Application 090858
- Type
- ANDA
- Sponsor
- ALKEM
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 |
|---|---|---|---|---|---|---|---|
| A090858-001 | GABAPENTIN | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2010-12-17 | |
| A090858-002 | GABAPENTIN | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2010-12-17 | |
| A090858-003 | GABAPENTIN | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2010-12-17 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A090858-001 | AB |
| A090858-002 | AB |
| A090858-003 | AB |
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 | A090858-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2010-12-17 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A090858-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2010-12-17 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A090858-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2010-12-17 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A090858-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2010-12-17 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A090858-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2010-12-17 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A090858-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2010-12-17 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A090858-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2010-12-17 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A090858-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2010-12-17 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A090858-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2010-12-17 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090858-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2010-12-17 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090858-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2010-12-17 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090858-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2010-12-17 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A090858-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2010-12-17 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A090858-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2010-12-17 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A090858-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2010-12-17 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090858-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2010-12-17 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090858-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2010-12-17 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090858-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2010-12-17 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090858-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2010-12-17 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090858-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2010-12-17 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090858-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2010-12-17 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090858-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2010-12-17 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090858-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2010-12-17 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090858-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2010-12-17 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090858-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2010-12-17 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090858-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2010-12-17 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090858-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2010-12-17 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090858-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2010-12-17 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090858-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2010-12-17 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090858-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2010-12-17 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090858-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2010-12-17 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090858-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2010-12-17 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090858-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2010-12-17 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A090858-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2010-12-17 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A090858-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2010-12-17 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A090858-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2010-12-17 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090858-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2010-12-17 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090858-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2010-12-17 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090858-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2010-12-17 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090858-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2010-12-17 | 301d65b070ca… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A090858-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A090858-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A090858-003 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A090858-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A090858-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A090858-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A090858-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A090858-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A090858-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090858-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090858-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090858-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A090858-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A090858-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A090858-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090858-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090858-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090858-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090858-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090858-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090858-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090858-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090858-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090858-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090858-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090858-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090858-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090858-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090858-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090858-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090858-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090858-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090858-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A090858-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A090858-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A090858-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090858-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090858-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090858-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090858-001 | AB | 1 | 301d65b070ca… |
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. | 78445dbf-c7cd-419f-a7be-72821e496628 | 2026-08-28 | Warnings, Adverse reactions | 090858 ANDA090858 70518-1469 |
| Gabapentin | GABAPENTIN | REMEDYREPACK INC. | d06380d0-c894-427e-b13e-5a8f9eb86a34 | 2026-08-21 | Warnings, Adverse reactions | 090858 ANDA090858 70518-1760 |
| Gabapentin | GABAPENTIN | REMEDYREPACK INC. | 7652adc6-1aad-4422-b85c-0c6b11c23b73 | 2026-08-21 | Warnings, Adverse reactions | 090858 ANDA090858 70518-1834 |
| Gabapentin | GABAPENTIN | Bryant Ranch Prepack | f0e7a6c9-ae6c-4259-81ab-a37db54e3c80 | 2026-08-19 | Warnings, Adverse reactions | 090858 ANDA090858 71335-1496 |
| Gabapentin | GABAPENTIN | Bryant Ranch Prepack | eb2f6784-e7be-41b6-871b-2c3c961664ab | 2026-08-19 | Warnings, Adverse reactions | 090858 ANDA090858 71335-1199 |
| Gabapentin | GABAPENTIN | Bryant Ranch Prepack | 8a781649-3271-47a6-995f-50f91141a48a | 2026-08-19 | Warnings, Adverse reactions | 090858 ANDA090858 71335-1198 |
| Gabapentin | GABAPENTIN | Bryant Ranch Prepack | 6670a64f-7f58-479f-b285-394abb753e2e | 2026-08-19 | Warnings, Adverse reactions | 090858 ANDA090858 71335-1269 |
| Gabapentin | GABAPENTIN | REMEDYREPACK INC. | ddb3a54f-5224-4024-8804-b2a2f01d885e | 2026-08-06 | Warnings, Adverse reactions | 090858 ANDA090858 70518-3329 |
| Gabapentin | GABAPENTIN | REMEDYREPACK INC. | fce0c123-29d7-42bf-8c8d-8be1772e2d99 | 2026-08-06 | Warnings, Adverse reactions | 090858 ANDA090858 70518-3330 |
| Gabapentin | GABAPENTIN | Cardinal Health 107, LLC | 41844c21-9e2a-4332-a8ff-9b71ae9032b0 | 2026-07-30 | Warnings, Adverse reactions | 090858 ANDA090858 |
| Gabapentin | GABAPENTIN | Ascend Laboratories, LLC | 722de2a9-38b3-4518-b262-ba0d1346d0ba | 2026-07-24 | Warnings, Adverse reactions | 090858 ANDA090858 |
| Gabapentin | GABAPENTIN | Bryant Ranch Prepack | a1006139-7dfc-4d87-a5a9-aeb380c32d24 | 2026-07-15 | Warnings, Adverse reactions | 090858 ANDA090858 71335-2053 |
| Gabapentin | GABAPENTIN | Bryant Ranch Prepack | 6a0a75ac-e121-477b-a9d1-d11f588afc9d | 2026-07-14 | Warnings, Adverse reactions | 090858 ANDA090858 71335-1197 |
| Gabapentin | GABAPENTIN | HAWAII REPACK, INC. | 14d61caa-17ce-4fa2-90fb-1470f3864be8 | 2026-06-26 | Warnings, Adverse reactions | 090858 ANDA090858 |
| Gabapentin | GABAPENTIN | Northwind Health Company, LLC | 552912b2-be59-0333-e063-6394a90a85c0 | 2026-06-25 | Warnings, Adverse reactions | 090858 ANDA090858 |
| Gabapentin | GABAPENTIN | Northwind Health Company, LLC | 55292235-bf8f-46d0-e063-6294a90a91a5 | 2026-06-25 | Warnings, Adverse reactions | 090858 ANDA090858 |
| Gabapentin | GABAPENTIN | Unit Dose Solutions, Inc. | 54ecc64b-f019-9fcb-e063-6294a90a00af | 2026-06-23 | Warnings, Adverse reactions | 090858 ANDA090858 |
| Gabapentin | GABAPENTIN | A-S Medication Solutions | 03031adf-d36b-45ec-944e-dfce5a5de91a | 2026-05-28 | Warnings, Adverse reactions | 090858 ANDA090858 |
| Gabapentin | GABAPENTIN | Cardinal Health 107, LLC | d4f21e97-5e55-44c9-9b31-5f79ac2eb512 | 2026-05-18 | Warnings, Adverse reactions | 090858 ANDA090858 |
| Gabapentin | GABAPENTIN | Major Pharmaceuticals | 999f3685-2eac-467e-bed2-1d0c36aaf0ed | 2026-05-04 | Warnings, Adverse reactions | 090858 ANDA090858 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 70518-0053 | Gabapentin | Gabapentin | REMEDYREPACK INC. | ANDA | Current |
| 70518-0293 | Gabapentin | Gabapentin | REMEDYREPACK INC. | ANDA | Current |
| 70518-0293 | Gabapentin | Gabapentin | REMEDYREPACK INC. | ANDA | Current |
| 70518-0293 | Gabapentin | Gabapentin | REMEDYREPACK INC. | ANDA | Current |
| 70518-0293 | Gabapentin | Gabapentin | REMEDYREPACK INC. | ANDA | Current |
| 70518-0293 | Gabapentin | Gabapentin | REMEDYREPACK INC. | ANDA | Current |
| 70518-0293 | Gabapentin | Gabapentin | REMEDYREPACK INC. | ANDA | Current |
| 70518-0293 | Gabapentin | Gabapentin | REMEDYREPACK INC. | ANDA | Current |
| 70518-1469 | Gabapentin | Gabapentin | REMEDYREPACK INC. | ANDA | Current |
| 70518-1469 | Gabapentin | Gabapentin | REMEDYREPACK INC. | ANDA | Current |
| 70518-1469 | Gabapentin | Gabapentin | REMEDYREPACK INC. | ANDA | Current |
| 70518-1469 | Gabapentin | Gabapentin | REMEDYREPACK INC. | ANDA | Current |
| 70518-1469 | Gabapentin | Gabapentin | REMEDYREPACK INC. | ANDA | Current |
| 70518-1469 | Gabapentin | Gabapentin | REMEDYREPACK INC. | ANDA | Current |
| 70518-1469 | Gabapentin | Gabapentin | REMEDYREPACK INC. | ANDA | Current |
| 70518-1760 | Gabapentin | Gabapentin | REMEDYREPACK INC. | ANDA | Current |
| 70518-1760 | Gabapentin | Gabapentin | REMEDYREPACK INC. | ANDA | Current |
| 70518-1760 | Gabapentin | Gabapentin | REMEDYREPACK INC. | ANDA | Current |
| 70518-1760 | Gabapentin | Gabapentin | REMEDYREPACK INC. | ANDA | Current |
| 70518-1760 | Gabapentin | Gabapentin | REMEDYREPACK INC. | ANDA | Current |
| 70518-1760 | Gabapentin | Gabapentin | REMEDYREPACK INC. | ANDA | Current |
| 70518-1760 | Gabapentin | Gabapentin | REMEDYREPACK INC. | ANDA | Current |
| 70518-1760 | Gabapentin | Gabapentin | REMEDYREPACK INC. | ANDA | Current |
| 70518-1760 | Gabapentin | Gabapentin | REMEDYREPACK INC. | ANDA | Current |
| 70518-1760 | Gabapentin | Gabapentin | REMEDYREPACK INC. | ANDA | Current |
| 70518-1834 | Gabapentin | Gabapentin | REMEDYREPACK INC. | ANDA | Current |
| 70518-1834 | Gabapentin | Gabapentin | REMEDYREPACK INC. | ANDA | Current |
| 70518-1834 | Gabapentin | Gabapentin | REMEDYREPACK INC. | ANDA | Current |
| 70518-1834 | Gabapentin | Gabapentin | REMEDYREPACK INC. | ANDA | Current |
| 70518-2614 | Gabapentin | Gabapentin | REMEDYREPACK INC. | ANDA | Current |
| 70518-2614 | Gabapentin | Gabapentin | REMEDYREPACK INC. | ANDA | Current |
| 70518-2614 | Gabapentin | Gabapentin | REMEDYREPACK INC. | ANDA | Current |
| 70518-2614 | Gabapentin | Gabapentin | REMEDYREPACK INC. | ANDA | Current |
| 70518-2614 | Gabapentin | Gabapentin | REMEDYREPACK INC. | ANDA | Current |
| 70518-2614 | Gabapentin | Gabapentin | REMEDYREPACK INC. | ANDA | Current |
| 70518-2614 | Gabapentin | Gabapentin | REMEDYREPACK INC. | ANDA | Current |
| 70518-2614 | Gabapentin | Gabapentin | REMEDYREPACK INC. | ANDA | Current |
| 70518-3329 | Gabapentin | Gabapentin | REMEDYREPACK INC. | ANDA | Current |
| 70518-3329 | Gabapentin | Gabapentin | REMEDYREPACK INC. | ANDA | Current |
| 70518-3330 | Gabapentin | Gabapentin | REMEDYREPACK INC. | ANDA | Current |
| 70934-123 | Gabapentin | Gabapentin | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-123 | Gabapentin | Gabapentin | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-339 | Gabapentin | Gabapentin | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-339 | Gabapentin | Gabapentin | Denton Pharma, Inc. dba Northwind Pharmaceuticals | ANDA | Current |
| 70934-339 | Gabapentin | Gabapentin | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-827 | Gabapentin | Gabapentin | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-953 | Gabapentin | Gabapentin | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 71205-485 | Gabapentin | Gabapentin | Proficient Rx LP | ANDA | Current |
| 71205-485 | Gabapentin | Gabapentin | Proficient Rx LP | ANDA | Current |
| 71335-1197 | Gabapentin | Gabapentin | Bryant Ranch Prepack | ANDA | Current |
| 71335-1197 | Gabapentin | Gabapentin | Bryant Ranch Prepack | ANDA | Current |
| 71335-1197 | Gabapentin | Gabapentin | Bryant Ranch Prepack | ANDA | Current |
| 71335-1198 | Gabapentin | Gabapentin | Bryant Ranch Prepack | ANDA | Current |
| 71335-1198 | Gabapentin | Gabapentin | Bryant Ranch Prepack | ANDA | Current |
| 71335-1198 | Gabapentin | Gabapentin | Bryant Ranch Prepack | ANDA | Current |
| 71335-1199 | Gabapentin | Gabapentin | Bryant Ranch Prepack | ANDA | Current |
| 71335-1199 | Gabapentin | Gabapentin | Bryant Ranch Prepack | ANDA | Current |
| 71335-1199 | Gabapentin | Gabapentin | Bryant Ranch Prepack | ANDA | Current |
| 71335-1269 | Gabapentin | Gabapentin | Bryant Ranch Prepack | ANDA | Current |
| 71335-1269 | Gabapentin | Gabapentin | Bryant Ranch Prepack | ANDA | Current |
| 71335-1269 | Gabapentin | Gabapentin | Bryant Ranch Prepack | ANDA | Current |
| 71335-1269 | Gabapentin | Gabapentin | Bryant Ranch Prepack | ANDA | Current |
| 71335-1496 | Gabapentin | Gabapentin | Bryant Ranch Prepack | ANDA | Current |
| 71335-1496 | Gabapentin | Gabapentin | Bryant Ranch Prepack | ANDA | Current |
| 71335-1496 | Gabapentin | Gabapentin | Bryant Ranch Prepack | ANDA | Current |
| 71335-2053 | Gabapentin | Gabapentin | Bryant Ranch Prepack | ANDA | Current |
| 71335-2053 | Gabapentin | Gabapentin | Bryant Ranch Prepack | ANDA | Current |
| 71335-2053 | Gabapentin | Gabapentin | Bryant Ranch Prepack | ANDA | Current |
| 71610-059 | Gabapentin | Gabapentin | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 71610-143 | Gabapentin | Gabapentin | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 76420-047 | Gabapentin | Gabapentin | Asclemed USA, Inc. | ANDA | Current |
| 76420-047 | Gabapentin | Gabapentin | Asclemed USA, Inc. | ANDA | Current |
| 76420-234 | Gabapentin | Gabapentin | Asclemed USA, Inc. | ANDA | Current |
| 80425-0033 | Neurontin | Gabapentin 300mg | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0033 | Neurontin | Gabapentin 300mg | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0033 | Gabapentin | Gabapentin | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0033 | Gabapentin | Gabapentin | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0033 | Gabapentin | Gabapentin | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0163 | Neurontin | Gabapentin 300mg | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0163 | Gabapentin | Gabapentin | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |