Application 091242
- Type
- ANDA
- Sponsor
- IMPAX LABS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ANASTROZOLE | ANASTROZOLE | TABLET;ORAL | 1MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A091242-001 | ANASTROZOLE | ANASTROZOLE | 1MG | TABLET / ORAL | 2012-05-31 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A091242-001 | ANASTROZOLE | 1MG | TABLET / ORAL | 2012-05-31 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091242-001 | ANASTROZOLE | 1MG | TABLET / ORAL | 2012-05-31 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A091242-001 | ANASTROZOLE | 1MG | TABLET / ORAL | 2012-05-31 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091242-001 | ANASTROZOLE | 1MG | TABLET / ORAL | 2012-05-31 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091242-001 | ANASTROZOLE | 1MG | TABLET / ORAL | 2012-05-31 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091242-001 | ANASTROZOLE | 1MG | TABLET / ORAL | 2012-05-31 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091242-001 | ANASTROZOLE | 1MG | TABLET / ORAL | 2012-05-31 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091242-001 | ANASTROZOLE | 1MG | TABLET / ORAL | 2012-05-31 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091242-001 | ANASTROZOLE | 1MG | TABLET / ORAL | 2012-05-31 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A091242-001 | ANASTROZOLE | 1MG | TABLET / ORAL | 2012-05-31 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091242-001 | ANASTROZOLE | 1MG | TABLET / ORAL | 2012-05-31 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091242-001 | ANASTROZOLE | 1MG | TABLET / ORAL | 2012-05-31 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091242-001 | ANASTROZOLE | 1MG | TABLET / ORAL | 2012-05-31 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A091242-001 | ANASTROZOLE | 1MG | TABLET / ORAL | 2012-05-31 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A091242-001 | ANASTROZOLE | 1MG | TABLET / ORAL | 2012-05-31 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A091242-001 | ANASTROZOLE | 1MG | TABLET / ORAL | 2012-05-31 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A091242-001 | ANASTROZOLE | 1MG | TABLET / ORAL | 2012-05-31 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A091242-001 | ANASTROZOLE | 1MG | TABLET / ORAL | 2012-05-31 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A091242-001 | ANASTROZOLE | 1MG | TABLET / ORAL | 2012-05-31 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A091242-001 | ANASTROZOLE | 1MG | TABLET / ORAL | 2012-05-31 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A091242-001 | ANASTROZOLE | 1MG | TABLET / ORAL | 2012-05-31 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A091242-001 | ANASTROZOLE | 1MG | TABLET / ORAL | 2012-05-31 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A091242-001 | ANASTROZOLE | 1MG | TABLET / ORAL | 2012-05-31 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A091242-001 | ANASTROZOLE | 1MG | TABLET / ORAL | 2012-05-31 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A091242-001 | ANASTROZOLE | 1MG | TABLET / ORAL | 2012-05-31 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A091242-001 | ANASTROZOLE | 1MG | TABLET / ORAL | 2012-05-31 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A091242-001 | ANASTROZOLE | 1MG | TABLET / ORAL | 2012-05-31 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A091242-001 | ANASTROZOLE | 1MG | TABLET / ORAL | 2012-05-31 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A091242-001 | ANASTROZOLE | 1MG | TABLET / ORAL | 2012-05-31 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A091242-001 | ANASTROZOLE | 1MG | TABLET / ORAL | 2012-05-31 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A091242-001 | ANASTROZOLE | 1MG | TABLET / ORAL | 2012-05-31 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A091242-001 | ANASTROZOLE | 1MG | TABLET / ORAL | 2012-05-31 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A091242-001 | ANASTROZOLE | 1MG | TABLET / ORAL | 2012-05-31 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A091242-001 | ANASTROZOLE | 1MG | TABLET / ORAL | 2012-05-31 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A091242-001 | ANASTROZOLE | 1MG | TABLET / ORAL | 2012-05-31 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A091242-001 | ANASTROZOLE | 1MG | TABLET / ORAL | 2012-05-31 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A091242-001 | ANASTROZOLE | 1MG | TABLET / ORAL | 2012-05-31 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A091242-001 | ANASTROZOLE | 1MG | TABLET / ORAL | 2012-05-31 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A091242-001 | ANASTROZOLE | 1MG | TABLET / ORAL | 2012-05-31 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A091242-001 | ANASTROZOLE | 1MG | TABLET / ORAL | 2012-05-31 | cb3db0bc1861… |
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 |
|---|---|---|---|---|---|---|
| ANASTROZOLE | ANASTROZOLE | Breckenridge Pharmaceutical, Inc. | ca9d4aff-ffdf-4a46-ad20-e47e5886a19e | 2026-07-09 | Warnings, Adverse reactions | ANASTROZOLE ANASTROZOLE |
| Anastrozole | ANASTROZOLE | PD-Rx Pharmaceuticals, Inc. | aabd8f88-2b52-4d43-8dc6-61605988c4dc | 2026-07-07 | Warnings, Adverse reactions | Anastrozole ANASTROZOLE |
| Anastrozole | ANASTROZOLE | PD-Rx Pharmaceuticals, Inc. | 54da5c12-cfaf-7a14-e063-6394a90a3635 | 2026-06-22 | Warnings, Adverse reactions | Anastrozole ANASTROZOLE |
| Anastrozole | ANASTROZOLE | Bryant Ranch Prepack | f5b53383-0366-4ae2-9aa4-88b56c0bbd07 | 2026-06-18 | Warnings, Adverse reactions | Anastrozole ANASTROZOLE |
| Anastrozole | ANASTROZOLE TABLETS | ASCLEMED USA INC. | 39df1668-8344-4c42-9bd7-7907bd571f6e | 2026-06-15 | Warnings, Adverse reactions | Anastrozole |
| ANASTROZOLE | ANASTROZOLE | NuCare Pharmaceuticals,Inc. | 69be1c52-93db-e2c3-e053-2a91aa0af774 | 2026-05-28 | Warnings, Adverse reactions | ANASTROZOLE ANASTROZOLE |
| Anastrozole | ANASTROZOLE TABLETS | NuCare Pharmaceuticals, Inc. | 513e8413-af48-4acc-e063-6294a90a24b4 | 2026-05-07 | Warnings, Adverse reactions | Anastrozole |
| ANASTROZOLE | ANASTROZOLE | AvPAK | 94a46579-0d79-89c7-e053-2995a90a6467 | 2026-03-10 | Warnings, Adverse reactions | ANASTROZOLE ANASTROZOLE |
| ARIMIDEX | ANASTROZOLE | ANI Pharmaceuticals, Inc. | acbfaaa9-503c-4691-9828-76a7146ed6de | 2026-03-02 | Warnings, Adverse reactions | ANASTROZOLE |
| Anastrozole | ANASTROZOLE | Asclemed USA, Inc. | b964f555-25d2-47ad-8942-f195f062445c | 2026-02-14 | Warnings, Adverse reactions | Anastrozole ANASTROZOLE |
| Anastrozole | ANASTROZOLE | Accord Healthcare Inc. | 03586c40-eb32-45c5-beb7-6762a6b78790 | 2026-02-11 | Warnings, Adverse reactions | Anastrozole ANASTROZOLE |
| Anastrozole | ANASTROZOLE | AvKARE | a0c2672b-e07b-4f6c-e053-2a95a90a2e5d | 2026-01-14 | Warnings, Adverse reactions | Anastrozole ANASTROZOLE |
| ANASTROZOLE | ANASTROZOLE | AvKARE | f40b925f-9f43-321d-e053-2a95a90aca8b | 2026-01-13 | Warnings, Adverse reactions | ANASTROZOLE ANASTROZOLE |
| Anastrozole | ANASTROZOLE TABLETS | Avet Pharmaceuticals Inc | f86d2158-b078-3f74-e053-6394a90aa4b6 | 2025-12-29 | Warnings, Adverse reactions | Anastrozole |
| Anastrozole | ANASTROZOLE TABLETS | Yiling Pharmaceutical, Inc. | 7b3da447-8e7c-2aaa-e053-2a91aa0a2821 | 2025-12-29 | Warnings, Adverse reactions | Anastrozole |
| ANASTROZOLE | ANASTROZOLE | NuCare Pharmaceuticals, Inc. | 362034e9-2830-19a5-e063-6394a90a8dfb | 2025-12-09 | Warnings, Adverse reactions | ANASTROZOLE ANASTROZOLE |
| Anastrozole | ANASTROZOLE | Chartwell RX, LLC | da6ae05c-81e9-492a-a4c9-be3f1f367b59 | 2025-12-09 | Warnings, Adverse reactions | Anastrozole ANASTROZOLE |
| Anastrozole | ANASTROZOLE TABLETS | Proficient Rx LP | 2df2aa01-1fe7-477c-9a23-699879b0b918 | 2025-09-01 | Warnings, Adverse reactions | Anastrozole |
| Anastrozole | ANASTROZOLE | American Health Packaging | dface914-5135-4136-82f4-75429b496a35 | 2025-08-29 | Warnings, Adverse reactions | Anastrozole ANASTROZOLE |
| Anastrozole | ANASTROZOLE TABLETS | Upsher-Smith Laboratories, LLC | 7e0bd2cc-d3cc-403f-a6b6-4597ccb2f685 | 2025-07-09 | Warnings, Adverse reactions | Anastrozole |