Application 011839
- Type
- NDA
- Sponsor
- PHARMACIA AND UPJOHN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PROVERA | MEDROXYPROGESTERONE ACETATE | TABLET;ORAL | 2.5MG | Yes | No |
| 003 | PROVERA | MEDROXYPROGESTERONE ACETATE | TABLET;ORAL | 5MG | Yes | No |
| 004 | PROVERA | MEDROXYPROGESTERONE ACETATE | TABLET;ORAL | 10MG | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N011839-001 | PROVERA | MEDROXYPROGESTERONE ACETATE | 2.5MG | TABLET / ORAL | AB | RLD, Approved before 1982 | |
| N011839-003 | PROVERA | MEDROXYPROGESTERONE ACETATE | 5MG | TABLET / ORAL | AB | RLD, Approved before 1982 | |
| N011839-004 | PROVERA | MEDROXYPROGESTERONE ACETATE | 10MG | TABLET / ORAL | AB | RLD, RS, Approved before 1982 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N011839-001 | AB |
| N011839-003 | AB |
| N011839-004 | AB |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N011839-001 | PROVERA | 2.5MG | TABLET / ORAL | AB | RLD, Approved before 1982 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N011839-003 | PROVERA | 5MG | TABLET / ORAL | AB | RLD, Approved before 1982 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N011839-004 | PROVERA | 10MG | TABLET / ORAL | AB | RLD, RS, Approved before 1982 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N011839-001 | PROVERA | 2.5MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N011839-003 | PROVERA | 5MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N011839-004 | PROVERA | 10MG | TABLET / ORAL | AB | RLD, RS, Approved before 1982 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N011839-001 | PROVERA | 2.5MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N011839-003 | PROVERA | 5MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N011839-004 | PROVERA | 10MG | TABLET / ORAL | AB | RLD, RS, Approved before 1982 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N011839-001 | PROVERA | 2.5MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N011839-003 | PROVERA | 5MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N011839-004 | PROVERA | 10MG | TABLET / ORAL | AB | RLD, RS, Approved before 1982 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N011839-001 | PROVERA | 2.5MG | TABLET / ORAL | AB | RLD, Approved before 1982 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N011839-003 | PROVERA | 5MG | TABLET / ORAL | AB | RLD, Approved before 1982 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N011839-004 | PROVERA | 10MG | TABLET / ORAL | AB | RLD, RS, Approved before 1982 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N011839-001 | PROVERA | 2.5MG | TABLET / ORAL | AB | RLD, Approved before 1982 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N011839-003 | PROVERA | 5MG | TABLET / ORAL | AB | RLD, Approved before 1982 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N011839-004 | PROVERA | 10MG | TABLET / ORAL | AB | RLD, RS, Approved before 1982 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N011839-001 | PROVERA | 2.5MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N011839-003 | PROVERA | 5MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N011839-004 | PROVERA | 10MG | TABLET / ORAL | AB | RLD, RS, Approved before 1982 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N011839-001 | PROVERA | 2.5MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N011839-003 | PROVERA | 5MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N011839-004 | PROVERA | 10MG | TABLET / ORAL | AB | RLD, RS, Approved before 1982 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N011839-001 | PROVERA | 2.5MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N011839-003 | PROVERA | 5MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N011839-004 | PROVERA | 10MG | TABLET / ORAL | AB | RLD, RS, Approved before 1982 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N011839-001 | PROVERA | 2.5MG | TABLET / ORAL | AB | RLD, Approved before 1982 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N011839-003 | PROVERA | 5MG | TABLET / ORAL | AB | RLD, Approved before 1982 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N011839-004 | PROVERA | 10MG | TABLET / ORAL | AB | RLD, RS, Approved before 1982 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N011839-001 | PROVERA | 2.5MG | TABLET / ORAL | AB | RLD, Approved before 1982 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N011839-003 | PROVERA | 5MG | TABLET / ORAL | AB | RLD, Approved before 1982 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N011839-004 | PROVERA | 10MG | TABLET / ORAL | AB | RLD, RS, Approved before 1982 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N011839-001 | PROVERA | 2.5MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N011839-003 | PROVERA | 5MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N011839-004 | PROVERA | 10MG | TABLET / ORAL | AB | RLD, RS, Approved before 1982 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N011839-001 | PROVERA | 2.5MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N011839-003 | PROVERA | 5MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N011839-004 | PROVERA | 10MG | TABLET / ORAL | AB | RLD, RS, Approved before 1982 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N011839-001 | PROVERA | 2.5MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 1e350fbaab3a… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N011839-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N011839-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N011839-004 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N011839-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N011839-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N011839-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N011839-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N011839-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N011839-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N011839-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N011839-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N011839-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N011839-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N011839-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N011839-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N011839-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N011839-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N011839-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N011839-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N011839-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N011839-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N011839-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N011839-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N011839-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N011839-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N011839-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N011839-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N011839-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N011839-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N011839-004 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N011839-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N011839-003 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N011839-004 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N011839-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N011839-003 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N011839-004 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N011839-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N011839-003 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N011839-004 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N011839-001 | AB | 1 | 1e350fbaab3a… |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Provera | MEDROXYPROGESTERONE ACETATE | Pharmacia & Upjohn Company LLC | a586be28-96af-4fed-a13f-9b94fd4c7405 | 2026-06-29 | Boxed warning, Warnings, Adverse reactions | 011839 NDA011839 0009-0051 0009-0065 0009-0287 |
| medroxyprogesterone acetate | MEDROXYPROGESTERONE ACETATE | Mylan Pharmaceuticals Inc. | 2627eb11-06bf-4a45-9172-094468e3ca07 | 2026-05-21 | Boxed warning, Warnings, Adverse reactions | 011839 NDA011839 59762-0058 59762-0055 59762-0056 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0009-0050 | Provera | medroxyprogesterone acetate | Pharmacia and Upjohn Company LLC | NDA | Current |
| 0009-0050 | Provera | medroxyprogesterone acetate | Pharmacia and Upjohn Company LLC | NDA | Current |
| 0009-0050 | Provera | medroxyprogesterone acetate | Pharmacia and Upjohn Company | NDA | Current |
| 0009-0050 | Provera | medroxyprogesterone acetate | Pharmacia and Upjohn Company LLC | NDA | Current |
| 0009-0050 | Provera | medroxyprogesterone acetate | Pharmacia and Upjohn Company LLC | NDA | Current |
| 0009-0051 | Provera | medroxyprogesterone acetate | Pharmacia and Upjohn Company LLC | NDA | Current |
| 0009-0051 | Provera | medroxyprogesterone acetate | Pharmacia and Upjohn Company LLC | NDA | Current |
| 0009-0051 | Provera | medroxyprogesterone acetate | Pharmacia and Upjohn Company | NDA | Current |
| 0009-0051 | Provera | medroxyprogesterone acetate | Pharmacia and Upjohn Company LLC | NDA | Current |
| 0009-0051 | Provera | medroxyprogesterone acetate | Pharmacia and Upjohn Company | NDA | Current |
| 0009-0064 | Provera | medroxyprogesterone acetate | Pharmacia and Upjohn Company LLC | NDA | Current |
| 0009-0064 | Provera | medroxyprogesterone acetate | Pharmacia and Upjohn Company LLC | NDA | Current |
| 0009-0064 | Provera | medroxyprogesterone acetate | Pharmacia and Upjohn Company LLC | NDA | Current |
| 0009-0065 | Provera | medroxyprogesterone acetate | Pharmacia and Upjohn Company LLC | NDA | Current |
| 0009-0065 | Provera | medroxyprogesterone acetate | Pharmacia and Upjohn Company LLC | NDA | Current |
| 0009-0065 | Provera | medroxyprogesterone acetate | Pharmacia and Upjohn Company | NDA | Current |
| 0009-0065 | Provera | medroxyprogesterone acetate | Pharmacia and Upjohn Company LLC | NDA | Current |
| 0009-0065 | Provera | medroxyprogesterone acetate | Pharmacia and Upjohn Company | NDA | Current |
| 0009-0286 | Provera | medroxyprogesterone acetate | Pharmacia and Upjohn Company LLC | NDA | Current |
| 0009-0286 | Provera | medroxyprogesterone acetate | Pharmacia and Upjohn Company LLC | NDA | Current |
| 0009-0286 | Provera | medroxyprogesterone acetate | Pharmacia and Upjohn Company | NDA | Current |
| 0009-0286 | Provera | medroxyprogesterone acetate | Pharmacia and Upjohn Company LLC | NDA | Current |
| 0009-0286 | Provera | medroxyprogesterone acetate | Pharmacia and Upjohn Company LLC | NDA | Current |
| 0009-0286 | Provera | medroxyprogesterone acetate | Pharmacia and Upjohn Company | NDA | Current |
| 0009-0287 | Provera | medroxyprogesterone acetate | Pharmacia and Upjohn Company LLC | NDA | Current |
| 0009-0287 | Provera | medroxyprogesterone acetate | Pharmacia and Upjohn Company LLC | NDA | Current |
| 0009-0287 | Provera | medroxyprogesterone acetate | Pharmacia and Upjohn Company | NDA | Current |
| 0009-0287 | Provera | medroxyprogesterone acetate | Pharmacia and Upjohn Company LLC | NDA | Current |
| 0009-0287 | Provera | medroxyprogesterone acetate | Pharmacia and Upjohn Company LLC | NDA | Current |
| 0009-0287 | Provera | medroxyprogesterone acetate | Pharmacia and Upjohn Company | NDA | Current |
| 43063-438 | medroxyprogesterone acetate | medroxyprogesterone acetate | PD-Rx Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | Current |
| 43063-438 | medroxyprogesterone acetate | medroxyprogesterone acetate | PD-Rx Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | Current |
| 43063-438 | medroxyprogesterone acetate | medroxyprogesterone acetate | PD-Rx Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | Current |
| 43063-438 | medroxyprogesterone acetate | medroxyprogesterone acetate | PD-Rx Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | Current |
| 55289-816 | medroxyprogesterone acetate | medroxyprogesterone acetate | PD-Rx Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | Current |
| 55289-816 | medroxyprogesterone acetate | medroxyprogesterone acetate | PD-Rx Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | Current |
| 55289-816 | medroxyprogesterone acetate | medroxyprogesterone acetate | PD-Rx Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | Current |
| 55289-816 | medroxyprogesterone acetate | medroxyprogesterone acetate | PD-Rx Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | Current |
| 55289-816 | medroxyprogesterone acetate | medroxyprogesterone acetate | PD-Rx Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | Current |
| 55289-816 | medroxyprogesterone acetate | medroxyprogesterone acetate | PD-Rx Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | Current |
| 55289-816 | medroxyprogesterone acetate | medroxyprogesterone acetate | PD-Rx Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | Current |
| 55289-908 | medroxyprogesterone acetate | medroxyprogesterone acetate | PD-Rx Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | Current |
| 55289-908 | medroxyprogesterone acetate | medroxyprogesterone acetate | PD-Rx Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | Current |
| 55289-908 | medroxyprogesterone acetate | medroxyprogesterone acetate | PD-Rx Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | Current |
| 55289-908 | medroxyprogesterone acetate | medroxyprogesterone acetate | PD-Rx Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | Current |
| 55289-908 | medroxyprogesterone acetate | medroxyprogesterone acetate | PD-Rx Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | Current |
| 55289-908 | medroxyprogesterone acetate | medroxyprogesterone acetate | PD-Rx Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | Current |
| 55289-908 | medroxyprogesterone acetate | medroxyprogesterone acetate | PD-Rx Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC | Current |
| 55700-699 | medroxyprogesterone acetate | medroxyprogesterone acetate | Quality Care Products, LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-0055 | medroxyprogesterone acetate | medroxyprogesterone acetate | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-0055 | medroxyprogesterone acetate | medroxyprogesterone acetate | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-0055 | medroxyprogesterone acetate | medroxyprogesterone acetate | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-0055 | medroxyprogesterone acetate | medroxyprogesterone acetate | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-0055 | medroxyprogesterone acetate | medroxyprogesterone acetate | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-0055 | medroxyprogesterone acetate | medroxyprogesterone acetate | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-0055 | medroxyprogesterone acetate | medroxyprogesterone acetate | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-0055 | medroxyprogesterone acetate | medroxyprogesterone acetate | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-0055 | medroxyprogesterone acetate | medroxyprogesterone acetate | Greenstone LLC | NDA AUTHORIZED | Current |
| 59762-0055 | medroxyprogesterone acetate | medroxyprogesterone acetate | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-0056 | medroxyprogesterone acetate | medroxyprogesterone acetate | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-0056 | medroxyprogesterone acetate | medroxyprogesterone acetate | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-0056 | medroxyprogesterone acetate | medroxyprogesterone acetate | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-0056 | medroxyprogesterone acetate | medroxyprogesterone acetate | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-0056 | medroxyprogesterone acetate | medroxyprogesterone acetate | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-0056 | medroxyprogesterone acetate | medroxyprogesterone acetate | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-0056 | medroxyprogesterone acetate | medroxyprogesterone acetate | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-0056 | medroxyprogesterone acetate | medroxyprogesterone acetate | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-0058 | medroxyprogesterone acetate | medroxyprogesterone acetate | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-0058 | medroxyprogesterone acetate | medroxyprogesterone acetate | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-0058 | medroxyprogesterone acetate | medroxyprogesterone acetate | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-0058 | medroxyprogesterone acetate | medroxyprogesterone acetate | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-0058 | medroxyprogesterone acetate | medroxyprogesterone acetate | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-0058 | medroxyprogesterone acetate | medroxyprogesterone acetate | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-0058 | medroxyprogesterone acetate | medroxyprogesterone acetate | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-0058 | medroxyprogesterone acetate | medroxyprogesterone acetate | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-0058 | medroxyprogesterone acetate | medroxyprogesterone acetate | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-3740 | medroxyprogesterone acetate | medroxyprogesterone acetate | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-3740 | medroxyprogesterone acetate | medroxyprogesterone acetate | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-3740 | medroxyprogesterone acetate | medroxyprogesterone acetate | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-3740 | medroxyprogesterone acetate | medroxyprogesterone acetate | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 77563 | SUPPL | 2024-02-20 |
| 77538 | SUPPL | 2024-02-16 |
| 75986 | SUPPL | 2023-10-30 |
| 75983 | SUPPL | 2023-10-30 |
| 11968 | SUPPL | 2015-05-11 |
| 290 | SUPPL | 2015-05-11 |
| 10783 | SUPPL | 2015-05-08 |
| 10782 | SUPPL | 2015-05-08 |
| 11967 | SUPPL | 2007-10-04 |
| 10781 | SUPPL | 2007-10-04 |
| 40676 | SUPPL | 1998-08-04 |
| 11966 | SUPPL | 1998-08-04 |