Application 209855
- Type
- ANDA
- Sponsor
- IPCA LABS LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | GABAPENTIN | GABAPENTIN | TABLET;ORAL | 600MG | No | No |
| 002 | GABAPENTIN | GABAPENTIN | TABLET;ORAL | 800MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A209855-001 | GABAPENTIN | GABAPENTIN | 600MG | TABLET / ORAL | 2024-05-29 | ||
| A209855-002 | GABAPENTIN | GABAPENTIN | 800MG | TABLET / ORAL | 2024-05-29 |
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 | A209855-001 | GABAPENTIN | 600MG | TABLET / ORAL | 2024-05-29 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A209855-002 | GABAPENTIN | 800MG | TABLET / ORAL | 2024-05-29 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A209855-001 | GABAPENTIN | 600MG | TABLET / ORAL | 2024-05-29 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A209855-002 | GABAPENTIN | 800MG | TABLET / ORAL | 2024-05-29 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A209855-001 | GABAPENTIN | 600MG | TABLET / ORAL | 2024-05-29 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A209855-002 | GABAPENTIN | 800MG | TABLET / ORAL | 2024-05-29 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209855-001 | GABAPENTIN | 600MG | TABLET / ORAL | 2024-05-29 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209855-002 | GABAPENTIN | 800MG | TABLET / ORAL | 2024-05-29 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A209855-001 | GABAPENTIN | 600MG | TABLET / ORAL | 2024-05-29 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A209855-002 | GABAPENTIN | 800MG | TABLET / ORAL | 2024-05-29 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209855-001 | GABAPENTIN | 600MG | TABLET / ORAL | 2024-05-29 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209855-002 | GABAPENTIN | 800MG | TABLET / ORAL | 2024-05-29 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209855-001 | GABAPENTIN | 600MG | TABLET / ORAL | 2024-05-29 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209855-002 | GABAPENTIN | 800MG | TABLET / ORAL | 2024-05-29 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209855-001 | GABAPENTIN | 600MG | TABLET / ORAL | 2024-05-29 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209855-002 | GABAPENTIN | 800MG | TABLET / ORAL | 2024-05-29 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209855-001 | GABAPENTIN | 600MG | TABLET / ORAL | AB1 | 2024-05-29 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209855-002 | GABAPENTIN | 800MG | TABLET / ORAL | AB1 | 2024-05-29 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209855-001 | GABAPENTIN | 600MG | TABLET / ORAL | AB1 | 2024-05-29 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209855-002 | GABAPENTIN | 800MG | TABLET / ORAL | AB1 | 2024-05-29 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209855-001 | GABAPENTIN | 600MG | TABLET / ORAL | AB1 | 2024-05-29 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209855-002 | GABAPENTIN | 800MG | TABLET / ORAL | AB1 | 2024-05-29 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A209855-001 | GABAPENTIN | 600MG | TABLET / ORAL | AB1 | 2024-05-29 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A209855-002 | GABAPENTIN | 800MG | TABLET / ORAL | AB1 | 2024-05-29 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A209855-001 | GABAPENTIN | 600MG | TABLET / ORAL | AB1 | 2024-05-29 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A209855-002 | GABAPENTIN | 800MG | TABLET / ORAL | AB1 | 2024-05-29 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A209855-001 | GABAPENTIN | 600MG | TABLET / ORAL | AB1 | 2024-05-29 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A209855-002 | GABAPENTIN | 800MG | TABLET / ORAL | AB1 | 2024-05-29 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A209855-001 | GABAPENTIN | 600MG | TABLET / ORAL | AB1 | 2024-05-29 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A209855-002 | GABAPENTIN | 800MG | TABLET / ORAL | AB1 | 2024-05-29 | 1e350fbaab3a… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A209855-001 | GABAPENTIN | 600MG | TABLET / ORAL | 2024-05-29 | a50c72e98297… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A209855-002 | GABAPENTIN | 800MG | TABLET / ORAL | 2024-05-29 | a50c72e98297… |
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 | A209855-001 | AB1 | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209855-002 | AB1 | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209855-001 | AB1 | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209855-002 | AB1 | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209855-001 | AB1 | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209855-002 | AB1 | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A209855-001 | AB1 | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A209855-002 | AB1 | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A209855-001 | AB1 | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A209855-002 | AB1 | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A209855-001 | AB1 | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A209855-002 | AB1 | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A209855-001 | AB1 | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A209855-002 | AB1 | 1 | 1e350fbaab3a… |
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 | Preferred Pharmaceuticals Inc. | 180b99a5-7d3d-4ee5-a0cc-1ae0ede646ee | 2026-05-04 | Warnings, Adverse reactions | GABAPENTIN GABAPENTIN |
| GABAPENTIN | GABAPENTIN | Preferred Pharmaceuticals Inc. | 35da078b-0da0-4757-a6c4-a9144c37e8e1 | 2026-05-01 | Warnings, Adverse reactions | GABAPENTIN GABAPENTIN |
| GABAPENTIN | GABAPENTIN | Preferred Pharmaceuticals Inc. | 38119f2e-33b3-4c3c-99b7-9335d8d280d4 | 2026-05-01 | Warnings, Adverse reactions | GABAPENTIN GABAPENTIN |
| Gabapentin | GABAPENTIN | St. Mary's Medical Park Pharmacy | b8b7e045-a7fe-8539-e053-2a95a90a40f8 | 2026-05-01 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| Gabapentin | GABAPENTIN | St Mary's Medical Park Pharmacy | de990f96-96bc-406d-e053-2995a90abebb | 2026-05-01 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| Gabapentin | GABAPENTIN | Bryant Ranch Prepack | 4cb26d6e-7963-4fe5-903e-ab5180545066 | 2026-05-01 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| Gabapentin | GABAPENTIN | Preferred Pharmaceuticals Inc. | 100ff86c-56a8-4770-9db3-b9bc6b1bd2f7 | 2026-04-30 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| Gabapentin | GABAPENTIN | PD-Rx Pharmaceuticals, Inc. | d22ed424-f365-44ca-8ef9-a08255a90ae8 | 2026-04-29 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| Gabapentin | GABAPENTIN | Preferred Pharmaceuticals Inc. | e3429322-c442-4146-bb68-bcc3a8d01552 | 2026-04-29 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| Gabapentin | GABAPENTIN | Preferred Pharmaceuticals Inc. | 2625c0ef-5295-41de-9e81-88001a6cbecc | 2026-04-29 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| Gabapentin | GABAPENTIN | Preferred Pharmaceuticals Inc. | 6ecf5114-2ddc-4025-a36d-1884702dc22a | 2026-04-29 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| Gabapentin | GABAPENTIN | Preferred Pharmaceuticals Inc. | f396ec70-826d-45c6-a27c-343c2fac878c | 2026-04-29 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| Gabapentin | GABAPENTIN | Preferred Pharmaceuticals, Inc. | 41dcc917-68d1-49f0-8223-44c21ca259ef | 2026-04-29 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| Gabapentin | GABAPENTIN | Coupler LLC | 5073abda-321f-29d1-e063-6394a90a59ac | 2026-04-27 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| Gabapentin | GABAPENTIN | BluePoint Laboratories | 3368bf70-d466-4765-b2b7-7fe967a8c2b7 | 2026-04-24 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| GABAPENTIN | GABAPENTIN | Coupler LLC | 500ee820-0378-6fc9-e063-6394a90a109c | 2026-04-24 | Warnings, Adverse reactions | GABAPENTIN GABAPENTIN |
| GABAPENTIN | GABAPENTIN | Preferred Pharmaceuticals Inc. | dd0e12c2-1986-4ca3-a809-d703a7542419 | 2026-04-22 | Warnings, Adverse reactions | GABAPENTIN GABAPENTIN |
| Gabapentin | GABAPENTIN | PHOENIX RX LLC | 4f95c01f-200e-bfd7-e063-6394a90abc38 | 2026-04-16 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| Gabapentin | GABAPENTIN | Bryant Ranch Prepack | ce0f0d7f-da6d-47da-a4ed-fb8f72902412 | 2026-04-13 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| Gabapentin | GABAPENTIN | Bryant Ranch Prepack | abb56036-88df-4720-ba78-529971671545 | 2026-04-13 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.