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 | DIRECT RX | a7e45e3f-e382-32ba-e053-2a95a90a2537 | 2025-01-17 | GABAPENTIN GABAPENTIN | |
| Gabapentin | GABAPENTIN | Clinical Solutions Wholesale, LLC | 743faa18-5e7c-4fcc-9781-4157450d90c4 | 2025-01-16 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| Gabapentin | GABAPENTIN | NuCare Pharmaceuticals,Inc. | bd5c9279-a1e3-2a59-e053-2a95a90a33a2 | 2025-01-14 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| Gabapentin | GABAPENTIN | Aphena Pharma Solutions - Tennessee, LLC | 41ce952c-6c16-4b5d-adf7-9ea114e63eb3 | 2025-01-09 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| Gabapentin | GABAPENTIN | Aphena Pharma Solutions - Tennessee, LLC | 13b87441-8fe1-40f5-8ffb-00dcd8cc90a6 | 2025-01-09 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| Gabapentin | GABAPENTIN | AvPAK | faa47fcd-2545-a946-e053-6294a90a05d2 | 2025-01-09 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| Gabapentin | GABAPENTIN | Aphena Pharma Solutions - Tennessee, LLC | 95757436-2093-41cf-a9a9-ef2f28ac096f | 2025-01-09 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| GABAPENTIN | GABAPENTIN | NuCare Pharmaceuticals,Inc. | 2b395a14-0f8e-7f5b-e063-6294a90ab546 | 2025-01-08 | Warnings, Adverse reactions | GABAPENTIN GABAPENTIN |
| Gabapentin | GABAPENTIN | Advanced Rx of Tennessee, LLC | afa28969-91ca-83fd-e053-2a95a90a656b | 2024-12-31 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| Gabapentin | GABAPENTIN | Advanced Rx of Tennessee, LLC | afa28969-91c8-83fd-e053-2a95a90a656b | 2024-12-31 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| Gabapentin | GABAPENTIN | ADVANCED RX OF TENNESSEE, LLC | af73fbd8-9731-e6bf-e053-2995a90af65d | 2024-12-31 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| Gabapentin | GABAPENTIN | Advanced Rx of Tennessee, LLC | afc80b8b-da39-6fb9-e053-2a95a90a2d8e | 2024-12-31 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| Gabapentin | GABAPENTIN | Advanced Rx of Tennessee, LLC | b062f12c-a745-76d4-e053-2a95a90a3a1a | 2024-12-31 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| Gabapentin | GABAPENTIN | Advanced Rx of Tennessee, LLC | b33c18ea-554d-3cfb-e053-2a95a90a2dd1 | 2024-12-31 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| Gabapentin | GABAPENTIN | Advanced Rx of Tennessee, LLC | b37b1dcc-c7e9-8845-e053-2995a90a089e | 2024-12-31 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| Gabapentin | GABAPENTIN | Advanced Rx Pharmacy of Tennessee, LLC | c898711b-9a65-1816-e053-2995a90a855e | 2024-12-31 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| Gabapentin | GABAPENTIN | Advanced Rx of Tennessee, LLC | d294f6aa-ed82-90a2-e053-2995a90a2896 | 2024-12-31 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| Gabapentin | GABAPENTIN | Advanced Rx Pharmacy of Tennessee, LLC | ec1c621b-db2a-1567-e053-2995a90a8695 | 2024-12-31 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| Gabapentin | GABAPENTIN | Advanced Rx Pharmacy of Tennessee, LLC | c89a68b6-6dc0-4624-e053-2a95a90a687e | 2024-12-31 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| Gabapentin | GABAPENTIN | Advanced Rx Pharmacy of Tennessee, LLC | bc08e35d-ef5d-1dcd-e053-2a95a90ab5de | 2024-12-31 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.