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 | St. Mary's Medical Park Pharmacy | b8b7e045-a7fe-8539-e053-2a95a90a40f8 | 2026-05-01 | Warnings, Adverse reactions | 204989 ANDA204989 |
| Gabapentin | GABAPENTIN | Preferred Pharmaceuticals Inc. | 100ff86c-56a8-4770-9db3-b9bc6b1bd2f7 | 2026-04-30 | Warnings, Adverse reactions | 204989 ANDA204989 |
| Gabapentin | GABAPENTIN | Preferred Pharmaceuticals Inc. | e3429322-c442-4146-bb68-bcc3a8d01552 | 2026-04-29 | Warnings, Adverse reactions | 204989 ANDA204989 |
| Gabapentin | GABAPENTIN | Preferred Pharmaceuticals Inc. | 2625c0ef-5295-41de-9e81-88001a6cbecc | 2026-04-29 | Warnings, Adverse reactions | 204989 ANDA204989 |
| Gabapentin | GABAPENTIN | Preferred Pharmaceuticals, Inc. | 41dcc917-68d1-49f0-8223-44c21ca259ef | 2026-04-29 | Warnings, Adverse reactions | 204989 ANDA204989 |
| Gabapentin | GABAPENTIN | Coupler LLC | 5073abda-321f-29d1-e063-6394a90a59ac | 2026-04-27 | Warnings, Adverse reactions | 204989 ANDA204989 |
| Gabapentin | GABAPENTIN | PHOENIX RX LLC | 4f95c01f-200e-bfd7-e063-6394a90abc38 | 2026-04-16 | Warnings, Adverse reactions | 204989 ANDA204989 |
| RELGAABI | GABAPENTIN | Method Pharmaceuticals, LLC | 4cc6615b-5447-9c0e-e063-6394a90a2883 | 2026-04-08 | Warnings, Adverse reactions | 204989 ANDA204989 |
| Gabapentin | GABAPENTIN | A-S Medication Solutions | 54c09aa5-6724-480a-a115-c88484e39e93 | 2026-02-24 | Warnings, Adverse reactions | 204989 ANDA204989 |
| Gabapentin | GABAPENTIN | Preferred Pharmaceuticals, Inc. | bff3beea-1f05-4e84-bcd2-d05782acddae | 2026-01-14 | Warnings, Adverse reactions | 204989 ANDA204989 |
| Gabapentin | GABAPENTIN | A-S Medication Solutions | 25befbfa-5125-4363-8306-f862e81c0a6f | 2025-10-28 | Warnings, Adverse reactions | 204989 ANDA204989 |
| Gabapentin | GABAPENTIN | A-S Medication Solutions | 1ead7343-ab25-41b5-af4f-f903470e1dd9 | 2025-10-10 | Warnings, Adverse reactions | 204989 ANDA204989 |
| Gabapentin | GABAPENTIN | A-S Medication Solutions | 781b0d62-a760-4371-8908-1f61329928a6 | 2025-10-10 | Warnings, Adverse reactions | 204989 ANDA204989 |
| Gabapentin | GABAPENTIN | Direct_Rx | ed9cb5fe-7a2e-e0bc-e053-2a95a90a4470 | 2025-01-22 | Warnings, Adverse reactions | 204989 ANDA204989 |
| Gabapentin | GABAPENTIN | Preferred Pharmaceuticals Inc. | db57e37f-0a78-4c14-8768-a28bbf9fa0da | 2025-01-21 | Warnings, Adverse reactions | 204989 ANDA204989 |
| Gabapentin | GABAPENTIN | NuCare Pharmaceuticals,Inc. | bd5c9279-a1e3-2a59-e053-2a95a90a33a2 | 2025-01-14 | Warnings, Adverse reactions | 204989 ANDA204989 |
| Gabapentin | GABAPENTIN | Aphena Pharma Solutions - Tennessee, LLC | 41ce952c-6c16-4b5d-adf7-9ea114e63eb3 | 2025-01-09 | Warnings, Adverse reactions | 204989 ANDA204989 |
| Gabapentin | GABAPENTIN | Aphena Pharma Solutions - Tennessee, LLC | 13b87441-8fe1-40f5-8ffb-00dcd8cc90a6 | 2025-01-09 | Warnings, Adverse reactions | 204989 ANDA204989 |
| Gabapentin | GABAPENTIN | Aphena Pharma Solutions - Tennessee, LLC | 95757436-2093-41cf-a9a9-ef2f28ac096f | 2025-01-09 | Warnings, Adverse reactions | 204989 ANDA204989 |
| Gabapentin | GABAPENTIN | Advanced Rx of Tennessee, LLC | d294f6aa-ed82-90a2-e053-2995a90a2896 | 2024-12-31 | 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 |
|---|---|---|---|---|---|
| 10135-644 | Gabapentin | Gabapentin | Marlex Pharmaceuticals Inc | ANDA | Current |
| 10135-644 | Gabapentin | Gabapentin | Marlex Pharmaceuticals Inc | ANDA | Current |
| 10135-645 | Gabapentin | Gabapentin | Marlex Pharmaceuticals Inc | ANDA | Current |
| 10135-645 | Gabapentin | Gabapentin | Marlex Pharmaceuticals Inc | ANDA | Current |
| 10135-646 | Gabapentin | Gabapentin | Marlex Pharmaceuticals Inc | ANDA | Current |
| 10135-646 | Gabapentin | Gabapentin | Marlex Pharmaceuticals Inc | ANDA | Current |
| 43063-758 | GABAPENTIN | GABAPENTIN | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-758 | GABAPENTIN | GABAPENTIN | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-758 | GABAPENTIN | GABAPENTIN | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-758 | GABAPENTIN | GABAPENTIN | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-759 | GABAPENTIN | GABAPENTIN | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-759 | GABAPENTIN | GABAPENTIN | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-759 | GABAPENTIN | GABAPENTIN | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-759 | GABAPENTIN | GABAPENTIN | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-760 | GABAPENTIN | GABAPENTIN | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-760 | GABAPENTIN | GABAPENTIN | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-760 | GABAPENTIN | GABAPENTIN | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-760 | GABAPENTIN | GABAPENTIN | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-760 | GABAPENTIN | GABAPENTIN | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-775 | GABAPENTIN | GABAPENTIN | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43547-383 | GABAPENTIN | GABAPENTIN | Solco Healthcare U.S., LLC | ANDA | Current |
| 43547-383 | GABAPENTIN | GABAPENTIN | Solco Healthcare U.S., LLC | ANDA | Current |
| 43547-383 | GABAPENTIN | GABAPENTIN | Solco Healthcare U.S., LLC | ANDA | Current |
| 43547-384 | GABAPENTIN | GABAPENTIN | Solco Healthcare U.S., LLC | ANDA | Current |
| 43547-384 | GABAPENTIN | GABAPENTIN | Solco Healthcare U.S., LLC | ANDA | Current |
| 43547-384 | GABAPENTIN | GABAPENTIN | Solco Healthcare U.S., LLC | ANDA | Current |
| 43547-385 | GABAPENTIN | GABAPENTIN | Solco Healthcare U.S., LLC | ANDA | Current |
| 43547-385 | GABAPENTIN | GABAPENTIN | Solco Healthcare U.S., LLC | ANDA | Current |
| 43547-385 | GABAPENTIN | GABAPENTIN | Solco Healthcare U.S., LLC | ANDA | Current |
| 50228-179 | Gabapentin | Gabapentin | ScieGen Pharmaceuticals, Inc. | ANDA | Current |
| 50228-179 | Gabapentin | Gabapentin | ScieGen Pharmaceuticals, Inc. | ANDA | Current |
| 50228-179 | Gabapentin | Gabapentin | ScieGen Pharmaceuticals, Inc. | ANDA | Current |
| 50228-179 | Gabapentin | Gabapentin | ScieGen Pharmaceuticals, Inc. | ANDA | Current |
| 50228-179 | Gabapentin | Gabapentin | ScieGen Pharmaceuticals, Inc. | ANDA | Current |
| 50228-179 | Gabapentin | Gabapentin | ScieGen Pharmaceuticals, Inc. | ANDA | Current |
| 50228-180 | Gabapentin | Gabapentin | ScieGen Pharmaceuticals, Inc. | ANDA | Current |
| 50228-180 | Gabapentin | Gabapentin | ScieGen Pharmaceuticals, Inc. | ANDA | Current |
| 50228-180 | Gabapentin | Gabapentin | ScieGen Pharmaceuticals, Inc. | ANDA | Current |
| 50228-180 | Gabapentin | Gabapentin | ScieGen Pharmaceuticals, Inc. | ANDA | Current |
| 50228-180 | Gabapentin | Gabapentin | ScieGen Pharmaceuticals, Inc. | ANDA | Current |
| 50228-180 | Gabapentin | Gabapentin | ScieGen Pharmaceuticals, Inc. | ANDA | Current |
| 50228-181 | Gabapentin | Gabapentin | ScieGen Pharmaceuticals, Inc. | ANDA | Current |
| 50228-181 | Gabapentin | Gabapentin | ScieGen Pharmaceuticals, Inc. | ANDA | Current |
| 50228-181 | Gabapentin | Gabapentin | ScieGen Pharmaceuticals, Inc. | ANDA | Current |
| 50228-181 | Gabapentin | Gabapentin | ScieGen Pharmaceuticals, Inc. | ANDA | Current |
| 50228-181 | Gabapentin | Gabapentin | ScieGen Pharmaceuticals, Inc. | ANDA | Current |
| 50228-181 | Gabapentin | Gabapentin | ScieGen Pharmaceuticals, Inc. | ANDA | Current |
| 50436-0383 | GABAPENTIN | GABAPENTIN | Unit Dose Services | ANDA | Current |
| 50436-0383 | GABAPENTIN | GABAPENTIN | Unit Dose Services | ANDA | Current |
| 50436-0383 | GABAPENTIN | GABAPENTIN | Unit Dose Services | ANDA | Current |
| 50436-0384 | GABAPENTIN | GABAPENTIN | Unit Dose Services | ANDA | Current |
| 50436-0384 | GABAPENTIN | GABAPENTIN | Unit Dose Services | ANDA | Current |
| 50436-0384 | GABAPENTIN | GABAPENTIN | Unit Dose Services | ANDA | Current |
| 51407-047 | Gabapentin | Gabapentin | Golden State Medical Supply Inc. | ANDA | Current |
| 51407-047 | Gabapentin | Gabapentin | Golden State Medical Supply | ANDA | Current |
| 51407-047 | Gabapentin | Gabapentin | Golden State Medical Supply | ANDA | Current |
| 51407-047 | Gabapentin | Gabapentin | Golden State Medical Supply, Inc. | ANDA | Current |
| 51407-047 | Gabapentin | Gabapentin | Golden State Medical Supply, Inc. | ANDA | Current |
| 51407-047 | Gabapentin | Gabapentin | Golden State Medical Supply, Inc. | ANDA | Current |
| 51407-048 | Gabapentin | Gabapentin | Golden State Medical Supply Inc. | ANDA | Current |
| 51407-048 | Gabapentin | Gabapentin | Golden State Medical Supply | ANDA | Current |
| 51407-048 | Gabapentin | Gabapentin | Golden State Medical Supply | ANDA | Current |
| 51407-048 | Gabapentin | Gabapentin | Golden State Medical Supply, Inc. | ANDA | Current |
| 51407-048 | Gabapentin | Gabapentin | Golden State Medical Supply, Inc. | ANDA | Current |
| 51407-048 | Gabapentin | Gabapentin | Golden State Medical Supply, Inc. | ANDA | Current |
| 51407-049 | Gabapentin | Gabapentin | Golden State Medical Supply Inc. | ANDA | Current |
| 51407-049 | Gabapentin | Gabapentin | Golden State Medical Supply | ANDA | Current |
| 51407-049 | Gabapentin | Gabapentin | Golden State Medical Supply | ANDA | Current |
| 51407-049 | Gabapentin | Gabapentin | Golden State Medical Supply, Inc. | ANDA | Current |
| 51407-049 | Gabapentin | Gabapentin | Golden State Medical Supply, Inc. | ANDA | Current |
| 51407-049 | Gabapentin | Gabapentin | Golden State Medical Supply, Inc. | ANDA | Current |
| 53002-5472 | Gabapentin | Gabapentin | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-6423 | Gabapentin | Gabapentin | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 55700-763 | Gabapentin | Gabapentin | Quality Care Products, LLC | ANDA | Current |
| 55700-949 | Gabapentin | Gabapentin | Quality Care Products, LLC | ANDA | Current |
| 55700-949 | Gabapentin | Gabapentin | Quality Care Products, LLC | ANDA | Current |
| 55700-949 | Gabapentin | Gabapentin | Quality Care Products, LLC | ANDA | Current |
| 55700-950 | Gabapentin | Gabapentin | Quality Care Products, LLC | ANDA | Current |
| 55700-950 | Gabapentin | Gabapentin | Quality Care Products, LLC | ANDA | Current |
| 55700-950 | Gabapentin | Gabapentin | Quality Care Products, LLC | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 10412 | ORIG | 2016-02-22 |