Application 076553
- Type
- ANDA
- Sponsor
- TEVA PHARMS USA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | MEDROXYPROGESTERONE ACETATE | MEDROXYPROGESTERONE ACETATE | INJECTABLE;INJECTION | 150MG/ML | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A076553-001 | MEDROXYPROGESTERONE ACETATE | MEDROXYPROGESTERONE ACETATE | 150MG/ML | INJECTABLE / INJECTION | AB | 2004-07-28 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A076553-001 | 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 | A076553-001 | MEDROXYPROGESTERONE ACETATE | 150MG/ML | INJECTABLE / INJECTION | AB | 2004-07-28 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076553-001 | MEDROXYPROGESTERONE ACETATE | 150MG/ML | INJECTABLE / INJECTION | AB | 2004-07-28 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076553-001 | MEDROXYPROGESTERONE ACETATE | 150MG/ML | INJECTABLE / INJECTION | AB | 2004-07-28 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076553-001 | MEDROXYPROGESTERONE ACETATE | 150MG/ML | INJECTABLE / INJECTION | AB | 2004-07-28 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076553-001 | MEDROXYPROGESTERONE ACETATE | 150MG/ML | INJECTABLE / INJECTION | AB | 2004-07-28 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076553-001 | MEDROXYPROGESTERONE ACETATE | 150MG/ML | INJECTABLE / INJECTION | AB | 2004-07-28 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076553-001 | MEDROXYPROGESTERONE ACETATE | 150MG/ML | INJECTABLE / INJECTION | AB | 2004-07-28 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076553-001 | MEDROXYPROGESTERONE ACETATE | 150MG/ML | INJECTABLE / INJECTION | AB | 2004-07-28 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076553-001 | MEDROXYPROGESTERONE ACETATE | 150MG/ML | INJECTABLE / INJECTION | AB | 2004-07-28 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076553-001 | MEDROXYPROGESTERONE ACETATE | 150MG/ML | INJECTABLE / INJECTION | AB | 2004-07-28 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A076553-001 | MEDROXYPROGESTERONE ACETATE | 150MG/ML | INJECTABLE / INJECTION | AB | 2004-07-28 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076553-001 | MEDROXYPROGESTERONE ACETATE | 150MG/ML | INJECTABLE / INJECTION | AB | 2004-07-28 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076553-001 | MEDROXYPROGESTERONE ACETATE | 150MG/ML | INJECTABLE / INJECTION | AB | 2004-07-28 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076553-001 | MEDROXYPROGESTERONE ACETATE | 150MG/ML | INJECTABLE / INJECTION | AB | 2004-07-28 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A076553-001 | MEDROXYPROGESTERONE ACETATE | 150MG/ML | INJECTABLE / INJECTION | AB | 2004-07-28 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A076553-001 | MEDROXYPROGESTERONE ACETATE | 150MG/ML | INJECTABLE / INJECTION | AB | 2004-07-28 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A076553-001 | MEDROXYPROGESTERONE ACETATE | 150MG/ML | INJECTABLE / INJECTION | AB | 2004-07-28 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A076553-001 | MEDROXYPROGESTERONE ACETATE | 150MG/ML | INJECTABLE / INJECTION | AB | 2004-07-28 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A076553-001 | MEDROXYPROGESTERONE ACETATE | 150MG/ML | INJECTABLE / INJECTION | AB | 2004-07-28 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A076553-001 | MEDROXYPROGESTERONE ACETATE | 150MG/ML | INJECTABLE / INJECTION | AB | 2004-07-28 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A076553-001 | MEDROXYPROGESTERONE ACETATE | 150MG/ML | INJECTABLE / INJECTION | AB | 2004-07-28 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A076553-001 | MEDROXYPROGESTERONE ACETATE | 150MG/ML | INJECTABLE / INJECTION | AB | 2004-07-28 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A076553-001 | MEDROXYPROGESTERONE ACETATE | 150MG/ML | INJECTABLE / INJECTION | AB | 2004-07-28 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A076553-001 | MEDROXYPROGESTERONE ACETATE | 150MG/ML | INJECTABLE / INJECTION | AB | 2004-07-28 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A076553-001 | MEDROXYPROGESTERONE ACETATE | 150MG/ML | INJECTABLE / INJECTION | AB | 2004-07-28 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A076553-001 | MEDROXYPROGESTERONE ACETATE | 150MG/ML | INJECTABLE / INJECTION | AB | 2004-07-28 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A076553-001 | MEDROXYPROGESTERONE ACETATE | 150MG/ML | INJECTABLE / INJECTION | AB | 2004-07-28 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A076553-001 | MEDROXYPROGESTERONE ACETATE | 150MG/ML | INJECTABLE / INJECTION | AB | 2004-07-28 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A076553-001 | MEDROXYPROGESTERONE ACETATE | 150MG/ML | INJECTABLE / INJECTION | AB | 2004-07-28 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A076553-001 | MEDROXYPROGESTERONE ACETATE | 150MG/ML | INJECTABLE / INJECTION | AB | 2004-07-28 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A076553-001 | MEDROXYPROGESTERONE ACETATE | 150MG/ML | INJECTABLE / INJECTION | AB | 2004-07-28 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A076553-001 | MEDROXYPROGESTERONE ACETATE | 150MG/ML | INJECTABLE / INJECTION | AB | 2004-07-28 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A076553-001 | MEDROXYPROGESTERONE ACETATE | 150MG/ML | INJECTABLE / INJECTION | AB | 2004-07-28 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A076553-001 | MEDROXYPROGESTERONE ACETATE | 150MG/ML | INJECTABLE / INJECTION | AB | 2004-07-28 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A076553-001 | MEDROXYPROGESTERONE ACETATE | 150MG/ML | INJECTABLE / INJECTION | AB | 2004-07-28 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A076553-001 | MEDROXYPROGESTERONE ACETATE | 150MG/ML | INJECTABLE / INJECTION | AB | 2004-07-28 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A076553-001 | MEDROXYPROGESTERONE ACETATE | 150MG/ML | INJECTABLE / INJECTION | AB | 2004-07-28 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A076553-001 | MEDROXYPROGESTERONE ACETATE | 150MG/ML | INJECTABLE / INJECTION | AB | 2004-07-28 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A076553-001 | MEDROXYPROGESTERONE ACETATE | 150MG/ML | INJECTABLE / INJECTION | AB | 2004-07-28 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | A076553-001 | MEDROXYPROGESTERONE ACETATE | 150MG/ML | INJECTABLE / INJECTION | AB | 2004-07-28 | 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 | A076553-001 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A076553-001 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076553-001 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A076553-001 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076553-001 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076553-001 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076553-001 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076553-001 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076553-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076553-001 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A076553-001 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076553-001 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076553-001 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076553-001 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A076553-001 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A076553-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A076553-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A076553-001 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A076553-001 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A076553-001 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A076553-001 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A076553-001 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A076553-001 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A076553-001 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A076553-001 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A076553-001 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A076553-001 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A076553-001 | AB | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A076553-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A076553-001 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A076553-001 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A076553-001 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A076553-001 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A076553-001 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A076553-001 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A076553-001 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A076553-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A076553-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A076553-001 | AB | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A076553-001 | 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.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0703-6801 | Medroxyprogesterone Acetate | Medroxyprogesterone Acetate | Teva Parenteral Medicines, Inc. | ANDA | Current |
| 0703-6801 | Medroxyprogesterone Acetate | Medroxyprogesterone Acetate | Teva Parenteral Medicines, Inc. | ANDA | Current |
| 0703-6801 | Medroxyprogesterone Acetate | Medroxyprogesterone Acetate | Teva Parenteral Medicines, Inc. | ANDA | Current |
| 0703-6801 | Medroxyprogesterone Acetate | Medroxyprogesterone Acetate | Teva Parenteral Medicines, Inc. | ANDA | Current |
| 0703-6801 | Medroxyprogesterone Acetate | Medroxyprogesterone Acetate | Teva Parenteral Medicines, Inc. | ANDA | Current |
| 0703-6801 | Medroxyprogesterone Acetate | Medroxyprogesterone Acetate | Teva Parenteral Medicines, Inc. | ANDA | Current |
| 16714-028 | Medroxyprogesterone Acetate | Medroxyprogesterone Acetate | Northstar RxLLC | ANDA | Current |
| 16714-028 | Medroxyprogesterone Acetate | Medroxyprogesterone Acetate | Northstar RxLLC | ANDA | Current |
| 63629-8744 | Medroxyprogesterone Acetate | Medroxyprogesterone Acetate | Bryant Ranch Prepack | ANDA | Current |
| 63629-8744 | Medroxyprogesterone Acetate | Medroxyprogesterone Acetate | Bryant Ranch Prepack | ANDA | Current |
| 68071-1818 | Medroxyprogesterone Acetate | Medroxyprogesterone Acetate | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 71205-118 | Medroxyprogesterone Acetate | Medroxyprogesterone Acetate | Proficient Rx LP | ANDA | Current |
| 71205-118 | Medroxyprogesterone Acetate | Medroxyprogesterone Acetate | Proficient Rx LP | ANDA | Current |