Application 204236
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | NORETHINDRONE ACETATE | NORETHINDRONE ACETATE | TABLET;ORAL | 5MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A204236-001 | NORETHINDRONE ACETATE | NORETHINDRONE ACETATE | 5MG | TABLET / ORAL | 2016-01-08 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2022-10-28 04:53 UTC | 2022-10 | A204236-001 | NORETHINDRONE ACETATE | 5MG | TABLET / ORAL | 2016-01-08 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A204236-001 | NORETHINDRONE ACETATE | 5MG | TABLET / ORAL | 2016-01-08 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A204236-001 | NORETHINDRONE ACETATE | 5MG | TABLET / ORAL | 2016-01-08 | cb3db0bc1861… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A204236-001 | NORETHINDRONE ACETATE | 5MG | TABLET / ORAL | 2016-01-08 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-09-15 20:21 UTC | 2019-09 | A204236-001 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A204236-001 | AB | 1 | ea99ee380514… |
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 |
|---|---|---|---|---|---|---|
| Norethindrone Acetate | NORETHINDRONE ACETATE | Glenmark Pharmaceuticals Inc., USA | d0a94321-eb60-4aa6-a429-f0156f9f8e01 | 2026-01-29 | Warnings, Adverse reactions | Norethindrone Acetate NORETHINDRONE ACETATE |
| Norethindrone Acetate | NORETHINDRONE ACETATE | American Health Packaging | eb0b80e0-5b69-4efa-ae8a-62e718a62dc3 | 2026-01-14 | Warnings, Adverse reactions | Norethindrone Acetate NORETHINDRONE ACETATE |
| Norethindrone Acetate | NORETHINDRONE | AvKARE | 827c7ef1-a8b7-d0c4-b062-c5154b331a35 | 2025-09-17 | Warnings, Adverse reactions | Norethindrone Acetate |
| Norethindrone Acetate | NORETHINDRONE ACETATE | Golden State Medical Supply, Inc. | 2bb29135-6e9b-a9e2-e063-6394a90ae9e4 | 2025-01-14 | Warnings, Adverse reactions | Norethindrone Acetate NORETHINDRONE ACETATE |
| Norethindrone Acetate | NORETHINDRONE | Amneal Pharmaceuticals LLC | 64cb920c-36e8-4d62-9d08-3ddf3989d313 | 2024-10-30 | Warnings, Adverse reactions | Norethindrone Acetate |
| Gallifrey | NORETHINDRONE ACETATE | Xiromed LLC | 26130af6-221b-2349-81b6-0c0132d6e524 | 2024-08-31 | Warnings, Adverse reactions | NORETHINDRONE ACETATE |
| Norethindrone acetate | NORETHINDRONE ACETATE | Ingenus Pharmaceuticals, LLC | 2f39b608-cc62-4ff0-a52a-bc3343275269 | 2023-12-04 | Warnings, Adverse reactions | Norethindrone acetate NORETHINDRONE ACETATE |
| Norethindrone Acetate | NORETHINDRONE ACETATE | Teva Pharmaceuticals USA, Inc. | f73f9807-4af6-4faa-ba9a-656a47a4c5e0 | 2022-11-30 | Warnings, Adverse reactions | Norethindrone Acetate NORETHINDRONE ACETATE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.