Application 075360
- Type
- ANDA
- Sponsor
- GRANULES INDIA 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 |
|---|---|---|---|---|---|---|---|
| A075360-001 | GABAPENTIN | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2005-04-06 | |
| A075360-002 | GABAPENTIN | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2005-04-06 | |
| A075360-003 | GABAPENTIN | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2005-04-06 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A075360-001 | AB |
| A075360-002 | AB |
| A075360-003 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A075360-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2005-04-06 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A075360-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2005-04-06 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A075360-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2005-04-06 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A075360-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2005-04-06 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A075360-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2005-04-06 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A075360-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2005-04-06 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075360-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2005-04-06 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075360-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2005-04-06 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075360-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2005-04-06 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075360-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2005-04-06 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075360-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2005-04-06 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075360-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2005-04-06 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075360-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2005-04-06 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075360-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2005-04-06 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075360-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2005-04-06 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075360-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2005-04-06 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075360-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2005-04-06 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075360-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2005-04-06 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075360-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2005-04-06 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075360-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2005-04-06 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075360-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2005-04-06 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075360-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2005-04-06 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075360-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2005-04-06 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075360-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2005-04-06 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075360-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2005-04-06 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075360-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2005-04-06 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075360-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2005-04-06 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075360-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2005-04-06 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075360-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2005-04-06 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075360-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2005-04-06 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A075360-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2005-04-06 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A075360-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2005-04-06 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A075360-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2005-04-06 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075360-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2005-04-06 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075360-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2005-04-06 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075360-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2005-04-06 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075360-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2005-04-06 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075360-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2005-04-06 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075360-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2005-04-06 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075360-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2005-04-06 | 1e350fbaab3a… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A075360-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A075360-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A075360-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A075360-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A075360-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A075360-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075360-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075360-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075360-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A075360-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A075360-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A075360-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075360-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075360-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075360-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075360-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075360-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075360-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075360-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075360-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075360-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075360-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075360-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075360-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075360-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075360-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075360-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075360-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075360-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075360-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A075360-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A075360-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A075360-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075360-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075360-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075360-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075360-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075360-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075360-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075360-001 | AB | 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 | Granules Pharmaceuticals Inc | c681c804-c6f3-d63b-e053-2995a90a6b8f | 2026-06-17 | Warnings, Adverse reactions | 075360 ANDA075360 70010-927 70010-926 70010-928 |
| GABAPENTIN | GABAPENTIN | Bryant Ranch Prepack | 397fd6d3-317b-4b61-a52b-3a09ca1d88a4 | 2026-05-22 | Warnings, Adverse reactions | 075360 ANDA075360 71335-1997 |
| GABAPENTIN | GABAPENTIN | Bryant Ranch Prepack | 13640281-26b4-402e-8f69-7c81cd6e0376 | 2026-05-22 | Warnings, Adverse reactions | 075360 ANDA075360 71335-2004 |
| GABAPENTIN | GABAPENTIN | ST. MARY'S MEDICAL PARK PHARMACY | 3aaf3d6e-c6d5-89f5-e063-6394a90a9b77 | 2025-12-29 | Warnings, Adverse reactions | 075360 ANDA075360 |
| GABAPENTIN | GABAPENTIN | Granules Pharmaceuticals Inc. | b20ee34a-7f2d-4d62-a161-898565f74547 | 2025-12-02 | Warnings, Adverse reactions | 075360 ANDA075360 70010-118 70010-108 70010-109 |
| Gabapentin | GABAPENTIN | Advanced Rx Pharmacy of Tennessee, LLC | c859e666-d510-426b-e053-2995a90a9a3c | 2024-12-31 | Warnings, Adverse reactions | 075360 ANDA075360 80425-0150 |
| GABAPENTIN | GABAPENTIN | Asclemed USA, Inc. | 5fb79774-c2d4-47ba-9a16-eb367d0fdcff | 2023-09-30 | Warnings, Adverse reactions | 075360 ANDA075360 |
| GABAPENTIN | GABAPENTIN | Proficient Rx LP | aa3ab216-372a-4a72-bfd1-88a1ffa31ba3 | 2022-05-01 | Warnings, Adverse reactions | 075360 ANDA075360 71205-661 |
| GABAPENTIN | GABAPENTIN | Proficient Rx LP | 185f264e-db32-41cd-b90d-519717b97850 | 2021-11-01 | Warnings, Adverse reactions | 075360 ANDA075360 71205-619 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0904-5631 | Gabapentin | Gabapentin | Major Pharmaceuticals | ANDA | Current |
| 0904-5632 | Gabapentin | Gabapentin | Major Pharmaceuticals | ANDA | Current |
| 0904-5633 | Gabapentin | Gabapentin | Major Pharmaceuticals | ANDA | Current |
| 10544-436 | Gabapentin | Gabapentin | Blenheim Pharmacal, Inc. | ANDA | Current |
| 10544-447 | Gabapentin | Gabapentin | Blenheim Pharmacal, Inc. | ANDA | Current |
| 21695-055 | Gabapentin | Gabapentin | Rebel Distributors Corp. | ANDA | Current |
| 21695-056 | Gabapentin | Gabapentin | Rebel Distributors Corp. | ANDA | Current |
| 21695-344 | Gabapentin | Gabapentin | Rebel Distributors Corp. | ANDA | Current |
| 50090-1681 | Gabapentin | Gabapentin | A-S Medication Solutions | ANDA | Current |
| 50090-2590 | Gabapentin | Gabapentin | A-S Medication Solutions | ANDA | Current |
| 50090-2794 | Gabapentin | Gabapentin | A-S Medication Solutions | ANDA | Current |
| 55154-1379 | Gabapentin | Gabapentin | Cardinal Health | ANDA | Current |
| 55700-299 | Gabapentin | Gabapentin | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 60505-0112 | Gabapentin | Gabapentin | Apotex Corp. | ANDA | Current |
| 60505-0112 | Gabapentin | Gabapentin | Apotex Corp. | ANDA | Current |
| 60505-0112 | Gabapentin | Gabapentin | Apotex Corp. | ANDA | Current |
| 60505-0112 | Gabapentin | Gabapentin | Apotex Corp. | ANDA | Current |
| 60505-0112 | Gabapentin | Gabapentin | Apotex Corp. | ANDA | Current |
| 60505-0113 | Gabapentin | Gabapentin | Apotex Corp. | ANDA | Current |
| 60505-0113 | Gabapentin | Gabapentin | Apotex Corp. | ANDA | Current |
| 60505-0113 | Gabapentin | Gabapentin | Apotex Corp. | ANDA | Current |
| 60505-0113 | Gabapentin | Gabapentin | Apotex Corp. | ANDA | Current |
| 60505-0113 | Gabapentin | Gabapentin | Apotex Corp. | ANDA | Current |
| 60505-0114 | Gabapentin | Gabapentin | Apotex Corp. | ANDA | Current |
| 60505-0114 | Gabapentin | Gabapentin | Apotex Corp. | ANDA | Current |
| 60505-0114 | Gabapentin | Gabapentin | Apotex Corp. | ANDA | Current |
| 60505-0114 | Gabapentin | Gabapentin | Apotex Corp. | ANDA | Current |
| 60505-0114 | Gabapentin | Gabapentin | Apotex Corp. | ANDA | Current |
| 62207-922 | GABAPENTIN | GABAPENTIN | Granules India Limited | ANDA | Current |
| 62207-922 | GABAPENTIN | GABAPENTIN | Granules India Limited | ANDA | Current |
| 62207-923 | GABAPENTIN | GABAPENTIN | Granules India Limited | ANDA | Current |
| 62207-923 | GABAPENTIN | GABAPENTIN | Granules India Limited | ANDA | Current |
| 62207-924 | GABAPENTIN | GABAPENTIN | Granules India Limited | ANDA | Current |
| 62207-924 | GABAPENTIN | GABAPENTIN | Granules India Limited | ANDA | Current |
| 62207-926 | GABAPENTIN | GABAPENTIN | Granules India Limited | ANDA | Current |
| 62207-926 | GABAPENTIN | GABAPENTIN | Granules India Limited | ANDA | Current |
| 62207-927 | GABAPENTIN | GABAPENTIN | Granules India Limited | ANDA | Current |
| 62207-927 | GABAPENTIN | GABAPENTIN | Granules India Limited | ANDA | Current |
| 62207-928 | GABAPENTIN | GABAPENTIN | Granules India Limited | ANDA | Current |
| 62207-928 | GABAPENTIN | GABAPENTIN | Granules India Limited | ANDA | Current |
| 63629-6983 | Gabapentin | Gabapentin | Bryant Ranch Prepack | ANDA | Current |
| 63629-6983 | Gabapentin | Gabapentin | Bryant Ranch Prepack | ANDA | Current |
| 68151-1028 | Gabapentin | Gabapentin | Carilion Materials Management | ANDA | Current |
| 68788-8176 | GABAPENTIN | GABAPENTIN | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 70010-108 | GABAPENTIN | GABAPENTIN | Granules Pharmaceuticals Inc. | ANDA | Current |
| 70010-108 | GABAPENTIN | GABAPENTIN | Granules Pharmaceuticals Inc. | ANDA | Current |
| 70010-109 | GABAPENTIN | GABAPENTIN | Granules Pharmaceuticals Inc. | ANDA | Current |
| 70010-109 | GABAPENTIN | GABAPENTIN | Granules Pharmaceuticals Inc. | ANDA | Current |
| 70010-118 | GABAPENTIN | GABAPENTIN | Granules Pharmaceuticals Inc. | ANDA | Current |
| 70010-118 | GABAPENTIN | GABAPENTIN | Granules Pharmaceuticals Inc. | ANDA | Current |
| 70010-926 | GABAPENTIN | GABAPENTIN | Granules Pharmaceuticals Inc | ANDA | Current |
| 70010-926 | GABAPENTIN | GABAPENTIN | Granules Pharmaceuticals Inc | ANDA | Current |
| 70010-927 | GABAPENTIN | GABAPENTIN | Granules Pharmaceuticals Inc | ANDA | Current |
| 70010-927 | GABAPENTIN | GABAPENTIN | Granules Pharmaceuticals Inc | ANDA | Current |
| 70010-928 | GABAPENTIN | GABAPENTIN | Granules Pharmaceuticals Inc | ANDA | Current |
| 70010-928 | GABAPENTIN | GABAPENTIN | Granules Pharmaceuticals Inc | ANDA | Current |
| 71205-619 | GABAPENTIN | GABAPENTIN | Proficient Rx LP | ANDA | Current |
| 71205-661 | GABAPENTIN | GABAPENTIN | Proficient Rx LP | ANDA | Current |
| 71335-1997 | GABAPENTIN | GABAPENTIN | Bryant Ranch Prepack | ANDA | Current |
| 71335-1997 | GABAPENTIN | GABAPENTIN | Bryant Ranch Prepack | ANDA | Current |
| 71335-2004 | GABAPENTIN | GABAPENTIN | Bryant Ranch Prepack | ANDA | Current |
| 71335-2004 | GABAPENTIN | GABAPENTIN | Bryant Ranch Prepack | ANDA | Current |
| 80425-0150 | Neurontin | Gabapentin 100mg | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0150 | Neurontin | Gabapentin 100mg | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0150 | Gabapentin | Gabapentin | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0150 | Gabapentin | Gabapentin | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0150 | Gabapentin | Gabapentin | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 42984 | ORIG | 2007-07-06 |