Application 088503
- Type
- ANDA
- Sponsor
- FOREST LABS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DURAPHYL | THEOPHYLLINE | TABLET, EXTENDED RELEASE;ORAL | 100MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A088503-001 | DURAPHYL | THEOPHYLLINE | 100MG | TABLET, EXTENDED RELEASE / ORAL | 1985-04-03 |
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 | A088503-001 | DURAPHYL | 100MG | TABLET, EXTENDED RELEASE / ORAL | 1985-04-03 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A088503-001 | DURAPHYL | 100MG | TABLET, EXTENDED RELEASE / ORAL | 1985-04-03 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A088503-001 | DURAPHYL | 100MG | TABLET, EXTENDED RELEASE / ORAL | 1985-04-03 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A088503-001 | DURAPHYL | 100MG | TABLET, EXTENDED RELEASE / ORAL | 1985-04-03 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A088503-001 | DURAPHYL | 100MG | TABLET, EXTENDED RELEASE / ORAL | 1985-04-03 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A088503-001 | DURAPHYL | 100MG | TABLET, EXTENDED RELEASE / ORAL | 1985-04-03 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A088503-001 | DURAPHYL | 100MG | TABLET, EXTENDED RELEASE / ORAL | 1985-04-03 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A088503-001 | DURAPHYL | 100MG | TABLET, EXTENDED RELEASE / ORAL | 1985-04-03 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A088503-001 | DURAPHYL | 100MG | TABLET, EXTENDED RELEASE / ORAL | 1985-04-03 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A088503-001 | DURAPHYL | 100MG | TABLET, EXTENDED RELEASE / ORAL | 1985-04-03 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A088503-001 | DURAPHYL | 100MG | TABLET, EXTENDED RELEASE / ORAL | 1985-04-03 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A088503-001 | DURAPHYL | 100MG | TABLET, EXTENDED RELEASE / ORAL | 1985-04-03 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A088503-001 | DURAPHYL | 100MG | TABLET, EXTENDED RELEASE / ORAL | 1985-04-03 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A088503-001 | DURAPHYL | 100MG | TABLET, EXTENDED RELEASE / ORAL | 1985-04-03 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A088503-001 | DURAPHYL | 100MG | TABLET, EXTENDED RELEASE / ORAL | 1985-04-03 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A088503-001 | DURAPHYL | 100MG | TABLET, EXTENDED RELEASE / ORAL | 1985-04-03 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A088503-001 | DURAPHYL | 100MG | TABLET, EXTENDED RELEASE / ORAL | 1985-04-03 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A088503-001 | DURAPHYL | 100MG | TABLET, EXTENDED RELEASE / ORAL | 1985-04-03 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A088503-001 | DURAPHYL | 100MG | TABLET, EXTENDED RELEASE / ORAL | 1985-04-03 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A088503-001 | DURAPHYL | 100MG | TABLET, EXTENDED RELEASE / ORAL | 1985-04-03 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A088503-001 | DURAPHYL | 100MG | TABLET, EXTENDED RELEASE / ORAL | 1985-04-03 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A088503-001 | DURAPHYL | 100MG | TABLET, EXTENDED RELEASE / ORAL | 1985-04-03 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A088503-001 | DURAPHYL | 100MG | TABLET, EXTENDED RELEASE / ORAL | 1985-04-03 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A088503-001 | DURAPHYL | 100MG | TABLET, EXTENDED RELEASE / ORAL | 1985-04-03 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A088503-001 | DURAPHYL | 100MG | TABLET, EXTENDED RELEASE / ORAL | 1985-04-03 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A088503-001 | DURAPHYL | 100MG | TABLET, EXTENDED RELEASE / ORAL | 1985-04-03 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A088503-001 | DURAPHYL | 100MG | TABLET, EXTENDED RELEASE / ORAL | 1985-04-03 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A088503-001 | DURAPHYL | 100MG | TABLET, EXTENDED RELEASE / ORAL | 1985-04-03 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A088503-001 | DURAPHYL | 100MG | TABLET, EXTENDED RELEASE / ORAL | 1985-04-03 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A088503-001 | DURAPHYL | 100MG | TABLET, EXTENDED RELEASE / ORAL | 1985-04-03 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A088503-001 | DURAPHYL | 100MG | TABLET, EXTENDED RELEASE / ORAL | 1985-04-03 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A088503-001 | DURAPHYL | 100MG | TABLET, EXTENDED RELEASE / ORAL | 1985-04-03 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A088503-001 | DURAPHYL | 100MG | TABLET, EXTENDED RELEASE / ORAL | 1985-04-03 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A088503-001 | DURAPHYL | 100MG | TABLET, EXTENDED RELEASE / ORAL | 1985-04-03 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A088503-001 | DURAPHYL | 100MG | TABLET, EXTENDED RELEASE / ORAL | 1985-04-03 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A088503-001 | DURAPHYL | 100MG | TABLET, EXTENDED RELEASE / ORAL | 1985-04-03 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A088503-001 | DURAPHYL | 100MG | TABLET, EXTENDED RELEASE / ORAL | 1985-04-03 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A088503-001 | DURAPHYL | 100MG | TABLET, EXTENDED RELEASE / ORAL | 1985-04-03 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A088503-001 | DURAPHYL | 100MG | TABLET, EXTENDED RELEASE / ORAL | 1985-04-03 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A088503-001 | DURAPHYL | 100MG | TABLET, EXTENDED RELEASE / ORAL | 1985-04-03 | 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 |
|---|---|---|---|---|---|---|
| Theophylline | THEOPHYLLINE | PD-Rx Pharmaceuticals, Inc. | c6ca5cc9-4e5e-40cf-a36e-227aa4cb55c6 | 2026-07-29 | Warnings, Adverse reactions | THEOPHYLLINE |
| Theophylline | THEOPHYLLINE | PD-Rx Pharmaceuticals, Inc. | 5e64036a-ee3e-42e7-9e59-881f88a4e298 | 2026-07-29 | Warnings, Adverse reactions | THEOPHYLLINE |
| Theophylline (Anhydrous) | THEOPHYLLINE | Golden State Medical Supply, Inc. | aa80b9f4-8a5d-3e14-e053-2a95a90a8aab | 2026-05-27 | Warnings, Adverse reactions | THEOPHYLLINE |
| theophylline | THEOPHYLLINE | Amneal Pharmaceuticals NY LLC | b0d5d1cd-c79b-4229-929c-2eb3e4f43298 | 2026-04-27 | Warnings, Adverse reactions | THEOPHYLLINE |
| Theophylline | THEOPHYLLINE | Strides Pharma Science Limited | b7a90ccf-9c32-40cc-9008-7e55b3da4dfd | 2026-03-10 | Warnings, Adverse reactions | THEOPHYLLINE |
| Theophylline | THEOPHYLLINE | Chartwell RX, LLC | 1b685384-5d96-46fa-b93b-e96538a2cfe7 | 2026-02-06 | Warnings, Adverse reactions | THEOPHYLLINE |
| Theophylline | THEOPHYLLINE | Glenmark Pharmaceuticals Inc., USA | 48330a8e-be08-4d38-b8b1-d30fbd5a35de | 2026-01-29 | Warnings, Adverse reactions | THEOPHYLLINE |
| Theophylline | THEOPHYLLINE | Glenmark Pharmaceuticals Inc., USA | 56fc2167-ceb6-4e3e-8ff7-5e400dfbd533 | 2026-01-29 | Warnings, Adverse reactions | THEOPHYLLINE |
| Theophylline | THEOPHYLLINE | AvKARE | f93e20b1-97aa-088d-e053-6394a90a25d4 | 2026-01-19 | Warnings, Adverse reactions | THEOPHYLLINE |
| Theophylline | THEOPHYLLINE | Chartwell RX, LLC | 9591d4db-2b88-4f0f-b61e-64ba67626e3d | 2025-12-10 | Warnings, Adverse reactions | THEOPHYLLINE |
| Theophylline | THEOPHYLLINE | ATLANTIC BIOLOGICALS CORP. | 47e484c2-f59e-4a71-bb97-c90f128ac345 | 2025-12-04 | Warnings, Adverse reactions | THEOPHYLLINE |
| Theophylline | THEOPHYLLINE | Ajanta Pharma USA Inc. | 7a422c32-bbdf-4297-84f4-9c438c904b0c | 2025-11-30 | Warnings, Adverse reactions | THEOPHYLLINE |
| Theophylline | THEOPHYLLINE | Chartwell Governmental & Specialty RX, LLC. | e2716dac-8b23-4e06-bc3e-4dd76b7c813e | 2025-11-14 | Warnings, Adverse reactions | THEOPHYLLINE |
| Theophylline | THEOPHYLLINE | Bryant Ranch Prepack | 62fb84a9-4e75-4f4b-8f15-1fd1bb7ae4dd | 2025-10-22 | Warnings, Adverse reactions | THEOPHYLLINE |
| Theophylline | THEOPHYLLINE | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 701fbf9c-e06b-46f4-863b-981acf3021aa | 2025-07-10 | Warnings, Adverse reactions | THEOPHYLLINE |
| Theophylline | THEOPHYLLINE | Bryant Ranch Prepack | 955dba5e-c3b7-4a45-8650-e1b4722dbaea | 2024-11-20 | Warnings, Adverse reactions | THEOPHYLLINE |
| THEOPHYLLINE | THEOPHYLLINE | PAI Holdings, LLC dba PAI Pharma | 32b9780f-c46f-4e0f-9641-2cab60600e6e | 2024-11-19 | Warnings, Adverse reactions | THEOPHYLLINE |
| THEOPHYLLINE | THEOPHYLLINE | Leading Pharma, LLC | ac490ebf-24e1-47c4-a932-ad4dcafe7aad | 2024-10-07 | Warnings, Adverse reactions | THEOPHYLLINE |
| Theophylline | THEOPHYLLINE | Cranbury Pharmaceuticals, LLC | 78a99bfe-6ebe-4ace-80b0-ee019921435e | 2024-08-30 | Warnings, Adverse reactions | THEOPHYLLINE |
| Theophylline | THEOPHYLLINE | Viona Pharmaceuticals Inc | abdfb9b9-9402-4761-9347-8eb1c4d86242 | 2024-05-22 | Warnings, Adverse reactions | THEOPHYLLINE |