Application 078782
- Type
- ANDA
- Sponsor
- HIKMA PHARMS
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 |
|---|---|---|---|---|---|---|---|
| A078782-001 | GABAPENTIN | GABAPENTIN | 600MG | TABLET / ORAL | 2011-07-21 | ||
| A078782-002 | GABAPENTIN | GABAPENTIN | 800MG | TABLET / ORAL | 2011-07-21 |
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 | A078782-001 | GABAPENTIN | 600MG | TABLET / ORAL | 2011-07-21 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A078782-002 | GABAPENTIN | 800MG | TABLET / ORAL | 2011-07-21 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A078782-001 | GABAPENTIN | 600MG | TABLET / ORAL | 2011-07-21 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A078782-002 | GABAPENTIN | 800MG | TABLET / ORAL | 2011-07-21 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A078782-001 | GABAPENTIN | 600MG | TABLET / ORAL | 2011-07-21 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A078782-002 | GABAPENTIN | 800MG | TABLET / ORAL | 2011-07-21 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078782-001 | GABAPENTIN | 600MG | TABLET / ORAL | 2011-07-21 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078782-002 | GABAPENTIN | 800MG | TABLET / ORAL | 2011-07-21 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A078782-001 | GABAPENTIN | 600MG | TABLET / ORAL | 2011-07-21 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A078782-002 | GABAPENTIN | 800MG | TABLET / ORAL | 2011-07-21 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078782-001 | GABAPENTIN | 600MG | TABLET / ORAL | 2011-07-21 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078782-002 | GABAPENTIN | 800MG | TABLET / ORAL | 2011-07-21 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078782-001 | GABAPENTIN | 600MG | TABLET / ORAL | 2011-07-21 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078782-002 | GABAPENTIN | 800MG | TABLET / ORAL | 2011-07-21 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078782-001 | GABAPENTIN | 600MG | TABLET / ORAL | 2011-07-21 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078782-002 | GABAPENTIN | 800MG | TABLET / ORAL | 2011-07-21 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078782-001 | GABAPENTIN | 600MG | TABLET / ORAL | 2011-07-21 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078782-002 | GABAPENTIN | 800MG | TABLET / ORAL | 2011-07-21 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078782-001 | GABAPENTIN | 600MG | TABLET / ORAL | 2011-07-21 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078782-002 | GABAPENTIN | 800MG | TABLET / ORAL | 2011-07-21 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078782-001 | GABAPENTIN | 600MG | TABLET / ORAL | 2011-07-21 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078782-002 | GABAPENTIN | 800MG | TABLET / ORAL | 2011-07-21 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A078782-001 | GABAPENTIN | 600MG | TABLET / ORAL | 2011-07-21 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A078782-002 | GABAPENTIN | 800MG | TABLET / ORAL | 2011-07-21 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078782-001 | GABAPENTIN | 600MG | TABLET / ORAL | 2011-07-21 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078782-002 | GABAPENTIN | 800MG | TABLET / ORAL | 2011-07-21 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078782-001 | GABAPENTIN | 600MG | TABLET / ORAL | 2011-07-21 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078782-002 | GABAPENTIN | 800MG | TABLET / ORAL | 2011-07-21 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078782-001 | GABAPENTIN | 600MG | TABLET / ORAL | 2011-07-21 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078782-002 | GABAPENTIN | 800MG | TABLET / ORAL | 2011-07-21 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A078782-001 | GABAPENTIN | 600MG | TABLET / ORAL | 2011-07-21 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A078782-002 | GABAPENTIN | 800MG | TABLET / ORAL | 2011-07-21 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A078782-001 | GABAPENTIN | 600MG | TABLET / ORAL | 2011-07-21 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A078782-002 | GABAPENTIN | 800MG | TABLET / ORAL | 2011-07-21 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A078782-001 | GABAPENTIN | 600MG | TABLET / ORAL | 2011-07-21 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A078782-002 | GABAPENTIN | 800MG | TABLET / ORAL | 2011-07-21 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A078782-001 | GABAPENTIN | 600MG | TABLET / ORAL | 2011-07-21 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A078782-002 | GABAPENTIN | 800MG | TABLET / ORAL | 2011-07-21 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A078782-001 | GABAPENTIN | 600MG | TABLET / ORAL | 2011-07-21 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A078782-002 | GABAPENTIN | 800MG | TABLET / ORAL | 2011-07-21 | 74a2ff9319b5… |
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. | 7f830664-2fa3-4d73-a154-775fbb8fd65d | 2026-09-10 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| Gabapentin | GABAPENTIN | REMEDYREPACK INC. | 167d8b87-506c-4293-9579-563feaa71583 | 2026-09-10 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| Gabapentin | GABAPENTIN | Clinical Solutions Wholesale, LLC | b7f9a106-52c6-49e4-acf5-8fb07761ba4f | 2026-09-09 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| Gabapentin | GABAPENTIN | NuCare Pharmaceuticals,Inc. | d35cd5ac-5ed6-2405-e053-2995a90a6946 | 2026-09-03 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| GABAPENTIN | GABAPENTIN | PHOENIX RX LLC | 5a85ea98-4211-54eb-e063-6294a90aff33 | 2026-09-02 | Warnings, Adverse reactions | GABAPENTIN GABAPENTIN |
| Gabapentin | GABAPENTIN | REMEDYREPACK INC. | 3dac0d5f-6e65-4c58-9d2a-4f6910b2d4ef | 2026-09-01 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| GABAPENTIN | GABAPENTIN | REMEDYREPACK INC. | 1373587e-807a-462a-bff6-8a7113ce9f0a | 2026-09-01 | Warnings, Adverse reactions | GABAPENTIN GABAPENTIN |
| Gabapentin | GABAPENTIN | REMEDYREPACK INC. | 78445dbf-c7cd-419f-a7be-72821e496628 | 2026-08-28 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| Gabapentin | GABAPENTIN | REMEDYREPACK INC. | 4615aaa7-73d4-4473-8f26-e7a982f8a166 | 2026-08-27 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| Gabapentin | GABAPENTIN | Bryant Ranch Prepack | 1af098ad-28b5-463f-8efa-24d70a77d64c | 2026-08-26 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| Gabapentin | GABAPENTIN | Bryant Ranch Prepack | 9a2658d5-9b0e-4921-b4c5-4c89f1630d69 | 2026-08-26 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| Gabapentin | GABAPENTIN | Bryant Ranch Prepack | 43cbff48-8219-41ba-b67d-3ae4544b78bb | 2026-08-26 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| GABAPENTIN | GABAPENTIN | Bryant Ranch Prepack | 4c22c3e6-2471-4b89-945b-f846c4d7884e | 2026-08-25 | Warnings, Adverse reactions | GABAPENTIN GABAPENTIN |
| Gabapentin | GABAPENTIN | Cardinal Health 107, LLC | 934244c6-243d-436e-ad6c-f7bd28e45a86 | 2026-08-24 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| Gabapentin | GABAPENTIN | REMEDYREPACK INC. | d06380d0-c894-427e-b13e-5a8f9eb86a34 | 2026-08-21 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| Gabapentin | GABAPENTIN | REMEDYREPACK INC. | 7652adc6-1aad-4422-b85c-0c6b11c23b73 | 2026-08-21 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| Gabapentin | GABAPENTIN | Bryant Ranch Prepack | f0e7a6c9-ae6c-4259-81ab-a37db54e3c80 | 2026-08-19 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| gabapentin | GABAPENTIN | NuCare Pharmaceuticals, Inc. | 596eb696-7696-202e-e063-6394a90a2844 | 2026-08-19 | Warnings, Adverse reactions | gabapentin GABAPENTIN |
| Gabapentin | GABAPENTIN | Bryant Ranch Prepack | eb2f6784-e7be-41b6-871b-2c3c961664ab | 2026-08-19 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |
| Gabapentin | GABAPENTIN | Bryant Ranch Prepack | 8a781649-3271-47a6-995f-50f91141a48a | 2026-08-19 | Warnings, Adverse reactions | Gabapentin GABAPENTIN |