Application 208928
- Type
- ANDA
- Sponsor
- IPCA LABS LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | GABAPENTIN | GABAPENTIN | CAPSULE;ORAL | 100MG | No | No |
| 002 | GABAPENTIN | GABAPENTIN | CAPSULE;ORAL | 300MG | No | No |
| 003 | GABAPENTIN | GABAPENTIN | CAPSULE;ORAL | 400MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A208928-001 | GABAPENTIN | GABAPENTIN | 100MG | CAPSULE / ORAL | 2023-11-20 | ||
| A208928-002 | GABAPENTIN | GABAPENTIN | 300MG | CAPSULE / ORAL | 2023-11-20 | ||
| A208928-003 | GABAPENTIN | GABAPENTIN | 400MG | CAPSULE / ORAL | 2023-11-20 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A208928-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | 2023-11-20 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A208928-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | 2023-11-20 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A208928-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | 2023-11-20 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A208928-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | 2023-11-20 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A208928-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | 2023-11-20 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A208928-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | 2023-11-20 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A208928-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | 2023-11-20 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A208928-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | 2023-11-20 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A208928-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | 2023-11-20 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208928-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | 2023-11-20 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208928-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | 2023-11-20 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208928-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | 2023-11-20 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A208928-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | 2023-11-20 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A208928-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | 2023-11-20 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A208928-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | 2023-11-20 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208928-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | 2023-11-20 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208928-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | 2023-11-20 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208928-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | 2023-11-20 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208928-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | 2023-11-20 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208928-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | 2023-11-20 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208928-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | 2023-11-20 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208928-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | 2023-11-20 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208928-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | 2023-11-20 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208928-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | 2023-11-20 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208928-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2023-11-20 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208928-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2023-11-20 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208928-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2023-11-20 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208928-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2023-11-20 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208928-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2023-11-20 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208928-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2023-11-20 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A208928-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2023-11-20 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A208928-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2023-11-20 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A208928-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2023-11-20 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A208928-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2023-11-20 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A208928-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2023-11-20 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A208928-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2023-11-20 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A208928-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2023-11-20 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A208928-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2023-11-20 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A208928-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2023-11-20 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A208928-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2023-11-20 | 301d65b070ca… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208928-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208928-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208928-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208928-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208928-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208928-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A208928-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A208928-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A208928-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A208928-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A208928-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A208928-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A208928-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A208928-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A208928-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A208928-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A208928-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A208928-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A208928-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A208928-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A208928-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A208928-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A208928-002 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A208928-003 | AB | 1 | 8072bd15b7f6… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A208928-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A208928-002 | AB | 1 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A208928-003 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A208928-001 | AB | 1 | 1c564ffb4f44… |
| 2024-02-18 07:12 UTC | 2024-02 | A208928-002 | AB | 1 | 1c564ffb4f44… |
| 2024-02-18 07:12 UTC | 2024-02 | A208928-003 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A208928-001 | AB | 1 | ea1830bbd6c7… |
| 2023-12-20 04:57 UTC | 2023-12 | A208928-002 | AB | 1 | ea1830bbd6c7… |
| 2023-12-20 04:57 UTC | 2023-12 | A208928-003 | AB | 1 | ea1830bbd6c7… |
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 |
|---|---|---|---|---|---|---|
| GABARONE | GABAPENTIN | INA Pharmaceutics Inc. | 0f350a4b-f294-4b98-b69f-3cc789e930ba | 2026-01-07 | Warnings, Adverse reactions | GABAPENTIN |
| Gabapentin | GABAPENTIN | Ajenat Pharmaceuticals LLC | 02304deb-7b4a-452f-9b1a-64ca0aedbcc2 | 2025-12-29 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| gabapentin | GABAPENTIN | Northwind Health Company, LLC | 471b2d32-0cbd-aade-e063-6394a90a1696 | 2025-12-29 | Warnings, Adverse reactions | gabapentin GABAPENTIN |
| GABAPENTIN | GABAPENTIN | ST. MARY'S MEDICAL PARK PHARMACY | 3aaf3d6e-c6d5-89f5-e063-6394a90a9b77 | 2025-12-29 | Warnings, Adverse reactions | GABAPENTIN GABAPENTIN |
| GABAPENTIN | GABAPENTIN | Northwind Health Company, LLC | 47214c7c-ba1b-9107-e063-6294a90a5431 | 2025-12-29 | Warnings, Adverse reactions | GABAPENTIN GABAPENTIN |
| Gabapentin | GABAPENTIN | BioComp Pharma, Inc. | 0b3a4009-42f3-c84f-e063-6294a90a8068 | 2025-12-17 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| GABAPENTIN | GABAPENTIN | Camber Pharmaceuticals, Inc. | b86c81d9-9a4a-4847-be18-520e5cc5dc4b | 2025-12-12 | Warnings, Adverse reactions | GABAPENTIN GABAPENTIN |
| Gabapentin | GABAPENTIN | JVET PHARMACEUTICALS LLC | 63a5fc6d-ca57-4726-b70d-805ac023d959 | 2025-12-10 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| Gabapentin | GABAPENTIN | Glenmark Pharmaceuticals Inc., USA | 3865a6e3-112c-490c-82ac-35401336b16e | 2025-12-05 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| Gabapentin | GABAPENTIN | Precision Dose, Inc. | 021329d0-7d32-4fd8-81bf-a8b0d8b49e43 | 2025-12-04 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| GABAPENTIN | GABAPENTIN | Redpharm Drug | 44f2b497-55b2-864f-e063-6294a90ad6d5 | 2025-12-02 | Warnings, Adverse reactions | GABAPENTIN GABAPENTIN |
| Gabapentin | GABAPENTIN | Kesin Pharma Corporation | 4470a567-93a6-a293-e063-6394a90affc1 | 2025-11-25 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| Gabapentin | GABAPENTIN | A-S Medication Solutions | b74a427c-9cc1-4b15-9ed2-cc891741fe67 | 2025-11-19 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| Gabapentin | GABAPENTIN | Strides Pharma Science Limited | bec31452-b52b-4698-ba4c-0b614780ee84 | 2025-11-12 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| Gabapentin | GABAPENTIN | Acella Pharmaceuticals, LLC | 3255245c-6ae6-46ab-a1c1-0b8d4d4cdaa2 | 2025-11-03 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| Gabapentin | GABAPENTIN | Bryant Ranch Prepack | 5134369d-c7f6-4569-a425-d50e5a5d694f | 2025-10-29 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| Gabapentin | GABAPENTIN | Mullan Pharmaceutical Inc. | 47a22de2-ec66-45be-8648-89ed3ab6e67e | 2025-10-28 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| Gabapentin | GABAPENTIN | A-S Medication Solutions | 25befbfa-5125-4363-8306-f862e81c0a6f | 2025-10-28 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| Gabapentin | GABAPENTIN | Bryant Ranch Prepack | d9d78138-e1e9-4107-9099-4910cb1422d8 | 2025-10-22 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| Gabapentin | GABAPENTIN | A-S Medication Solutions | 6e900fc4-a2b3-411f-9ab7-8dcbb97b697b | 2025-10-16 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.