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 |
|---|---|---|---|---|---|---|
| GABAPENTIN | GABAPENTIN | Proficient Rx LP | 7fcce531-bf7c-43b6-bea9-8f0602842c53 | 2025-04-01 | Warnings, Adverse reactions | GABAPENTIN GABAPENTIN |
| GABAPENTIN | GABAPENTIN | Coupler LLC | 3133c863-d33b-c9d7-e063-6294a90ae898 | 2025-03-25 | Warnings, Adverse reactions | GABAPENTIN GABAPENTIN |
| Gabapentin | GABAPENTIN | Coupler LLC | 3133fc78-dd7a-880c-e063-6394a90a89e1 | 2025-03-25 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| Gabapentin | GABAPENTIN | Precision Dose, Inc. | 86c93d8b-6286-44e2-93dd-f1b10a5d83da | 2025-03-10 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| Gabapentin | GABAPENTIN | Proficient Rx LP | 87b9171b-7d00-40fa-87ff-a717740efe8a | 2025-03-02 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| Gabapentin | GABAPENTIN | Proficient Rx LP | 64a65366-8577-48f2-9f8e-0332f126d3c1 | 2025-03-01 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| GABAPENTIN | GABAPENTIN | NuCare Pharmaceuticals, Inc. | 200b61d7-6e4c-923d-e063-6294a90a42cf | 2025-02-21 | Warnings, Adverse reactions | GABAPENTIN GABAPENTIN |
| GABAPENTIN | GABAPENTIN | Bryant Ranch Prepack | 35ac6b11-7b1c-47a0-a4ba-c193a0bb5b01 | 2025-02-20 | Warnings, Adverse reactions | GABAPENTIN GABAPENTIN |
| GABAPENTIN | GABAPENTIN | NuCare Pharmaceuticals,Inc. | febf610e-e088-4797-e053-6294a90a3eb5 | 2025-02-04 | Warnings, Adverse reactions | GABAPENTIN GABAPENTIN |
| Gabapentin | GABAPENTIN | NuCare Pharmaceuticals,Inc. | 07871ab8-254b-e3c2-e063-6294a90a29ab | 2025-02-03 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| Gabapentin | GABAPENTIN | NuCare Pharmaceuticals,Inc. | 0919fed8-e968-b5ac-e063-6294a90afbff | 2025-02-03 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| Gabapentin | GABAPENTIN | Bryant Ranch Prepack | a1ff94a9-69c4-486a-aab2-563c7ed244c8 | 2025-01-30 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| GABAPENTIN | GABAPENTIN | Coupler LLC | 2cdbb381-88a2-5c5a-e063-6294a90a3e1e | 2025-01-29 | Warnings, Adverse reactions | GABAPENTIN GABAPENTIN |
| Gabapentin | GABAPENTIN | NuCare Pharmaceuticals, Inc. | 2c65253d-ca49-70eb-e063-6394a90a3cd2 | 2025-01-23 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| Gabapentin | GABAPENTIN | Direct_Rx | e90d2e3d-ec86-7d1d-e053-2995a90a9167 | 2025-01-22 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| Gabapentin | GABAPENTIN | Direct_Rx | ed9cb5fe-7a2e-e0bc-e053-2a95a90a4470 | 2025-01-22 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| Gabapentin | GABAPENTIN | Direct_Rx | f40a4ee4-ae8e-769c-e053-2a95a90a344e | 2025-01-22 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| Gabapentin | GABAPENTIN | Directrx | d5c9dd2c-b8ee-1406-e053-2995a90a0287 | 2025-01-21 | Adverse reactions | Gabapentin GABAPENTIN |
| Gabapentin | GABAPENTIN | Preferred Pharmaceuticals Inc. | db57e37f-0a78-4c14-8768-a28bbf9fa0da | 2025-01-21 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| GABAPENTIN | GABAPENTIN | DIRECT RX | a5b47f89-ed35-31de-e053-2a95a90a5554 | 2025-01-17 | Warnings, Adverse reactions | GABAPENTIN GABAPENTIN |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.