11715 | SUPPL | 2011-11-04 |
| 19215 | SUPPL | 2011-11-03 |
| 1615 | SUPPL | 2009-07-07 |
| 33950 | SUPPL | 2009-07-06 |
| 19214 | SUPPL | 2004-03-10 |
| 20350 | ORIG | 1998-05-14 |
| 11714 | ORIG | 1998-05-14 |
| 1614 | ORIG | 1998-05-14 |