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 | ScieGen Pharmaceuticals, Inc. | 16542ee6-0e0e-4d3c-8b32-60ff6ef48846 | 2026-07-21 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| gabapentin | GABAPENTIN | REMEDYREPACK INC. | 32169228-e85c-4dbf-8722-cd2f8e0f5d1a | 2026-07-20 | Warnings, Adverse reactions | gabapentin GABAPENTIN |
| Gabapentin | GABAPENTIN | St. Mary's Medical Park Pharmacy | 57492b91-1fe2-74ab-e063-6394a90a0b9e | 2026-07-20 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| Gabapentin | GABAPENTIN | PD-Rx Pharmaceuticals, Inc. | 4a95f18e-0de4-4ce1-9f97-bc2e8a5bac6a | 2026-07-17 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| Gabapentin | GABAPENTIN | St. Mary's Medical Park Pharmacy | 3c585b71-5cfc-18d6-e063-6294a90a3dcf | 2026-07-17 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| Gabapentin | GABAPENTIN | Bryant Ranch Prepack | 172776c0-909e-49ce-bfe1-cf154a9458ba | 2026-07-15 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| Gabapentin | GABAPENTIN | Bryant Ranch Prepack | a1006139-7dfc-4d87-a5a9-aeb380c32d24 | 2026-07-15 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| Gabapentin | GABAPENTIN | Bryant Ranch Prepack | df9c7c84-a8d9-4da8-babe-c55c9420d4e6 | 2026-07-15 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| Gabapentin | GABAPENTIN | REMEDYREPACK INC. | 6beed8eb-446c-4575-8dc8-b798623d92c7 | 2026-07-15 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| Gabapentin | GABAPENTIN | REMEDYREPACK INC. | 7ddc7d92-9076-41cf-97ed-d9f9edc80298 | 2026-07-15 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| Gabapentin | GABAPENTIN | Bryant Ranch Prepack | 72729513-bd34-44f5-9f62-297ed25c4442 | 2026-07-15 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| Gabapentin | GABAPENTIN | Bryant Ranch Prepack | f31172a2-0ae9-49f2-b797-b26fe33f3f64 | 2026-07-15 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| Gabapentin | GABAPENTIN | Bryant Ranch Prepack | 6a0a75ac-e121-477b-a9d1-d11f588afc9d | 2026-07-14 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| Gabapentin | GABAPENTIN | Bryant Ranch Prepack | b6db5ce9-bd4b-420d-88a7-df9d46144c81 | 2026-07-10 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| Gabapentin | GABAPENTIN | PD-Rx Pharmaceuticals, Inc. | 9b175f8d-7667-4bfe-8bb5-fd7441eed456 | 2026-07-08 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| Gabapentin | GABAPENTIN | St. Mary's Medical Park Pharmacy | 4ddcdff5-8f1f-bff3-e063-6294a90a1195 | 2026-07-07 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| Gabapentin | GABAPENTIN | HAWAII REPACK, INC. | dd7adad2-e2f5-4b43-90a4-522bce0be5b3 | 2026-07-02 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| Gabapentin | GABAPENTIN | HAWAII REPACK, INC. | f6ff265b-569b-4f5c-8fdb-00b7ad4aac7c | 2026-07-02 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| gabapentin | GABAPENTIN | Sun Pharmaceutical Industries, Inc. | c9a05f0c-b5f0-422c-9d67-6d0efc921a74 | 2026-07-02 | Warnings, Adverse reactions | gabapentin GABAPENTIN |
| GABAPENTIN | GABAPENTIN | Strides Pharma Science Limited | 43b67ae3-ac6f-48f5-8788-9ead08376864 | 2026-07-02 | Warnings, Adverse reactions | GABAPENTIN GABAPENTIN |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.