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 | Bryant Ranch Prepack | 657349fb-41a9-4814-b4ac-4c5afbdde947 | 2024-10-30 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| Gabapentin | GABAPENTIN | Bryant Ranch Prepack | a15d5dcc-63c4-4c06-ab91-5e22cdf234cc | 2024-10-30 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| Gabapentin | GABAPENTIN | Bryant Ranch Prepack | 477691f5-0591-4544-840a-ac590e1f25a1 | 2024-10-30 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| Gabapentin | GABAPENTIN | Bryant Ranch Prepack | 506bf880-9564-404c-951a-703797ffdad8 | 2024-10-29 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| Gabapentin | GABAPENTIN | Bryant Ranch Prepack | 77754734-4125-42b1-97c8-458bcab2bcf1 | 2024-10-23 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| Gabapentin | GABAPENTIN | Bryant Ranch Prepack | fb0b6613-57d6-4e24-946f-f5f87c460cf0 | 2024-10-18 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| Gabapentin | GABAPENTIN | Bryant Ranch Prepack | ef37f2a0-3b83-4f71-91c0-6435161b483c | 2024-10-18 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| Gabapentin | GABAPENTIN | Bryant Ranch Prepack | ff28c5f1-da56-4072-a6fa-d689d4a6761b | 2024-10-07 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| Gabapentin | GABAPENTIN | Direct_Rx | fbc05ceb-2e69-3c37-e053-6394a90ac4f4 | 2024-09-06 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| Gabapentin | GABAPENTIN | Bryant Ranch Prepack | 2dad630a-09d8-4f40-bdad-24e877a9ee38 | 2024-09-03 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| Gabapentin | GABAPENTIN | Creekwood Pharmaceuticals LLC | 26aac429-a5cd-33cc-e063-6394a90aecc0 | 2024-09-01 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| Gabapentin | GABAPENTIN | Creekwood Pharmaceuticals LLC | 266ef369-0a56-f225-e063-6294a90a495e | 2024-09-01 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| Gabapentin | GABAPENTIN | Boswell Pharmacy Services LLC d/b/a BPS Wholesale | 1e28ad3d-2d34-a5d0-e063-6294a90adb9e | 2024-07-26 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| Gabapentin | GABAPENTIN | NuCare Pharmaceuticals,Inc. | a9c99dfa-f54d-9207-e053-2995a90ad43b | 2024-07-17 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| Gabapentin | GABAPENTIN | NuCare Pharmaceuticals,Inc. | a9f0852e-0c58-ba22-e053-2995a90adfa0 | 2024-07-17 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| Gabapentin | GABAPENTIN | Bryant Ranch Prepack | 6e6b9d8f-9f9e-4760-96ea-fb8b0a3bbbdb | 2024-07-08 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| GABAPENTIN | GABAPENTIN | NuCare Pharmaceuticals,Inc. | 8f785189-bf66-36cc-e053-2a95a90a7cbc | 2024-06-19 | GABAPENTIN GABAPENTIN | |
| Gabapentin | GABAPENTIN | NuCare Pharmaceuticals,Inc. | 8e6ed5d2-40e0-1f06-e053-2a95a90aa40e | 2024-06-18 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| GABAPENTIN | GABAPENTIN | NuCare Pharmaceuticals,Inc. | 82c0ed15-9132-657d-e053-2991aa0ae90a | 2024-06-14 | GABAPENTIN GABAPENTIN | |
| Gabapentin | GABAPENTIN | Bryant Ranch Prepack | ffe5321d-3405-46d5-a75f-c51e8f8d87b1 | 2024-05-29 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.