Application 012541
- Type
- NDA
- Sponsor
- PHARMACIA AND UPJOHN
Application Products#
| 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ACETATE | INJECTABLE;INJECTION | 100MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N012541-002 | DEPO-PROVERA | MEDROXYPROGESTERONE ACETATE | 100MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | ||
| N012541-003 | DEPO-PROVERA | MEDROXYPROGESTERONE ACETATE | 400MG/ML | INJECTABLE / INJECTION | RLD, Approved before 1982 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N012541-002 | DEPO-PROVERA | 100MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N012541-003 | DEPO-PROVERA | 400MG/ML | INJECTABLE / INJECTION | RLD, Approved before 1982 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | N012541-002 | DEPO-PROVERA | 100MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N012541-003 | DEPO-PROVERA | 400MG/ML | INJECTABLE / INJECTION | RLD, Approved before 1982 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N012541-002 | DEPO-PROVERA | 100MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N012541-003 | DEPO-PROVERA | 400MG/ML | INJECTABLE / INJECTION | RLD, Approved before 1982 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N012541-002 | DEPO-PROVERA | 100MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N012541-003 | DEPO-PROVERA | 400MG/ML | INJECTABLE / INJECTION | RLD, Approved before 1982 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N012541-002 | DEPO-PROVERA | 100MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N012541-003 | DEPO-PROVERA | 400MG/ML | INJECTABLE / INJECTION | RLD, Approved before 1982 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N012541-002 | DEPO-PROVERA | 100MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N012541-003 | DEPO-PROVERA | 400MG/ML | INJECTABLE / INJECTION | RLD, Approved before 1982 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N012541-002 | DEPO-PROVERA | 100MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N012541-003 | DEPO-PROVERA | 400MG/ML | INJECTABLE / INJECTION | RLD, Approved before 1982 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N012541-002 | DEPO-PROVERA | 100MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N012541-003 | DEPO-PROVERA | 400MG/ML | INJECTABLE / INJECTION | RLD, Approved before 1982 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N012541-002 | DEPO-PROVERA | 100MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N012541-003 | DEPO-PROVERA | 400MG/ML | INJECTABLE / INJECTION | RLD, Approved before 1982 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N012541-002 | DEPO-PROVERA | 100MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N012541-003 | DEPO-PROVERA | 400MG/ML | INJECTABLE / INJECTION | RLD, Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N012541-002 | DEPO-PROVERA | 100MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N012541-003 | DEPO-PROVERA | 400MG/ML | INJECTABLE / INJECTION | RLD, Approved before 1982 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N012541-002 | DEPO-PROVERA | 100MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N012541-003 | DEPO-PROVERA | 400MG/ML | INJECTABLE / INJECTION | RLD, Approved before 1982 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N012541-002 | DEPO-PROVERA | 100MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N012541-003 | DEPO-PROVERA | 400MG/ML | INJECTABLE / INJECTION | RLD, Approved before 1982 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N012541-002 | DEPO-PROVERA | 100MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N012541-003 | DEPO-PROVERA | 400MG/ML | INJECTABLE / INJECTION | RLD, Approved before 1982 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N012541-002 | DEPO-PROVERA | 100MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N012541-003 | DEPO-PROVERA | 400MG/ML | INJECTABLE / INJECTION | RLD, Approved before 1982 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N012541-002 | DEPO-PROVERA | 100MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N012541-003 | DEPO-PROVERA | 400MG/ML | INJECTABLE / INJECTION | RLD, Approved before 1982 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N012541-002 | DEPO-PROVERA | 100MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N012541-003 | DEPO-PROVERA | 400MG/ML | INJECTABLE / INJECTION | RLD, Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N012541-002 | DEPO-PROVERA | 100MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N012541-003 | DEPO-PROVERA | 400MG/ML | INJECTABLE / INJECTION | RLD, Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N012541-002 | DEPO-PROVERA | 100MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N012541-003 | DEPO-PROVERA | 400MG/ML | INJECTABLE / INJECTION | RLD, Approved before 1982 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N012541-002 | DEPO-PROVERA | 100MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N012541-003 | DEPO-PROVERA | 400MG/ML | INJECTABLE / INJECTION | RLD, RS, Approved before 1982 | 74a2ff9319b5… |
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 | A-S Medication Solutions | 788df737-e990-4b5e-accd-af13c3b2bf8b | 2025-06-12 | Boxed warning, Warnings, Adverse reactions | MEDROXYPROGESTERONE ACETATE |
| Medroxyprogesterone Acetate | MEDROXYPROGESTERONE ACETATE | Amneal Pharmaceuticals NY LLC | a80560e1-96dd-4380-b3e1-d52719ccdd4b | 2025-02-07 | Boxed warning, Warnings, Adverse reactions | MEDROXYPROGESTERONE ACETATE |
| Medroxyprogesterone Acetate | MEDROXYPROGESTERONE ACETATE | Coupler LLC | 2cf48919-6de8-d3d0-e063-6394a90ac1bc | 2025-01-30 | Boxed warning, Warnings, Adverse reactions | MEDROXYPROGESTERONE ACETATE |
| Medroxyprogesterone Acetate Injectable Suspension | MEDROXYPROGESTERONE ACETATE | Hikma Pharmaceuticals USA Inc. | 0476eac5-d96c-4910-aa86-1ddeeefefe50 | 2025-01-08 | Boxed warning, Warnings, Adverse reactions | MEDROXYPROGESTERONE ACETATE |
| Medroxyprogesterone Acetate | MEDROXYPROGESTERONE ACETATE | PD-Rx Pharmaceuticals, Inc. | 437edd12-2c08-4df4-8cf7-64c47e4779ac | 2025-01-02 | Boxed warning, Warnings, Adverse reactions | MEDROXYPROGESTERONE ACETATE |
| Medroxyprogesterone Acetate | MEDROXYPROGESTERONE ACETATE | Bryant Ranch Prepack | a36c89b7-9463-4d00-a4d3-021d77090077 | 2024-07-08 | Boxed warning, Warnings, Adverse reactions | MEDROXYPROGESTERONE ACETATE |
| Medroxyprogesterone Acetate | MEDROXYPROGESTERONE ACETATE | Bryant Ranch Prepack | a88b33ff-842b-4a5b-a27e-9c2b9e85a4d7 | 2024-07-08 | Boxed warning, Warnings, Adverse reactions | MEDROXYPROGESTERONE ACETATE |
| Medroxyprogesterone Acetate | MEDROXYPROGESTERONE ACETATE | Bryant Ranch Prepack | bdb89690-ced2-48e1-bb1a-e5eccfeda8eb | 2024-07-08 | Boxed warning, Warnings, Adverse reactions | MEDROXYPROGESTERONE ACETATE |
| Medroxyprogesterone Acetate | MEDROXYPROGESTERONE ACETATE | Bryant Ranch Prepack | d9ad130b-8f9a-4a0f-beb4-b692b6d3c5ca | 2024-07-08 | Boxed warning, Warnings, Adverse reactions | MEDROXYPROGESTERONE ACETATE |
| Medroxyprogesterone Acetate | MEDROXYPROGESTERONE ACETATE | NuCare Pharmaceuticals,Inc. | 5c8ffae3-3b3e-197e-e053-2a91aa0a59e3 | 2024-06-04 | Boxed warning, Warnings, Adverse reactions | MEDROXYPROGESTERONE ACETATE |
| Medroxyprogesterone Acetate | MEDROXYPROGESTERONE ACETATE | Teva Pharmaceuticals USA, Inc. | 9eb200b0-db96-4a51-87ea-04db862978c8 | 2024-03-01 | Boxed warning, Warnings, Adverse reactions | MEDROXYPROGESTERONE ACETATE |
| medroxyprogesterone acetate | MEDROXYPROGESTERONE ACETATE | A-S Medication Solutions | ca344c55-5251-470f-9243-eceb9e496e3e | 2023-10-23 | Boxed warning, Warnings, Adverse reactions | MEDROXYPROGESTERONE ACETATE |
| Medroxyprogesterone Acetate | MEDROXYPROGESTERONE ACETATE | Proficient Rx LP | 0df6fd1e-7d9c-4a38-848c-1e562e211c91 | 2023-02-01 | Boxed warning, Warnings, Adverse reactions | MEDROXYPROGESTERONE ACETATE |
| MEDROXYPROGESTERONE ACETATE | MEDROXYPROGESTERONE ACETATE | Sun Pharmaceutical Industries, Inc. | 01e28bef-9758-40cf-a4ff-86ae9f4f5105 | 2022-12-14 | Boxed warning, Warnings, Adverse reactions | MEDROXYPROGESTERONE ACETATE |
| MEDROXYPROGESTERONE ACETATE | MEDROXYPROGESTERONE ACETATE | Sun Pharmaceutical Industries, Inc. | d1ea4098-6196-421f-b8e1-bcb31a061e04 | 2021-06-29 | Boxed warning, Warnings, Adverse reactions | MEDROXYPROGESTERONE ACETATE |
| Medroxyprogesterone Acetate | MEDROXYPROGESTERONE ACETATE | Mylan Institutional LLC | 60aba812-59eb-4d40-9b6b-d135dca9d36b | 2021-03-12 | Boxed warning, Warnings, Adverse reactions | MEDROXYPROGESTERONE ACETATE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0009-0626 | Depo-Provera | medroxyprogesterone acetate | Pharmacia and Upjohn Company LLC | NDA | Current |