Application 209306
- Type
- ANDA
- Sponsor
- LUPIN LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | GABAPENTIN | GABAPENTIN | TABLET;ORAL | 600MG | No | No |
| 002 | GABAPENTIN | GABAPENTIN | TABLET;ORAL | 800MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A209306-001 | GABAPENTIN | GABAPENTIN | 600MG | TABLET / ORAL | 2018-08-24 | ||
| A209306-002 | GABAPENTIN | GABAPENTIN | 800MG | TABLET / ORAL | 2018-08-24 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A209306-001 | GABAPENTIN | 600MG | TABLET / ORAL | 2018-08-24 | c2088c7a36db… | ||
| 2026-10-15 13:18:30 | 2026-09 | A209306-002 | GABAPENTIN | 800MG | TABLET / ORAL | 2018-08-24 | c2088c7a36db… | ||
| 2026-09-14 22:38:34 | 2026-08 | A209306-001 | GABAPENTIN | 600MG | TABLET / ORAL | 2018-08-24 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A209306-002 | GABAPENTIN | 800MG | TABLET / ORAL | 2018-08-24 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A209306-001 | GABAPENTIN | 600MG | TABLET / ORAL | 2018-08-24 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A209306-002 | GABAPENTIN | 800MG | TABLET / ORAL | 2018-08-24 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A209306-001 | GABAPENTIN | 600MG | TABLET / ORAL | 2018-08-24 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A209306-002 | GABAPENTIN | 800MG | TABLET / ORAL | 2018-08-24 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209306-001 | GABAPENTIN | 600MG | TABLET / ORAL | 2018-08-24 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209306-002 | GABAPENTIN | 800MG | TABLET / ORAL | 2018-08-24 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A209306-001 | GABAPENTIN | 600MG | TABLET / ORAL | 2018-08-24 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A209306-002 | GABAPENTIN | 800MG | TABLET / ORAL | 2018-08-24 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209306-001 | GABAPENTIN | 600MG | TABLET / ORAL | 2018-08-24 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209306-002 | GABAPENTIN | 800MG | TABLET / ORAL | 2018-08-24 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209306-001 | GABAPENTIN | 600MG | TABLET / ORAL | 2018-08-24 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209306-002 | GABAPENTIN | 800MG | TABLET / ORAL | 2018-08-24 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209306-001 | GABAPENTIN | 600MG | TABLET / ORAL | 2018-08-24 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209306-002 | GABAPENTIN | 800MG | TABLET / ORAL | 2018-08-24 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209306-001 | GABAPENTIN | 600MG | TABLET / ORAL | 2018-08-24 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209306-002 | GABAPENTIN | 800MG | TABLET / ORAL | 2018-08-24 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209306-001 | GABAPENTIN | 600MG | TABLET / ORAL | 2018-08-24 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209306-002 | GABAPENTIN | 800MG | TABLET / ORAL | 2018-08-24 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209306-001 | GABAPENTIN | 600MG | TABLET / ORAL | 2018-08-24 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209306-002 | GABAPENTIN | 800MG | TABLET / ORAL | 2018-08-24 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A209306-001 | GABAPENTIN | 600MG | TABLET / ORAL | 2018-08-24 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A209306-002 | GABAPENTIN | 800MG | TABLET / ORAL | 2018-08-24 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A209306-001 | GABAPENTIN | 600MG | TABLET / ORAL | 2018-08-24 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A209306-002 | GABAPENTIN | 800MG | TABLET / ORAL | 2018-08-24 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A209306-001 | GABAPENTIN | 600MG | TABLET / ORAL | 2018-08-24 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A209306-002 | GABAPENTIN | 800MG | TABLET / ORAL | 2018-08-24 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A209306-001 | GABAPENTIN | 600MG | TABLET / ORAL | 2018-08-24 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A209306-002 | GABAPENTIN | 800MG | TABLET / ORAL | 2018-08-24 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A209306-001 | GABAPENTIN | 600MG | TABLET / ORAL | 2018-08-24 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A209306-002 | GABAPENTIN | 800MG | TABLET / ORAL | 2018-08-24 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A209306-001 | GABAPENTIN | 600MG | TABLET / ORAL | 2018-08-24 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A209306-002 | GABAPENTIN | 800MG | TABLET / ORAL | 2018-08-24 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A209306-001 | GABAPENTIN | 600MG | TABLET / ORAL | 2018-08-24 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A209306-002 | GABAPENTIN | 800MG | TABLET / ORAL | 2018-08-24 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A209306-001 | GABAPENTIN | 600MG | TABLET / ORAL | 2018-08-24 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A209306-002 | GABAPENTIN | 800MG | TABLET / ORAL | 2018-08-24 | 4b0b4de00fa7… |
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 |
|---|---|---|---|---|---|---|
| Gabapentin | GABAPENTIN | Bryant Ranch Prepack | be9a572d-e98a-41c1-83c5-859d9176dd1c | 2025-10-03 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| Gabapentin | GABAPENTIN | Bryant Ranch Prepack | eaf5e41e-8ed3-404e-84e0-392bebdbc0b7 | 2025-10-03 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| GABAPENTIN | GABAPENTIN | Proficient Rx LP | da8438e1-755b-4195-baa7-464f3d9ee5bd | 2025-10-01 | Warnings, Adverse reactions | GABAPENTIN GABAPENTIN |
| Gabapentin | GABAPENTIN | Bryant Ranch Prepack | 8f982b95-4e84-4e0c-a543-747bc3dd7531 | 2025-09-26 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| Gabapentin | GABAPENTIN | Bryant Ranch Prepack | d0510d04-460c-47d1-be72-0ee32c4ac640 | 2025-09-26 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| Gabapentin | GABAPENTIN | Bryant Ranch Prepack | 344d67fa-092e-4e71-b96a-25c71bfa6bb1 | 2025-09-25 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| Gabapentin | GABAPENTIN | Bryant Ranch Prepack | bc1316b6-1fc4-4990-95a8-489881772876 | 2025-09-25 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| Gabapentin | GABAPENTIN | Kesin Pharma Corporation | 3f2ba3d6-6086-eaf2-e063-6294a90a7642 | 2025-09-19 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| gabapentin | GABAPENTIN | Coupler LLC | 3eeda97d-c3cd-65cd-e063-6394a90aae8b | 2025-09-16 | Warnings, Adverse reactions | gabapentin GABAPENTIN |
| gabapentin | GABAPENTIN | Zydus Lifesciences Limited | 8c0eeefc-ef5b-49f4-8411-ddbae312ed05 | 2025-09-15 | gabapentin GABAPENTIN | |
| GABAPENTIN | GABAPENTIN | MARKSANS PHARMA LIMITED | 98bb408d-c402-4da6-8f9d-5de4833dedc4 | 2025-09-12 | Warnings, Adverse reactions | GABAPENTIN GABAPENTIN |
| Gabapentin | GABAPENTIN | Epic Pharma, LLC | d592d828-8df1-480d-b179-bb9260a9c824 | 2025-09-12 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| Gabapentin | GABAPENTIN | Zydus Pharmaceuticals USA Inc. | 310ce005-5a24-489a-b23c-d42ab6a3bfed | 2025-09-08 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| gabapentin | GABAPENTIN | Zydus Pharmaceuticals USA Inc. | 3cfd04ab-e421-441f-a10e-e4dd1412974d | 2025-09-05 | Warnings, Adverse reactions | gabapentin GABAPENTIN |
| Gabapentin | GABAPENTIN | Rising Pharma Holdings, Inc. | b1a9808d-31a5-4b63-afd0-d96d5a0ad7a1 | 2025-09-03 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| Gabapentin | GABAPENTIN | Mullan Pharmaceutical Inc. | 74474aa4-4859-42d2-92d8-f23f18b34e04 | 2025-08-21 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| Gabapentin | GABAPENTIN | Direct_Rx | 2cb1ad6d-d389-4564-e063-6394a90a3644 | 2025-08-19 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| Gabapentin | GABAPENTIN | Bryant Ranch Prepack | 137b2b9a-9d42-48d0-913f-5dc146fb689a | 2025-08-19 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| Gabapentin | GABAPENTIN | PD-Rx Pharmaceuticals, Inc. | b4c7388a-19d9-4e3a-83c9-4943fb855be4 | 2025-08-18 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| GABAPENTIN | GABAPENTIN | Camber Pharmaceuticals, Inc. | 9ead7825-d11b-4e00-8533-328d097b8f83 | 2025-08-16 | Warnings, Adverse reactions | GABAPENTIN GABAPENTIN |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.