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 | PD-Rx Pharmaceuticals, Inc. | 9b175f8d-7667-4bfe-8bb5-fd7441eed456 | 2026-07-08 | Warnings, Adverse reactions | 205101 ANDA205101 72789-217 |
| Gabapentin | GABAPENTIN | HAWAII REPACK, INC. | f6ff265b-569b-4f5c-8fdb-00b7ad4aac7c | 2026-07-02 | Warnings, Adverse reactions | 205101 ANDA205101 |
| Gabapentin | GABAPENTIN | St. Mary's Medical Park Pharmacy | ba4d863d-be38-8cf5-e053-2995a90a69fb | 2026-06-26 | Warnings, Adverse reactions | 205101 ANDA205101 |
| Gabapentin | GABAPENTIN | St. Mary's Medical Park Pharmacy | c85ae572-9893-629e-e053-2995a90a23fc | 2026-06-26 | Warnings, Adverse reactions | 205101 ANDA205101 |
| Gabapentin | GABAPENTIN | Bryant Ranch Prepack | ce0f0d7f-da6d-47da-a4ed-fb8f72902412 | 2026-04-13 | Warnings, Adverse reactions | 205101 ANDA205101 |
| Gabapentin | GABAPENTIN | Bryant Ranch Prepack | abb56036-88df-4720-ba78-529971671545 | 2026-04-13 | Warnings, Adverse reactions | 205101 ANDA205101 |
| Gabapentin | GABAPENTIN | Bryant Ranch Prepack | a75c9157-a1fc-44cc-89f8-c5a3742fb9ed | 2026-04-13 | Warnings, Adverse reactions | 205101 ANDA205101 |
| Gabapentin | GABAPENTIN | Bryant Ranch Prepack | d1aa4690-57b5-4a3e-ac12-85f777dbd05e | 2026-04-13 | Warnings, Adverse reactions | 205101 ANDA205101 |
| Gabapentin | GABAPENTIN | Bryant Ranch Prepack | 75caca13-1432-4c0d-8d45-f029b0b2d417 | 2026-03-31 | Warnings, Adverse reactions | 205101 ANDA205101 |
| Gabapentin | GABAPENTIN | Bryant Ranch Prepack | 56378630-e7a7-4981-8212-8ea703a433d8 | 2026-03-31 | Warnings, Adverse reactions | 205101 ANDA205101 |
| Gabapentin | GABAPENTIN | Radha Pharmaceuticals, Inc. | 1045db4e-4c76-4a0d-bf12-019bd96a8f59 | 2026-03-11 | Warnings, Adverse reactions | 205101 ANDA205101 |
| Gabapentin | GABAPENTIN | ScieGen Pharmaceuticals, Inc. | 5ab9c18b-9568-4dcb-90b0-252aef8f8dc2 | 2026-02-20 | Warnings, Adverse reactions | 205101 ANDA205101 |
| Gabapentin | GABAPENTIN | Preferred Pharmaceuticals, Inc. | 5d3f27bf-3486-40fa-a4d3-5f0b2c6c0151 | 2025-06-11 | Warnings, Adverse reactions | 205101 ANDA205101 |
| Gabapentin | GABAPENTIN | Preferred Pharmaceuticals, Inc. | 561f53d5-5301-42b3-b372-f3d49d642a2e | 2025-06-11 | Warnings, Adverse reactions | 205101 ANDA205101 |
| Gabapentin | GABAPENTIN | Coupler LLC | 3133fc78-dd7a-880c-e063-6394a90a89e1 | 2025-03-25 | Warnings, Adverse reactions | 205101 ANDA205101 |
| Gabapentin | GABAPENTIN | Directrx | d5c9dd2c-b8ee-1406-e053-2995a90a0287 | 2025-01-21 | Adverse reactions | 205101 ANDA205101 72189-313 |
| GABAPENTIN | GABAPENTIN | DIRECT RX | a7e45e3f-e382-32ba-e053-2a95a90a2537 | 2025-01-17 | 205101 ANDA205101 72189-178 | |
| Gabapentin | GABAPENTIN | Creekwood Pharmaceuticals LLC | 266ef369-0a56-f225-e063-6294a90a495e | 2024-09-01 | Warnings, Adverse reactions | 205101 ANDA205101 |
| Gabapentin | GABAPENTIN | NuCare Pharmaceuticals,Inc. | a9c99dfa-f54d-9207-e053-2995a90ad43b | 2024-07-17 | Warnings, Adverse reactions | 205101 ANDA205101 |
| Gabapentin | GABAPENTIN | NuCare Pharmaceuticals,Inc. | a9f0852e-0c58-ba22-e053-2995a90adfa0 | 2024-07-17 | 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 |
|---|---|---|---|---|---|
| 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 |
| 70518-2776 | Gabapentin | Gabapentin | REMEDYREPACK INC. | ANDA | Current |
| 70518-2776 | Gabapentin | Gabapentin | REMEDYREPACK INC. | ANDA | Current |
| 70518-2776 | Gabapentin | Gabapentin | REMEDYREPACK INC. | ANDA | Current |
| 71205-514 | Gabapentin | Gabapentin | Proficient Rx LP | ANDA | Current |
| 71205-514 | Gabapentin | Gabapentin | Proficient Rx LP | ANDA | Current |
| 71205-533 | Gabapentin | Gabapentin | Proficient Rx LP | ANDA | Current |
| 71205-533 | Gabapentin | Gabapentin | Proficient Rx LP | ANDA | Current |
| 71205-533 | Gabapentin | Gabapentin | Proficient Rx LP | ANDA | Current |
| 71205-931 | Gabapentin | Gabapentin | Proficient Rx LP | ANDA | Current |
| 71205-931 | Gabapentin | Gabapentin | Proficient Rx LP | ANDA | Current |
| 71205-931 | Gabapentin | Gabapentin | Proficient Rx LP | ANDA | Current |
| 71205-931 | Gabapentin | Gabapentin | Proficient Rx LP | ANDA | Current |
| 71205-932 | Gabapentin | Gabapentin | Proficient Rx LP | ANDA | Current |
| 71205-932 | Gabapentin | Gabapentin | Proficient Rx LP | ANDA | Current |
| 71205-932 | Gabapentin | Gabapentin | Proficient Rx LP | ANDA | Current |
| 71205-932 | Gabapentin | Gabapentin | Proficient Rx LP | ANDA | Current |
| 71399-0556 | Gabapentin | Gabapentin | Akron Pharma Inc | ANDA | Current |
| 71399-0558 | Gabapentin | Gabapentin | Akron Pharma Inc | ANDA | Current |
| 71610-400 | Gabapentin | Gabapentin | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 71610-400 | Gabapentin | Gabapentin | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 71610-400 | Gabapentin | Gabapentin | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 71610-400 | Gabapentin | Gabapentin | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 71610-410 | Gabapentin | Gabapentin | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 71610-432 | GABAPENTIN | GABAPENTIN | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 71610-437 | Gabapentin | Gabapentin | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 71610-442 | Gabapentin | Gabapentin | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 71610-442 | Gabapentin | Gabapentin | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 71610-442 | Gabapentin | Gabapentin | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 71610-442 | Gabapentin | Gabapentin | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 71610-463 | Gabapentin | Gabapentin | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 71610-463 | Gabapentin | Gabapentin | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 72189-178 | GABAPENTIN | GABAPENTIN | DIRECT RX | ANDA | Current |
| 72189-178 | GABAPENTIN | GABAPENTIN | DIRECT RX | ANDA | Current |
| 72189-178 | GABAPENTIN | GABAPENTIN | DIRECT RX | ANDA | Current |
| 72189-178 | GABAPENTIN | GABAPENTIN | DIRECT RX | ANDA | Current |
| 72189-178 | GABAPENTIN | GABAPENTIN | DIRECT RX | ANDA | Current |
| 72189-313 | Gabapentin | Gabapentin | Directrx | ANDA | Current |
| 72189-313 | Gabapentin | Gabapentin | Directrx | ANDA | Current |
| 72789-217 | Gabapentin | Gabapentin | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-217 | Gabapentin | Gabapentin | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 76420-235 | Gabapentin | Gabapentin | Asclemed USA, Inc. | ANDA | Current |
| 76420-497 | Gabapentin | Gabapentin | Asclemed USA, Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 32630 | ORIG | 2016-02-11 |