Application 076605
- Type
- ANDA
- Sponsor
- RANBAXY
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 |
|---|---|---|---|---|---|---|---|
| A076605-001 | GABAPENTIN | GABAPENTIN | 600MG | TABLET / ORAL | 2005-09-14 | ||
| A076605-002 | GABAPENTIN | GABAPENTIN | 800MG | TABLET / ORAL | 2005-09-14 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A076605-001 | GABAPENTIN | 600MG | TABLET / ORAL | 2005-09-14 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076605-002 | GABAPENTIN | 800MG | TABLET / ORAL | 2005-09-14 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076605-001 | GABAPENTIN | 600MG | TABLET / ORAL | 2005-09-14 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076605-002 | GABAPENTIN | 800MG | TABLET / ORAL | 2005-09-14 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076605-001 | GABAPENTIN | 600MG | TABLET / ORAL | 2005-09-14 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076605-002 | GABAPENTIN | 800MG | TABLET / ORAL | 2005-09-14 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076605-001 | GABAPENTIN | 600MG | TABLET / ORAL | 2005-09-14 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076605-002 | GABAPENTIN | 800MG | TABLET / ORAL | 2005-09-14 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076605-001 | GABAPENTIN | 600MG | TABLET / ORAL | 2005-09-14 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076605-002 | GABAPENTIN | 800MG | TABLET / ORAL | 2005-09-14 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076605-001 | GABAPENTIN | 600MG | TABLET / ORAL | 2005-09-14 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076605-002 | GABAPENTIN | 800MG | TABLET / ORAL | 2005-09-14 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076605-001 | GABAPENTIN | 600MG | TABLET / ORAL | 2005-09-14 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076605-002 | GABAPENTIN | 800MG | TABLET / ORAL | 2005-09-14 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076605-001 | GABAPENTIN | 600MG | TABLET / ORAL | 2005-09-14 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076605-002 | GABAPENTIN | 800MG | TABLET / ORAL | 2005-09-14 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076605-001 | GABAPENTIN | 600MG | TABLET / ORAL | 2005-09-14 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076605-002 | GABAPENTIN | 800MG | TABLET / ORAL | 2005-09-14 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A076605-001 | GABAPENTIN | 600MG | TABLET / ORAL | 2005-09-14 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A076605-002 | GABAPENTIN | 800MG | TABLET / ORAL | 2005-09-14 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076605-001 | GABAPENTIN | 600MG | TABLET / ORAL | 2005-09-14 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076605-002 | GABAPENTIN | 800MG | TABLET / ORAL | 2005-09-14 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076605-001 | GABAPENTIN | 600MG | TABLET / ORAL | 2005-09-14 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076605-002 | GABAPENTIN | 800MG | TABLET / ORAL | 2005-09-14 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076605-001 | GABAPENTIN | 600MG | TABLET / ORAL | 2005-09-14 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076605-002 | GABAPENTIN | 800MG | TABLET / ORAL | 2005-09-14 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A076605-001 | GABAPENTIN | 600MG | TABLET / ORAL | 2005-09-14 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A076605-002 | GABAPENTIN | 800MG | TABLET / ORAL | 2005-09-14 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A076605-001 | GABAPENTIN | 600MG | TABLET / ORAL | 2005-09-14 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A076605-002 | GABAPENTIN | 800MG | TABLET / ORAL | 2005-09-14 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A076605-001 | GABAPENTIN | 600MG | TABLET / ORAL | 2005-09-14 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A076605-002 | GABAPENTIN | 800MG | TABLET / ORAL | 2005-09-14 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A076605-001 | GABAPENTIN | 600MG | TABLET / ORAL | 2005-09-14 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A076605-002 | GABAPENTIN | 800MG | TABLET / ORAL | 2005-09-14 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A076605-001 | GABAPENTIN | 600MG | TABLET / ORAL | 2005-09-14 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A076605-002 | GABAPENTIN | 800MG | TABLET / ORAL | 2005-09-14 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A076605-001 | GABAPENTIN | 600MG | TABLET / ORAL | 2005-09-14 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A076605-002 | GABAPENTIN | 800MG | TABLET / ORAL | 2005-09-14 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A076605-001 | GABAPENTIN | 600MG | TABLET / ORAL | 2005-09-14 | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A076605-002 | GABAPENTIN | 800MG | TABLET / ORAL | 2005-09-14 | 782e0a99824c… |
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 | REMEDYREPACK INC. | 81243958-cc5a-4ec0-a64d-71682f949d5f | 2026-07-30 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| Gabapentin | GABAPENTIN | REMEDYREPACK INC. | bc525ae4-9843-4038-a1b7-0d3543e2282c | 2026-07-30 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| Gabapentin | GABAPENTIN | TAGI Pharma, Inc. | 725878fa-1e2f-4fee-a9e1-a6e102c79625 | 2026-07-28 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| Gabapentin | GABAPENTIN | Ascend Laboratories, LLC | 722de2a9-38b3-4518-b262-ba0d1346d0ba | 2026-07-24 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| Gabapentin | GABAPENTIN | REMEDYREPACK INC. | 5a78ab50-993d-4857-be10-be665e02b353 | 2026-07-23 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| Gabapentin | GABAPENTIN | REMEDYREPACK INC. | 429a1bb5-babf-4f36-8264-46d71164f1c0 | 2026-07-22 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| Gabapentin | GABAPENTIN | NuCare Pharmaceuticals, Inc. | 57383d2a-d2c7-bbdc-e063-6294a90ada98 | 2026-07-22 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| 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 | REMEDYREPACK INC. | 07c8bb17-9bd4-4fab-994d-0412205b53b4 | 2026-07-17 | 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. | 896c7782-1137-454b-aaa6-28f42c7413ef | 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 |