Application 205101
- Type
- ANDA
- Sponsor
- SCIEGEN PHARMS INC
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 |
|---|---|---|---|---|---|---|---|
| A205101-001 | GABAPENTIN | GABAPENTIN | 600MG | TABLET / ORAL | AB1 | 2016-02-04 | |
| A205101-002 | GABAPENTIN | GABAPENTIN | 800MG | TABLET / ORAL | AB1 | 2016-02-04 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A205101-001 | AB1 |
| A205101-002 | AB1 |
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 | A205101-001 | GABAPENTIN | 600MG | TABLET / ORAL | AB1 | 2016-02-04 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A205101-002 | GABAPENTIN | 800MG | TABLET / ORAL | AB1 | 2016-02-04 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A205101-001 | GABAPENTIN | 600MG | TABLET / ORAL | AB1 | 2016-02-04 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A205101-002 | GABAPENTIN | 800MG | TABLET / ORAL | AB1 | 2016-02-04 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A205101-001 | GABAPENTIN | 600MG | TABLET / ORAL | AB1 | 2016-02-04 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A205101-002 | GABAPENTIN | 800MG | TABLET / ORAL | AB1 | 2016-02-04 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205101-001 | GABAPENTIN | 600MG | TABLET / ORAL | AB1 | 2016-02-04 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205101-002 | GABAPENTIN | 800MG | TABLET / ORAL | AB1 | 2016-02-04 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A205101-001 | GABAPENTIN | 600MG | TABLET / ORAL | AB1 | 2016-02-04 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A205101-002 | GABAPENTIN | 800MG | TABLET / ORAL | AB1 | 2016-02-04 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205101-001 | GABAPENTIN | 600MG | TABLET / ORAL | AB1 | 2016-02-04 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205101-002 | GABAPENTIN | 800MG | TABLET / ORAL | AB1 | 2016-02-04 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205101-001 | GABAPENTIN | 600MG | TABLET / ORAL | AB1 | 2016-02-04 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205101-002 | GABAPENTIN | 800MG | TABLET / ORAL | AB1 | 2016-02-04 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205101-001 | GABAPENTIN | 600MG | TABLET / ORAL | AB1 | 2016-02-04 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205101-002 | GABAPENTIN | 800MG | TABLET / ORAL | AB1 | 2016-02-04 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205101-001 | GABAPENTIN | 600MG | TABLET / ORAL | AB1 | 2016-02-04 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205101-002 | GABAPENTIN | 800MG | TABLET / ORAL | AB1 | 2016-02-04 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A205101-001 | GABAPENTIN | 600MG | TABLET / ORAL | AB1 | 2016-02-04 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A205101-002 | GABAPENTIN | 800MG | TABLET / ORAL | AB1 | 2016-02-04 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A205101-001 | GABAPENTIN | 600MG | TABLET / ORAL | AB1 | 2016-02-04 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A205101-002 | GABAPENTIN | 800MG | TABLET / ORAL | AB1 | 2016-02-04 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A205101-001 | GABAPENTIN | 600MG | TABLET / ORAL | AB1 | 2016-02-04 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A205101-002 | GABAPENTIN | 800MG | TABLET / ORAL | AB1 | 2016-02-04 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A205101-001 | GABAPENTIN | 600MG | TABLET / ORAL | AB1 | 2016-02-04 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A205101-002 | GABAPENTIN | 800MG | TABLET / ORAL | AB1 | 2016-02-04 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A205101-001 | GABAPENTIN | 600MG | TABLET / ORAL | AB1 | 2016-02-04 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A205101-002 | GABAPENTIN | 800MG | TABLET / ORAL | AB1 | 2016-02-04 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A205101-001 | GABAPENTIN | 600MG | TABLET / ORAL | AB1 | 2016-02-04 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A205101-002 | GABAPENTIN | 800MG | TABLET / ORAL | AB1 | 2016-02-04 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A205101-001 | GABAPENTIN | 600MG | TABLET / ORAL | AB1 | 2016-02-04 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A205101-002 | GABAPENTIN | 800MG | TABLET / ORAL | AB1 | 2016-02-04 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A205101-001 | GABAPENTIN | 600MG | TABLET / ORAL | AB | 2016-02-04 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A205101-002 | GABAPENTIN | 800MG | TABLET / ORAL | AB | 2016-02-04 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A205101-001 | GABAPENTIN | 600MG | TABLET / ORAL | AB | 2016-02-04 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A205101-002 | GABAPENTIN | 800MG | TABLET / ORAL | AB | 2016-02-04 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A205101-001 | GABAPENTIN | 600MG | TABLET / ORAL | AB | 2016-02-04 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A205101-002 | GABAPENTIN | 800MG | TABLET / ORAL | AB | 2016-02-04 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A205101-001 | GABAPENTIN | 600MG | TABLET / ORAL | AB | 2016-02-04 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A205101-002 | GABAPENTIN | 800MG | TABLET / ORAL | AB | 2016-02-04 | 74a2ff9319b5… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A205101-001 | AB1 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A205101-002 | AB1 | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A205101-001 | AB1 | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A205101-002 | AB1 | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A205101-001 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A205101-002 | AB1 | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205101-001 | AB1 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205101-002 | AB1 | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A205101-001 | AB1 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A205101-002 | AB1 | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205101-001 | AB1 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205101-002 | AB1 | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205101-001 | AB1 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205101-002 | AB1 | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205101-001 | AB1 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205101-002 | AB1 | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205101-001 | AB1 | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205101-002 | AB1 | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A205101-001 | AB1 | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A205101-002 | AB1 | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A205101-001 | AB1 | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A205101-002 | AB1 | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A205101-001 | AB1 | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A205101-002 | AB1 | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A205101-001 | AB1 | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A205101-002 | AB1 | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A205101-001 | AB1 | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A205101-002 | AB1 | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A205101-001 | AB1 | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A205101-002 | AB1 | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A205101-001 | AB1 | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A205101-002 | AB1 | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A205101-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A205101-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A205101-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A205101-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A205101-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A205101-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A205101-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A205101-002 | AB | 1 | 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 | Aphena Pharma Solutions - Tennessee, LLC | 7a2aa696-7dac-4d03-916a-374b61a255b5 | 2024-02-16 | Warnings, Adverse reactions | 205101 ANDA205101 |
| Gabapentin | GABAPENTIN | Aphena Pharma Solutions - Tennessee, LLC | 79cd9dea-e7d0-44db-afba-964cb99f32b6 | 2024-01-31 | Warnings, Adverse reactions | 205101 ANDA205101 |
| Gabapentin | GABAPENTIN | Aphena Pharma Solutions - Tennessee, LLC | f9bf87e4-5499-4dd7-a0c1-16025a718d14 | 2024-01-09 | Warnings, Adverse reactions | 205101 ANDA205101 |
| Gabapentin | GABAPENTIN | Proficient Rx LP | 9c96b488-19bd-431e-af9a-b313ffd9eaae | 2023-10-01 | Warnings, Adverse reactions | 205101 ANDA205101 |
| Gabapentin | GABAPENTIN | Aphena Pharma Solutions - Tennessee, LLC | af62bb7e-162e-4e2a-8eb0-d50f66678707 | 2023-09-22 | Warnings, Adverse reactions | 205101 ANDA205101 |
| Gabapentin | GABAPENTIN | Proficient Rx LP | 35004f84-90ae-45f0-a2ba-653dec507229 | 2023-03-01 | Warnings, Adverse reactions | 205101 ANDA205101 |
| Gabapentin | GABAPENTIN | Asclemed USA, Inc. | 9d544944-ea95-42e1-8c65-9e442437f0ee | 2022-10-10 | Warnings, Adverse reactions | 205101 ANDA205101 |
| Gabapentin | GABAPENTIN | Asclemed USA, Inc. | c18d9d06-f796-4eb7-8fd5-1de4ebb95439 | 2022-07-07 | Warnings, Adverse reactions | 205101 ANDA205101 |
| Gabapentin | GABAPENTIN | Proficient Rx LP | b67b7865-df64-429a-9550-5333b9c713ea | 2022-04-01 | Warnings, Adverse reactions | 205101 ANDA205101 |
| Gabapentin | GABAPENTIN | Proficient Rx LP | 2fb2233f-9152-4630-ab39-51a0cda7e5ca | 2022-04-01 | Warnings, Adverse reactions | 205101 ANDA205101 |
| Gabapentin | GABAPENTIN | Proficient Rx LP | 2b76955c-52a4-4026-b286-3da1112fe989 | 2022-04-01 | Warnings, Adverse reactions | 205101 ANDA205101 |
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 |
|---|---|---|---|---|---|
| 10135-647 | Gabapentin | Gabapentin | Marlex Pharmaceuticals Inc | ANDA | Current |
| 10135-647 | Gabapentin | Gabapentin | Marlex Pharmaceuticals Inc | ANDA | Current |
| 10135-648 | Gabapentin | Gabapentin | Marlex Pharmaceuticals Inc | ANDA | Current |
| 10135-648 | Gabapentin | Gabapentin | Marlex Pharmaceuticals Inc | ANDA | Current |
| 17856-0135 | Gabapentin | Gabapentin | Atlantic Biologicals Corps | ANDA | Current |
| 43063-756 | GABAPENTIN | GABAPENTIN | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-756 | GABAPENTIN | GABAPENTIN | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-756 | GABAPENTIN | GABAPENTIN | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-756 | GABAPENTIN | GABAPENTIN | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-756 | GABAPENTIN | GABAPENTIN | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-757 | GABAPENTIN | GABAPENTIN | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-757 | GABAPENTIN | GABAPENTIN | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-757 | GABAPENTIN | GABAPENTIN | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-757 | GABAPENTIN | GABAPENTIN | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-776 | GABAPENTIN | GABAPENTIN | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43547-389 | GABAPENTIN | GABAPENTIN | Solco Healthcare U.S., LLC | ANDA | Current |
| 43547-389 | GABAPENTIN | GABAPENTIN | Solco Healthcare U.S., LLC | ANDA | Current |
| 43547-389 | GABAPENTIN | GABAPENTIN | Solco Healthcare U.S., LLC | ANDA | Current |
| 43547-390 | GABAPENTIN | GABAPENTIN | Solco Healthcare U.S., LLC | ANDA | Current |
| 43547-390 | GABAPENTIN | GABAPENTIN | Solco Healthcare U.S., LLC | ANDA | Current |
| 43547-390 | GABAPENTIN | GABAPENTIN | Solco Healthcare U.S., LLC | ANDA | Current |
| 50090-4723 | GABAPENTIN | GABAPENTIN | A-S Medication Solutions | ANDA | Current |
| 50090-4723 | GABAPENTIN | GABAPENTIN | A-S Medication Solutions | ANDA | Current |
| 50090-5045 | Gabapentin | Gabapentin | A-S Medication Solutions | ANDA | Current |
| 50090-5045 | Gabapentin | Gabapentin | A-S Medication Solutions | ANDA | Current |
| 50228-177 | Gabapentin | Gabapentin | ScieGen Pharmaceuticals, Inc. | ANDA | Current |
| 50228-177 | Gabapentin | Gabapentin | ScieGen Pharmaceuticals, Inc. | ANDA | Current |
| 50228-177 | Gabapentin | Gabapentin | ScieGen Pharmaceuticals, Inc. | ANDA | Current |
| 50228-177 | Gabapentin | Gabapentin | ScieGen Pharmaceuticals, Inc. | ANDA | Current |
| 50228-177 | Gabapentin | Gabapentin | ScieGen Pharmaceuticals, Inc. | ANDA | Current |
| 50228-178 | Gabapentin | Gabapentin | ScieGen Pharmaceuticals, Inc. | ANDA | Current |
| 50228-178 | Gabapentin | Gabapentin | ScieGen Pharmaceuticals, Inc. | ANDA | Current |
| 50228-178 | Gabapentin | Gabapentin | ScieGen Pharmaceuticals, Inc. | ANDA | Current |
| 50228-178 | Gabapentin | Gabapentin | ScieGen Pharmaceuticals, Inc. | ANDA | Current |
| 50228-178 | Gabapentin | Gabapentin | ScieGen Pharmaceuticals, Inc. | ANDA | Current |
| 55700-686 | Gabapentin | Gabapentin | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-686 | Gabapentin | Gabapentin | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-686 | Gabapentin | Gabapentin | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 58657-623 | GABAPENTIN | GABAPENTIN | Method Pharmaceuticals, LLC | ANDA | Current |
| 58657-623 | GABAPENTIN | GABAPENTIN | Method Pharmaceuticals, LLC | ANDA | Current |
| 58657-624 | GABAPENTIN | GABAPENTIN | Method Pharmaceuticals, LLC | ANDA | Current |
| 58657-624 | GABAPENTIN | GABAPENTIN | Method Pharmaceuticals, LLC | ANDA | Current |
| 60760-517 | Gabapentin | Gabapentin | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 60760-743 | Gabapentin | Gabapentin | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 60760-743 | Gabapentin | Gabapentin | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 63629-8489 | Gabapentin | Gabapentin | Bryant Ranch Prepack | ANDA | Current |
| 63629-8489 | Gabapentin | Gabapentin | Bryant Ranch Prepack | ANDA | Current |
| 63629-8490 | Gabapentin | Gabapentin | Bryant Ranch Prepack | ANDA | Current |
| 63629-8490 | Gabapentin | Gabapentin | Bryant Ranch Prepack | ANDA | Current |
| 63629-8491 | Gabapentin | Gabapentin | Bryant Ranch Prepack | ANDA | Current |
| 63629-8491 | Gabapentin | Gabapentin | Bryant Ranch Prepack | ANDA | Current |
| 63629-8492 | Gabapentin | Gabapentin | Bryant Ranch Prepack | ANDA | Current |
| 63629-8492 | Gabapentin | Gabapentin | Bryant Ranch Prepack | ANDA | Current |
| 67296-1745 | GABAPENTIN | GABAPENTIN | RedPharm Drug, Inc. | ANDA | Current |
| 68071-2206 | Gabapentin | Gabapentin | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-2206 | Gabapentin | Gabapentin | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-2214 | Gabapentin | Gabapentin | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-2214 | Gabapentin | Gabapentin | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-2353 | GABAPENTIN | GABAPENTIN | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-2463 | Gabapentin | Gabapentin | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68788-7757 | Gabapentin | Gabapentin | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7757 | Gabapentin | Gabapentin | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7757 | Gabapentin | Gabapentin | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7774 | Gabapentin | Gabapentin | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7774 | Gabapentin | Gabapentin | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7774 | Gabapentin | Gabapentin | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7840 | Gabapentin | Gabapentin | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7840 | Gabapentin | Gabapentin | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7840 | Gabapentin | Gabapentin | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7847 | Gabapentin | Gabapentin | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7847 | Gabapentin | Gabapentin | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 69367-134 | Gabapentin | Gabapentin | Westminster Pharmaceuticals, LLC | ANDA | Current |
| 69367-134 | Gabapentin | Gabapentin | Westminster Pharmaceuticals, LLC | ANDA | Current |
| 69367-134 | Gabapentin | Gabapentin | Westminster Pharmaceuticals, LLC | ANDA | Current |
| 69367-134 | Gabapentin | Gabapentin | Westminster Pharmaceuticals, LLC | ANDA | Current |
| 69367-134 | Gabapentin | Gabapentin | Westminster Pharmaceuticals, LLC | ANDA | Current |
| 69367-134 | Gabapentin | Gabapentin | Westminster Pharmaceuticals, LLC | ANDA | Current |
| 69367-135 | Gabapentin | Gabapentin | Westminster Pharmaceuticals, LLC | ANDA | Current |
| 69367-135 | Gabapentin | Gabapentin | Westminster Pharmaceuticals, LLC | ANDA | Current |
| 69367-135 | Gabapentin | Gabapentin | Westminster Pharmaceuticals, LLC | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 32630 | ORIG | 2016-02-11 |