Application 204989
- Type
- ANDA
- Sponsor
- SCIEGEN PHARMS INC
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 |
| 004 | RELGAABI | GABAPENTIN | CAPSULE;ORAL | 200MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A204989-001 | RELGAABI | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2016-02-18 | |
| A204989-002 | RELGAABI | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2016-02-18 | |
| A204989-003 | RELGAABI | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2016-02-18 | |
| A204989-004 | RELGAABI | GABAPENTIN | 200MG | CAPSULE / ORAL | AB | 2026-03-06 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A204989-001 | AB |
| A204989-002 | AB |
| A204989-003 | AB |
| A204989-004 | 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 | A204989-001 | RELGAABI | 100MG | CAPSULE / ORAL | AB | 2016-02-18 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A204989-002 | RELGAABI | 300MG | CAPSULE / ORAL | AB | 2016-02-18 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A204989-003 | RELGAABI | 400MG | CAPSULE / ORAL | AB | 2016-02-18 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A204989-004 | RELGAABI | 200MG | CAPSULE / ORAL | AB | 2026-03-06 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A204989-001 | RELGAABI | 100MG | CAPSULE / ORAL | AB | 2016-02-18 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A204989-002 | RELGAABI | 300MG | CAPSULE / ORAL | AB | 2016-02-18 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A204989-003 | RELGAABI | 400MG | CAPSULE / ORAL | AB | 2016-02-18 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A204989-004 | RELGAABI | 200MG | CAPSULE / ORAL | AB | 2026-03-06 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A204989-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2016-02-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A204989-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2016-02-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A204989-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2016-02-18 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204989-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2016-02-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204989-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2016-02-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204989-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2016-02-18 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A204989-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2016-02-18 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A204989-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2016-02-18 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A204989-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2016-02-18 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204989-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2016-02-18 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204989-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2016-02-18 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204989-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2016-02-18 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204989-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2016-02-18 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204989-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2016-02-18 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204989-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2016-02-18 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204989-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2016-02-18 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204989-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2016-02-18 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204989-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2016-02-18 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204989-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2016-02-18 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204989-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2016-02-18 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204989-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2016-02-18 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204989-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2016-02-18 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204989-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2016-02-18 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204989-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2016-02-18 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204989-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2016-02-18 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204989-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2016-02-18 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204989-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2016-02-18 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A204989-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2016-02-18 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A204989-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2016-02-18 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A204989-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2016-02-18 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A204989-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2016-02-18 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A204989-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2016-02-18 | 79d66fd596c7… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A204989-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A204989-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A204989-003 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A204989-004 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A204989-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A204989-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A204989-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A204989-004 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A204989-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A204989-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A204989-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204989-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204989-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204989-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A204989-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A204989-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A204989-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204989-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204989-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204989-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204989-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204989-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204989-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204989-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204989-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204989-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204989-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204989-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204989-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204989-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204989-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204989-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204989-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204989-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204989-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A204989-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A204989-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A204989-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A204989-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A204989-002 | AB | 1 | 79d66fd596c7… |
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 | NuCare Pharmaceuticals,Inc. | d35cd5ac-5ed6-2405-e053-2995a90a6946 | 2026-09-03 | Warnings, Adverse reactions | 204989 ANDA204989 68071-2600 |
| Gabapentin | GABAPENTIN | Bryant Ranch Prepack | 1af098ad-28b5-463f-8efa-24d70a77d64c | 2026-08-26 | Warnings, Adverse reactions | 204989 ANDA204989 |
| Gabapentin | GABAPENTIN | Bryant Ranch Prepack | 9a2658d5-9b0e-4921-b4c5-4c89f1630d69 | 2026-08-26 | Warnings, Adverse reactions | 204989 ANDA204989 |
| Gabapentin | GABAPENTIN | Bryant Ranch Prepack | 43cbff48-8219-41ba-b67d-3ae4544b78bb | 2026-08-26 | Warnings, Adverse reactions | 204989 ANDA204989 |
| Gabapentin | GABAPENTIN | Trifluent Pharma, LLC | 59442de1-7cf0-35f6-e063-6294a90a57d7 | 2026-08-17 | Warnings, Adverse reactions | 204989 ANDA204989 |
| Gabapentin | GABAPENTIN | Bryant Ranch Prepack | cb81fd89-b32b-4538-bf5c-ab02f65b3458 | 2026-08-07 | Warnings, Adverse reactions | 204989 ANDA204989 63629-8485 |
| Gabapentin | GABAPENTIN | Bryant Ranch Prepack | 691205ba-fa65-4bc9-ba20-7d361382cff9 | 2026-08-07 | Warnings, Adverse reactions | 204989 ANDA204989 63629-8486 |
| Gabapentin | GABAPENTIN | Bryant Ranch Prepack | 97e47698-97c9-4eb5-a108-5850c2aa2818 | 2026-08-07 | Warnings, Adverse reactions | 204989 ANDA204989 63629-8484 |
| Gabapentin | GABAPENTIN | Bryant Ranch Prepack | 2ac0622c-440a-49a0-974f-726e6ac72a0e | 2026-08-07 | Warnings, Adverse reactions | 204989 ANDA204989 63629-8487 |
| Gabapentin | GABAPENTIN | Bryant Ranch Prepack | 48037fc4-1aab-4ae8-aede-7c55b494877a | 2026-08-07 | Warnings, Adverse reactions | 204989 ANDA204989 63629-8488 |
| Gabapentin | GABAPENTIN | REMEDYREPACK INC. | e877a425-2b7f-4e43-a1f9-24019cbf9685 | 2026-07-31 | Warnings, Adverse reactions | 204989 ANDA204989 70518-2970 |
| Gabapentin | GABAPENTIN | ScieGen Pharmaceuticals, Inc. | 16542ee6-0e0e-4d3c-8b32-60ff6ef48846 | 2026-07-21 | Warnings, Adverse reactions | 204989 ANDA204989 |
| Gabapentin | GABAPENTIN | PD-Rx Pharmaceuticals, Inc. | 4a95f18e-0de4-4ce1-9f97-bc2e8a5bac6a | 2026-07-17 | Warnings, Adverse reactions | 204989 ANDA204989 |
| Gabapentin | GABAPENTIN | HAWAII REPACK, INC. | dd7adad2-e2f5-4b43-90a4-522bce0be5b3 | 2026-07-02 | Warnings, Adverse reactions | 204989 ANDA204989 |
| Gabapentin | GABAPENTIN | Northwind Health Company, LLC | 1b44a3ab-4d06-205f-e063-6294a90af368 | 2026-06-22 | Warnings, Adverse reactions | 204989 ANDA204989 |
| Gabapentin | GABAPENTIN | Asclemed USA, Inc. | 9a829dc3-b2d8-4d19-a579-0597217cec9b | 2026-06-17 | Warnings, Adverse reactions | 204989 ANDA204989 |
| Gabapentin | GABAPENTIN | St. Mary's Medical Park Pharmacy | b7a29b99-ce23-950e-e053-2995a90a1934 | 2026-06-09 | Warnings, Adverse reactions | 204989 ANDA204989 60760-741 |
| Gabapentin | GABAPENTIN | Bryant Ranch Prepack | 4c49d34d-bb47-406b-8f2d-b4834b2ee9d0 | 2026-06-08 | Warnings, Adverse reactions | 204989 ANDA204989 |
| Gabapentin | GABAPENTIN | Coupler LLC | 5385e27c-f2fa-32d5-e063-6294a90a0a8c | 2026-06-05 | Warnings, Adverse reactions | 204989 ANDA204989 |
| Gabapentin | GABAPENTIN | Direct_Rx | f8998c1c-c359-6f01-e053-6294a90aebf4 | 2026-06-01 | Warnings, Adverse reactions | 204989 ANDA204989 |
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 |
|---|---|---|---|---|---|
| 58657-620 | GABAPENTIN | GABAPENTIN | Method Pharmaceuticals, LLC | ANDA | Current |
| 58657-621 | GABAPENTIN | GABAPENTIN | Method Pharmaceuticals, LLC | ANDA | Current |
| 58657-622 | GABAPENTIN | GABAPENTIN | Method Pharmaceuticals, LLC | ANDA | Current |
| 59088-736 | GPL Pak | GABAPENTIN, LIDOCAINE HYDROCHLORIDE | PureTek Corporation | ANDA | Current |
| 59088-738 | Gabacaine | GABAPENTIN, LIDOCAINE | PureTek Corporation | ANDA | Current |
| 59088-739 | Prilopentin | GABAPENTIN, LIDOCAINE AND PRILOCAINE | PureTek Corporation | ANDA | Current |
| 59088-743 | Lido GB-300 | GABAPENTIN, LIDOCAINE HYDROCHLORIDE | PureTek Corporation | ANDA | Current |
| 59088-747 | GABAPAL | GABAPENTIN, LIDOCAINE HYDROCHLORIDE | PureTek Corporation | ANDA | Current |
| 59088-749 | Lidotin | GABAPENTIN, LIDOCAINE HYDROCHLORIDE | PureTek Corporation | ANDA | Current |
| 59088-750 | Pentican | GABAPENTIN, LIDOCAINE | PureTek Corporation | ANDA | Current |
| 59088-753 | Lipritin | GABAPENTIN, LIDOCAINE AND PRILOCAINE | PureTek Corporation | ANDA | Current |
| 59088-761 | Lipritin II | GABAPENTIN, LIDOCAINE AND PRILOCAINE | PureTek Corporation | ANDA | Current |
| 59088-765 | Prilopentin -II | GABAPENTIN, LIDOCAINE AND PRILOCAINE | PureTek Corporation | ANDA | Current |
| 60760-383 | GABAPENTIN | GABAPENTIN | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 60760-565 | GABAPENTIN | GABAPENTIN | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 60760-740 | Gabapentin | Gabapentin | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 60760-740 | Gabapentin | Gabapentin | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 60760-741 | Gabapentin | Gabapentin | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 61919-661 | GABAPENTIN | GABAPENTIN | DIRECT RX | ANDA | Current |
| 63187-983 | GABAPENTIN | GABAPENTIN | Proficient Rx LP | ANDA | Current |
| 63187-983 | GABAPENTIN | GABAPENTIN | Proficient Rx LP | ANDA | Current |
| 63629-8484 | Gabapentin | Gabapentin | Bryant Ranch Prepack | ANDA | Current |
| 63629-8484 | Gabapentin | Gabapentin | Bryant Ranch Prepack | ANDA | Current |
| 63629-8484 | Gabapentin | Gabapentin | Bryant Ranch Prepack | ANDA | Current |
| 63629-8485 | Gabapentin | Gabapentin | Bryant Ranch Prepack | ANDA | Current |
| 63629-8485 | Gabapentin | Gabapentin | Bryant Ranch Prepack | ANDA | Current |
| 63629-8485 | Gabapentin | Gabapentin | Bryant Ranch Prepack | ANDA | Current |
| 63629-8486 | Gabapentin | Gabapentin | Bryant Ranch Prepack | ANDA | Current |
| 63629-8486 | Gabapentin | Gabapentin | Bryant Ranch Prepack | ANDA | Current |
| 63629-8486 | Gabapentin | Gabapentin | Bryant Ranch Prepack | ANDA | Current |
| 63629-8487 | Gabapentin | Gabapentin | Bryant Ranch Prepack | ANDA | Current |
| 63629-8487 | Gabapentin | Gabapentin | Bryant Ranch Prepack | ANDA | Current |
| 63629-8487 | Gabapentin | Gabapentin | Bryant Ranch Prepack | ANDA | Current |
| 63629-8488 | Gabapentin | Gabapentin | Bryant Ranch Prepack | ANDA | Current |
| 63629-8488 | Gabapentin | Gabapentin | Bryant Ranch Prepack | ANDA | Current |
| 63629-8488 | Gabapentin | Gabapentin | Bryant Ranch Prepack | ANDA | Current |
| 67296-1557 | GABAPENTIN | GABAPENTIN | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1557 | GABAPENTIN | GABAPENTIN | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1777 | Gabapentin | Gabapentin | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1777 | Gabapentin | Gabapentin | RedPharm Drug, Inc. | ANDA | Current |
| 68071-2308 | Gabapentin | Gabapentin | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-2308 | Gabapentin | Gabapentin | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-2308 | Gabapentin | Gabapentin | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-2308 | Gabapentin | Gabapentin | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-2366 | Gabapentin | Gabapentin | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-2458 | Gabapentin | Gabapentin | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-2600 | Gabapentin | Gabapentin | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4402 | GABAPENTIN | GABAPENTIN | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4402 | GABAPENTIN | GABAPENTIN | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4402 | GABAPENTIN | GABAPENTIN | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68788-7822 | Gabapentin | Gabapentin | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7822 | Gabapentin | Gabapentin | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7822 | Gabapentin | Gabapentin | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7838 | Gabapentin | Gabapentin | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7838 | Gabapentin | Gabapentin | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7839 | Gabapentin | Gabapentin | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7839 | Gabapentin | Gabapentin | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7848 | Gabapentin | Gabapentin | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7848 | Gabapentin | Gabapentin | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 69367-131 | Gabapentin | Gabapentin | Westminster Pharmaceuticals, LLC | ANDA | Current |
| 69367-131 | Gabapentin | Gabapentin | Westminster Pharmaceuticals, LLC | ANDA | Current |
| 69367-131 | Gabapentin | Gabapentin | Westminster Pharmaceuticals, LLC | ANDA | Current |
| 69367-131 | Gabapentin | Gabapentin | Westminster Pharmaceuticals, LLC | ANDA | Current |
| 69367-131 | Gabapentin | Gabapentin | Westminster Pharmaceuticals, LLC | ANDA | Current |
| 69367-131 | Gabapentin | Gabapentin | Westminster Pharmaceuticals, LLC | ANDA | Current |
| 69367-132 | Gabapentin | Gabapentin | Westminster Pharmaceuticals, LLC | ANDA | Current |
| 69367-132 | Gabapentin | Gabapentin | Westminster Pharmaceuticals, LLC | ANDA | Current |
| 69367-132 | Gabapentin | Gabapentin | Westminster Pharmaceuticals, LLC | ANDA | Current |
| 69367-132 | Gabapentin | Gabapentin | Westminster Pharmaceuticals, LLC | ANDA | Current |
| 69367-132 | Gabapentin | Gabapentin | Westminster Pharmaceuticals, LLC | ANDA | Current |
| 69367-132 | Gabapentin | Gabapentin | Westminster Pharmaceuticals, LLC | ANDA | Current |
| 69367-133 | Gabapentin | Gabapentin | Westminster Pharmaceuticals, LLC | ANDA | Current |
| 69367-133 | Gabapentin | Gabapentin | Westminster Pharmaceuticals, LLC | ANDA | Current |
| 69367-133 | Gabapentin | Gabapentin | Westminster Pharmaceuticals, LLC | ANDA | Current |
| 69367-133 | Gabapentin | Gabapentin | Westminster Pharmaceuticals, LLC | ANDA | Current |
| 69367-133 | Gabapentin | Gabapentin | Westminster Pharmaceuticals, LLC | ANDA | Current |
| 69367-133 | Gabapentin | Gabapentin | Westminster Pharmaceuticals, LLC | ANDA | Current |
| 70518-1890 | GABAPENTIN | GABAPENTIN | REMEDYREPACK INC. | ANDA | Current |
| 70518-2970 | Gabapentin | Gabapentin | REMEDYREPACK INC. | ANDA | Current |
| 70518-2970 | Gabapentin | Gabapentin | REMEDYREPACK INC. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 10412 | ORIG | 2016-02-22 |