Application 020246
- Type
- NDA
- Sponsor
- PHARMACIA AND UPJOHN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DEPO-PROVERA | MEDROXYPROGESTERONE ACETATE | INJECTABLE;INJECTION | 150MG/ML | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N020246-001 | DEPO-PROVERA | MEDROXYPROGESTERONE ACETATE | 150MG/ML | INJECTABLE / INJECTION | AB | RLD, RS | 1992-10-29 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N020246-001 | 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 | N020246-001 | DEPO-PROVERA | 150MG/ML | INJECTABLE / INJECTION | AB | RLD, RS | 1992-10-29 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N020246-001 | DEPO-PROVERA | 150MG/ML | INJECTABLE / INJECTION | AB | RLD, RS | 1992-10-29 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020246-001 | DEPO-PROVERA | 150MG/ML | INJECTABLE / INJECTION | AB | RLD, RS | 1992-10-29 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N020246-001 | DEPO-PROVERA | 150MG/ML | INJECTABLE / INJECTION | AB | RLD, RS | 1992-10-29 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020246-001 | DEPO-PROVERA | 150MG/ML | INJECTABLE / INJECTION | AB | RLD, RS | 1992-10-29 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020246-001 | DEPO-PROVERA | 150MG/ML | INJECTABLE / INJECTION | AB | RLD, RS | 1992-10-29 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020246-001 | DEPO-PROVERA | 150MG/ML | INJECTABLE / INJECTION | AB | RLD, RS | 1992-10-29 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020246-001 | DEPO-PROVERA | 150MG/ML | INJECTABLE / INJECTION | AB | RLD, RS | 1992-10-29 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020246-001 | DEPO-PROVERA | 150MG/ML | INJECTABLE / INJECTION | AB | RLD, RS | 1992-10-29 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020246-001 | DEPO-PROVERA | 150MG/ML | INJECTABLE / INJECTION | AB | RLD, RS | 1992-10-29 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N020246-001 | DEPO-PROVERA | 150MG/ML | INJECTABLE / INJECTION | AB | RLD, RS | 1992-10-29 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020246-001 | DEPO-PROVERA | 150MG/ML | INJECTABLE / INJECTION | AB | RLD, RS | 1992-10-29 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020246-001 | DEPO-PROVERA | 150MG/ML | INJECTABLE / INJECTION | AB | RLD, RS | 1992-10-29 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N020246-001 | DEPO-PROVERA | 150MG/ML | INJECTABLE / INJECTION | AB | RLD, RS | 1992-10-29 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N020246-001 | DEPO-PROVERA | 150MG/ML | INJECTABLE / INJECTION | AB | RLD, RS | 1992-10-29 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020246-001 | DEPO-PROVERA | 150MG/ML | INJECTABLE / INJECTION | AB | RLD, RS | 1992-10-29 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N020246-001 | DEPO-PROVERA | 150MG/ML | INJECTABLE / INJECTION | AB | RLD, RS | 1992-10-29 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N020246-001 | DEPO-PROVERA | 150MG/ML | INJECTABLE / INJECTION | AB | RLD, RS | 1992-10-29 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N020246-001 | DEPO-PROVERA | 150MG/ML | INJECTABLE / INJECTION | AB | RLD, RS | 1992-10-29 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N020246-001 | DEPO-PROVERA | 150MG/ML | INJECTABLE / INJECTION | AB | RLD, RS | 1992-10-29 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N020246-001 | DEPO-PROVERA | 150MG/ML | INJECTABLE / INJECTION | AB | RLD, RS | 1992-10-29 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N020246-001 | DEPO-PROVERA | 150MG/ML | INJECTABLE / INJECTION | AB | RLD, RS | 1992-10-29 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N020246-001 | DEPO-PROVERA | 150MG/ML | INJECTABLE / INJECTION | AB | RLD, RS | 1992-10-29 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N020246-001 | DEPO-PROVERA | 150MG/ML | INJECTABLE / INJECTION | AB | RLD, RS | 1992-10-29 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N020246-001 | DEPO-PROVERA | 150MG/ML | INJECTABLE / INJECTION | AB | RLD, RS | 1992-10-29 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N020246-001 | DEPO-PROVERA | 150MG/ML | INJECTABLE / INJECTION | AB | RLD, RS | 1992-10-29 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N020246-001 | DEPO-PROVERA | 150MG/ML | INJECTABLE / INJECTION | AB | RLD, RS | 1992-10-29 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N020246-001 | DEPO-PROVERA | 150MG/ML | INJECTABLE / INJECTION | AB | RLD, RS | 1992-10-29 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N020246-001 | DEPO-PROVERA | 150MG/ML | INJECTABLE / INJECTION | AB | RLD, RS | 1992-10-29 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | N020246-001 | DEPO-PROVERA | 150MG/ML | INJECTABLE / INJECTION | AB | RLD, RS | 1992-10-29 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | N020246-001 | DEPO-PROVERA | 150MG/ML | INJECTABLE / INJECTION | AB | RLD, RS | 1992-10-29 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N020246-001 | DEPO-PROVERA | 150MG/ML | INJECTABLE / INJECTION | AB | RLD, RS | 1992-10-29 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N020246-001 | DEPO-PROVERA | 150MG/ML | INJECTABLE / INJECTION | AB | RLD, RS | 1992-10-29 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N020246-001 | DEPO-PROVERA | 150MG/ML | INJECTABLE / INJECTION | AB | RLD, RS | 1992-10-29 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N020246-001 | DEPO-PROVERA | 150MG/ML | INJECTABLE / INJECTION | AB | RLD, RS | 1992-10-29 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | N020246-001 | DEPO-PROVERA | 150MG/ML | INJECTABLE / INJECTION | AB | RLD, RS | 1992-10-29 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | N020246-001 | DEPO-PROVERA | 150MG/ML | INJECTABLE / INJECTION | AB | RLD, RS | 1992-10-29 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N020246-001 | DEPO-PROVERA | 150MG/ML | INJECTABLE / INJECTION | AB | RLD, RS | 1992-10-29 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | N020246-001 | DEPO-PROVERA | 150MG/ML | INJECTABLE / INJECTION | AB | RLD, RS | 1992-10-29 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | N020246-001 | DEPO-PROVERA | 150MG/ML | INJECTABLE / INJECTION | AB | RLD, RS | 1992-10-29 | e64feba35796… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N020246-001 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N020246-001 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020246-001 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N020246-001 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020246-001 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020246-001 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020246-001 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020246-001 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020246-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020246-001 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N020246-001 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020246-001 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020246-001 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N020246-001 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N020246-001 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020246-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N020246-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N020246-001 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N020246-001 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N020246-001 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N020246-001 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N020246-001 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N020246-001 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N020246-001 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N020246-001 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N020246-001 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N020246-001 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N020246-001 | AB | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N020246-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | N020246-001 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | N020246-001 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N020246-001 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N020246-001 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N020246-001 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N020246-001 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | N020246-001 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | N020246-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N020246-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | N020246-001 | AB | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | N020246-001 | AB | 1 | e64feba35796… |
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 |
|---|---|---|---|---|---|---|
| medroxyprogesterone acetate | MEDROXYPROGESTERONE ACETATE | Prasco Laboratories | 987496bf-b4b0-409b-b745-f52ed0871f4e | 2026-07-21 | Boxed warning, Warnings, Adverse reactions | 020246 NDA020246 66993-370 66993-371 |
| medroxyprogesterone acetate | MEDROXYPROGESTERONE ACETATE | A-S Medication Solutions | 5e817926-ba15-4d16-9463-88f6ff3bd3ac | 2026-02-23 | Boxed warning, Warnings, Adverse reactions | 020246 NDA020246 50090-5619 |
| Depo-Provera | MEDROXYPROGESTERONE ACETATE | Pharmacia & Upjohn Company LLC | 199cf13e-0859-4a73-9b45-e700d0cd1049 | 2025-12-18 | Boxed warning, Warnings, Adverse reactions | 020246 NDA020246 0009-0746 0009-7376 |
| medroxyprogesterone acetate | MEDROXYPROGESTERONE ACETATE | A-S Medication Solutions | ca344c55-5251-470f-9243-eceb9e496e3e | 2023-10-23 | Boxed warning, Warnings, Adverse reactions | 020246 NDA020246 50090-5925 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0009-0746 | Depo-Provera | medroxyprogesterone acetate | Pharmacia and Upjohn Company LLC | NDA | Current |
| 0009-0746 | Depo-Provera | medroxyprogesterone acetate | Pharmacia and Upjohn Company LLC | NDA | Current |
| 0009-0746 | Depo-Provera | medroxyprogesterone acetate | Pharmacia & Upjohn Company LLC | NDA | Current |
| 0009-0746 | Depo-Provera | medroxyprogesterone acetate | Pharmacia & Upjohn Company LLC | NDA | Current |
| 0009-0746 | Depo-Provera | medroxyprogesterone acetate | Pharmacia and Upjohn Company LLC | NDA | Current |
| 0009-7376 | Depo-Provera | medroxyprogesterone acetate | Pharmacia and Upjohn Company LLC | NDA | Current |
| 0009-7376 | Depo-Provera | medroxyprogesterone acetate | Pharmacia and Upjohn Company LLC | NDA | Current |
| 0009-7376 | Depo-Provera | medroxyprogesterone acetate | Pharmacia & Upjohn Company LLC | NDA | Current |
| 0009-7376 | Depo-Provera | medroxyprogesterone acetate | Pharmacia & Upjohn Company LLC | NDA | Current |
| 0009-7376 | Depo-Provera | medroxyprogesterone acetate | Pharmacia and Upjohn Company LLC | NDA | Current |
| 50090-0459 | Depo-Provera | medroxyprogesterone acetate | A-S Medication Solutions | NDA | Current |
| 50090-0665 | Depo-Provera | medroxyprogesterone acetate | A-S Medication Solutions | NDA | Current |
| 50090-0665 | Depo-Provera | medroxyprogesterone acetate | A-S Medication Solutions | NDA | Current |
| 50090-0665 | Depo-Provera | medroxyprogesterone acetate | A-S Medication Solutions | NDA | Current |
| 50090-0883 | medroxyprogesterone acetate | medroxyprogesterone acetate | A-S Medication Solutions | NDA AUTHORIZED GENERIC | Current |
| 50090-0883 | medroxyprogesterone acetate | medroxyprogesterone acetate | A-S Medication Solutions | NDA AUTHORIZED GENERIC | Current |
| 50090-0883 | medroxyprogesterone acetate | medroxyprogesterone acetate | A-S Medication Solutions | NDA AUTHORIZED GENERIC | Current |
| 50090-0883 | medroxyprogesterone acetate | medroxyprogesterone acetate | A-S Medication Solutions | NDA AUTHORIZED | Current |
| 50090-0883 | medroxyprogesterone acetate | medroxyprogesterone acetate | A-S Medication Solutions | NDA AUTHORIZED GENERIC | Current |
| 50090-3328 | medroxyprogesterone acetate | medroxyprogesterone acetate | A-S Medication Solutions | NDA AUTHORIZED GENERIC | Current |
| 50090-3328 | medroxyprogesterone acetate | medroxyprogesterone acetate | A-S Medication Solutions | NDA AUTHORIZED GENERIC | Current |
| 50090-3328 | medroxyprogesterone acetate | medroxyprogesterone acetate | A-S Medication Solutions | NDA AUTHORIZED GENERIC | Current |
| 50090-3328 | medroxyprogesterone acetate | medroxyprogesterone acetate | A-S Medication Solutions | NDA AUTHORIZED GENERIC | Current |
| 50090-3328 | medroxyprogesterone acetate | medroxyprogesterone acetate | A-S Medication Solutions | NDA AUTHORIZED | Current |
| 50090-3328 | medroxyprogesterone acetate | medroxyprogesterone acetate | A-S Medication Solutions | NDA AUTHORIZED GENERIC | Current |
| 50090-5619 | medroxyprogesterone acetate | medroxyprogesterone acetate | A-S Medication Solutions | NDA AUTHORIZED GENERIC | Current |
| 50090-5925 | medroxyprogesterone acetate | medroxyprogesterone acetate | A-S Medication Solutions | NDA AUTHORIZED GENERIC | Current |
| 52125-915 | medroxyprogesterone acetate | medroxyprogesterone acetate | REMEDYREPACK INC. | NDA AUTHORIZED GENERIC | Current |
| 59762-4537 | medroxyprogesterone acetate | medroxyprogesterone acetate | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-4537 | medroxyprogesterone acetate | medroxyprogesterone acetate | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-4537 | medroxyprogesterone acetate | medroxyprogesterone acetate | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-4538 | medroxyprogesterone acetate | medroxyprogesterone acetate | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-4538 | medroxyprogesterone acetate | medroxyprogesterone acetate | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-4538 | medroxyprogesterone acetate | medroxyprogesterone acetate | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 66993-370 | medroxyprogesterone acetate | medroxyprogesterone acetate | Prasco Laboratories | NDA AUTHORIZED GENERIC | Current |
| 66993-370 | medroxyprogesterone acetate | medroxyprogesterone acetate | Prasco Laboratories | NDA AUTHORIZED GENERIC | Current |
| 66993-370 | medroxyprogesterone acetate | medroxyprogesterone acetate | Prasco Laboratories | NDA AUTHORIZED GENERIC | Current |
| 66993-370 | medroxyprogesterone acetate | medroxyprogesterone acetate | Prasco Laboratories | NDA AUTHORIZED GENERIC | Current |
| 66993-370 | medroxyprogesterone acetate | medroxyprogesterone acetate | Prasco Laboratories | NDA AUTHORIZED GENERIC | Current |
| 66993-370 | medroxyprogesterone acetate | medroxyprogesterone acetate | Prasco Laboratories | NDA AUTHORIZED GENERIC | Current |
| 66993-371 | medroxyprogesterone acetate | medroxyprogesterone acetate | Prasco Laboratories | NDA AUTHORIZED GENERIC | Current |
| 68788-9233 | medroxyprogesterone acetate | medroxyprogesterone acetate | Preferred Pharmaceuticals, Inc | NDA AUTHORIZED GENERIC | Current |
| 70518-1932 | medroxyprogesterone acetate | medroxyprogesterone acetate | REMEDYREPACK INC. | NDA AUTHORIZED GENERIC | Current |
| 70518-1932 | medroxyprogesterone acetate | medroxyprogesterone acetate | REMEDYREPACK INC. | NDA AUTHORIZED GENERIC | Current |
| 70518-1932 | medroxyprogesterone acetate | medroxyprogesterone acetate | REMEDYREPACK INC. | NDA AUTHORIZED GENERIC | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 84448 | SUPPL | 2025-12-18 |
| 84409 | SUPPL | 2025-12-15 |
| 79083 | SUPPL | 2024-07-15 |
| 79061 | SUPPL | 2024-07-15 |
| 77711 | SUPPL | 2024-03-05 |
| 77710 | SUPPL | 2024-03-05 |
| 65572 | SUPPL | 2020-12-10 |
| 65571 | SUPPL | 2020-12-10 |
| 65516 | SUPPL | 2020-12-08 |
| 65515 | SUPPL | 2020-12-08 |
| 64545 | SUPPL | 2020-09-10 |
| 64542 | SUPPL | 2020-09-10 |
| 64541 | SUPPL | 2020-09-10 |
| 64539 | SUPPL | 2020-09-10 |
| 48863 | SUPPL | 2017-06-29 |
| 47591 | SUPPL | 2017-03-20 |
| 46451 | SUPPL | 2016-12-21 |
| 46290 | SUPPL | 2016-12-20 |
| 12372 | SUPPL | 2015-02-03 |
| 2243 | SUPPL | 2015-02-02 |
| 34428 | SUPPL | 2015-01-29 |
| 24656 | SUPPL | 2015-01-26 |
| 41230 | SUPPL | 2014-08-05 |
| 20555 | SUPPL | 2014-08-05 |
| 20554 | SUPPL | 2014-08-05 |
| 20553 | SUPPL | 2014-08-05 |
| 12371 | SUPPL | 2011-08-05 |
| 24655 | SUPPL | 2011-08-01 |
| 34427 | SUPPL | 2010-10-19 |
| 2242 | SUPPL | 2010-10-19 |
| 24654 | SUPPL | 2005-11-01 |
| 12368 | SUPPL | 2005-11-01 |
| 12370 | SUPPL | 2004-12-03 |
| 2241 | SUPPL | 2004-12-02 |
| 12369 | SUPPL | 2003-06-08 |
| 2240 | SUPPL | 2003-06-08 |