Application 081240
- Type
- ANDA
- Sponsor
- ESI
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CYCRIN | MEDROXYPROGESTERONE ACETATE | TABLET;ORAL | 5MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A081240-001 | CYCRIN | MEDROXYPROGESTERONE ACETATE | 5MG | TABLET / ORAL | 1992-10-30 |
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 | A081240-001 | CYCRIN | 5MG | TABLET / ORAL | 1992-10-30 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A081240-001 | CYCRIN | 5MG | TABLET / ORAL | 1992-10-30 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A081240-001 | CYCRIN | 5MG | TABLET / ORAL | 1992-10-30 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A081240-001 | CYCRIN | 5MG | TABLET / ORAL | 1992-10-30 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A081240-001 | CYCRIN | 5MG | TABLET / ORAL | 1992-10-30 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A081240-001 | CYCRIN | 5MG | TABLET / ORAL | 1992-10-30 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A081240-001 | CYCRIN | 5MG | TABLET / ORAL | 1992-10-30 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A081240-001 | CYCRIN | 5MG | TABLET / ORAL | 1992-10-30 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A081240-001 | CYCRIN | 5MG | TABLET / ORAL | 1992-10-30 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A081240-001 | CYCRIN | 5MG | TABLET / ORAL | 1992-10-30 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A081240-001 | CYCRIN | 5MG | TABLET / ORAL | 1992-10-30 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A081240-001 | CYCRIN | 5MG | TABLET / ORAL | 1992-10-30 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A081240-001 | CYCRIN | 5MG | TABLET / ORAL | 1992-10-30 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A081240-001 | CYCRIN | 5MG | TABLET / ORAL | 1992-10-30 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A081240-001 | CYCRIN | 5MG | TABLET / ORAL | 1992-10-30 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A081240-001 | CYCRIN | 5MG | TABLET / ORAL | 1992-10-30 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A081240-001 | CYCRIN | 5MG | TABLET / ORAL | 1992-10-30 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A081240-001 | CYCRIN | 5MG | TABLET / ORAL | 1992-10-30 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A081240-001 | CYCRIN | 5MG | TABLET / ORAL | 1992-10-30 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A081240-001 | CYCRIN | 5MG | TABLET / ORAL | 1992-10-30 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A081240-001 | CYCRIN | 5MG | TABLET / ORAL | 1992-10-30 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A081240-001 | CYCRIN | 5MG | TABLET / ORAL | 1992-10-30 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A081240-001 | CYCRIN | 5MG | TABLET / ORAL | 1992-10-30 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A081240-001 | CYCRIN | 5MG | TABLET / ORAL | 1992-10-30 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A081240-001 | CYCRIN | 5MG | TABLET / ORAL | 1992-10-30 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A081240-001 | CYCRIN | 5MG | TABLET / ORAL | 1992-10-30 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A081240-001 | CYCRIN | 5MG | TABLET / ORAL | 1992-10-30 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A081240-001 | CYCRIN | 5MG | TABLET / ORAL | 1992-10-30 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A081240-001 | CYCRIN | 5MG | TABLET / ORAL | 1992-10-30 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A081240-001 | CYCRIN | 5MG | TABLET / ORAL | 1992-10-30 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A081240-001 | CYCRIN | 5MG | TABLET / ORAL | 1992-10-30 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A081240-001 | CYCRIN | 5MG | TABLET / ORAL | 1992-10-30 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A081240-001 | CYCRIN | 5MG | TABLET / ORAL | 1992-10-30 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A081240-001 | CYCRIN | 5MG | TABLET / ORAL | 1992-10-30 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A081240-001 | CYCRIN | 5MG | TABLET / ORAL | 1992-10-30 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A081240-001 | CYCRIN | 5MG | TABLET / ORAL | 1992-10-30 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A081240-001 | CYCRIN | 5MG | TABLET / ORAL | 1992-10-30 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A081240-001 | CYCRIN | 5MG | TABLET / ORAL | 1992-10-30 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A081240-001 | CYCRIN | 5MG | TABLET / ORAL | 1992-10-30 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A081240-001 | CYCRIN | 5MG | TABLET / ORAL | 1992-10-30 | 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 | MEDROXYPROGESTERONE ACETATE |
| Medroxyprogesterone Acetate | MEDROXYPROGESTERONE ACETATE | REMEDYREPACK INC. | e3dfd683-d44e-427b-af06-70b9b698e016 | 2026-07-20 | Boxed warning, Warnings, Adverse reactions | MEDROXYPROGESTERONE ACETATE |
| Provera | MEDROXYPROGESTERONE ACETATE | Pharmacia & Upjohn Company LLC | a586be28-96af-4fed-a13f-9b94fd4c7405 | 2026-06-29 | Boxed warning, Warnings, Adverse reactions | MEDROXYPROGESTERONE ACETATE |
| Medroxyprogesterone Acetate | MEDROXYPROGESTERONE ACETATE | Preferred Pharmaceuticals Inc. | a9e05272-aa4e-4df8-b08b-481abca3e8fd | 2026-06-15 | Boxed warning, Warnings, Adverse reactions | MEDROXYPROGESTERONE ACETATE |
| Medroxyprogesterone Acetate | MEDROXYPROGESTERONE ACETATE | Preferred Pharmaceuticals, Inc. | 37275fd0-eb24-40a4-a93f-b818bb98414e | 2026-06-15 | Boxed warning, Warnings, Adverse reactions | MEDROXYPROGESTERONE ACETATE |
| Medroxyprogesterone Acetate | MEDROXYPROGESTERONE ACETATE | REMEDYREPACK INC. | 1020bb60-4f13-4cd7-aaa1-c556752c84b7 | 2026-05-27 | Warnings, Adverse reactions | MEDROXYPROGESTERONE ACETATE |
| medroxyprogesterone acetate | MEDROXYPROGESTERONE ACETATE | Mylan Pharmaceuticals Inc. | 2627eb11-06bf-4a45-9172-094468e3ca07 | 2026-05-21 | Boxed warning, Warnings, Adverse reactions | MEDROXYPROGESTERONE ACETATE |
| medroxyprogesterone acetate | MEDROXYPROGESTERONE ACETATE | A-S Medication Solutions | 5e817926-ba15-4d16-9463-88f6ff3bd3ac | 2026-02-23 | Boxed warning, Warnings, Adverse reactions | MEDROXYPROGESTERONE ACETATE |
| Medroxyprogesterone Acetate | MEDROXYPROGESTERONE ACETATE | Xiromed LLC | 24544a5d-0cf5-a099-b57c-6e0843a40532 | 2026-02-13 | Boxed warning, Warnings, Adverse reactions | MEDROXYPROGESTERONE ACETATE |
| medroxyprogesterone acetate | MEDROXYPROGESTERONE ACETATE | Amneal Pharmaceuticals LLC | 6457d70a-2f25-4935-8511-726d988f7a03 | 2026-01-19 | Boxed warning, Warnings, Adverse reactions | MEDROXYPROGESTERONE ACETATE |
| MEDROXYPROGESTERONE ACETATE | MEDROXYPROGESTERONE ACETATE | Eugia US LLC | 0655670a-d127-4e08-8a23-ace64b2503b2 | 2026-01-08 | Boxed warning, Warnings, Adverse reactions | MEDROXYPROGESTERONE ACETATE |
| Medroxyprogesterone Acetate | MEDROXYPROGESTERONE ACETATE | A-S Medication Solutions | 816b9fd2-bc55-496b-846a-cabe7bbdecd6 | 2026-01-06 | Boxed warning, Warnings, Adverse reactions | MEDROXYPROGESTERONE ACETATE |
| Medroxyprogesterone Acetate | MEDROXYPROGESTERONE ACETATE | Northwind Health Company, LLC | 0de6142f-a78e-ae58-e063-6394a90adff0 | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | MEDROXYPROGESTERONE ACETATE |
| Medroxyprogesterone Acetate | MEDROXYPROGESTERONE ACETATE | Amphastar Pharmaceuticals, Inc. | fda1aa8a-5739-482a-b4f6-9741ef4d9977 | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | MEDROXYPROGESTERONE ACETATE |
| Depo-Provera | MEDROXYPROGESTERONE ACETATE | Pharmacia & Upjohn Company LLC | 199cf13e-0859-4a73-9b45-e700d0cd1049 | 2025-12-18 | Boxed warning, Warnings, Adverse reactions | MEDROXYPROGESTERONE ACETATE |
| Depo-SubQ Provera | MEDROXYPROGESTERONE ACETATE | Pharmacia & Upjohn Company LLC | 390087a6-f3c3-4f0b-a930-79acf412f153 | 2025-12-18 | Boxed warning, Warnings, Adverse reactions | MEDROXYPROGESTERONE ACETATE |
| Medroxyprogesterone Acetate | MEDROXYPROGESTERONE ACETATE | American Health Packaging | cbf142f9-9af3-4d79-9343-0ab42d6dbe9f | 2025-11-13 | Boxed warning, Warnings, Adverse reactions | MEDROXYPROGESTERONE ACETATE |
| medroxyprogesterone acetate | MEDROXYPROGESTERONE ACETATE | REMEDYREPACK INC. | a0a92717-c1cb-40eb-a95a-1c5dfd32cfc0 | 2025-10-02 | Boxed warning, Warnings, Adverse reactions | MEDROXYPROGESTERONE ACETATE |
| Medroxyprogesterone Acetate | MEDROXYPROGESTERONE ACETATE | PD-Rx Pharmaceuticals, Inc. | 6a541749-5d14-44aa-a409-5e51f5bbf929 | 2025-10-02 | Boxed warning, Warnings, Adverse reactions | MEDROXYPROGESTERONE ACETATE |
| Medroxyprogesterone Acetate | MEDROXYPROGESTERONE ACETATE | A-S Medication Solutions | bfdf335d-1cbb-4533-9fde-99a9c71f7504 | 2025-06-12 | Boxed warning, Warnings, Adverse reactions | MEDROXYPROGESTERONE ACETATE |