Application 214957
- Type
- ANDA
- Sponsor
- ASCENT 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 |
|---|---|---|---|---|---|---|---|
| A214957-001 | GABAPENTIN | GABAPENTIN | 600MG | TABLET / ORAL | AB1 | 2021-10-01 | |
| A214957-002 | GABAPENTIN | GABAPENTIN | 800MG | TABLET / ORAL | AB1 | 2021-10-01 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A214957-001 | AB1 |
| A214957-002 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A214957-001 | GABAPENTIN | 600MG | TABLET / ORAL | AB1 | 2021-10-01 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A214957-002 | GABAPENTIN | 800MG | TABLET / ORAL | AB1 | 2021-10-01 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A214957-001 | GABAPENTIN | 600MG | TABLET / ORAL | AB1 | 2021-10-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A214957-002 | GABAPENTIN | 800MG | TABLET / ORAL | AB1 | 2021-10-01 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A214957-001 | GABAPENTIN | 600MG | TABLET / ORAL | AB1 | 2021-10-01 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A214957-002 | GABAPENTIN | 800MG | TABLET / ORAL | AB1 | 2021-10-01 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A214957-001 | GABAPENTIN | 600MG | TABLET / ORAL | AB1 | 2021-10-01 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A214957-002 | GABAPENTIN | 800MG | TABLET / ORAL | AB1 | 2021-10-01 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A214957-001 | GABAPENTIN | 600MG | TABLET / ORAL | AB1 | 2021-10-01 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A214957-002 | GABAPENTIN | 800MG | TABLET / ORAL | AB1 | 2021-10-01 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A214957-001 | GABAPENTIN | 600MG | TABLET / ORAL | AB1 | 2021-10-01 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A214957-002 | GABAPENTIN | 800MG | TABLET / ORAL | AB1 | 2021-10-01 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A214957-001 | GABAPENTIN | 600MG | TABLET / ORAL | AB1 | 2021-10-01 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A214957-002 | GABAPENTIN | 800MG | TABLET / ORAL | AB1 | 2021-10-01 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A214957-001 | GABAPENTIN | 600MG | TABLET / ORAL | AB1 | 2021-10-01 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A214957-002 | GABAPENTIN | 800MG | TABLET / ORAL | AB1 | 2021-10-01 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A214957-001 | GABAPENTIN | 600MG | TABLET / ORAL | AB1 | 2021-10-01 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A214957-002 | GABAPENTIN | 800MG | TABLET / ORAL | AB1 | 2021-10-01 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A214957-001 | GABAPENTIN | 600MG | TABLET / ORAL | AB1 | 2021-10-01 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A214957-002 | GABAPENTIN | 800MG | TABLET / ORAL | AB1 | 2021-10-01 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A214957-001 | GABAPENTIN | 600MG | TABLET / ORAL | AB1 | 2021-10-01 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A214957-002 | GABAPENTIN | 800MG | TABLET / ORAL | AB1 | 2021-10-01 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A214957-001 | GABAPENTIN | 600MG | TABLET / ORAL | AB1 | 2021-10-01 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A214957-002 | GABAPENTIN | 800MG | TABLET / ORAL | AB1 | 2021-10-01 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A214957-001 | GABAPENTIN | 600MG | TABLET / ORAL | AB1 | 2021-10-01 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A214957-002 | GABAPENTIN | 800MG | TABLET / ORAL | AB1 | 2021-10-01 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A214957-001 | GABAPENTIN | 600MG | TABLET / ORAL | AB1 | 2021-10-01 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A214957-002 | GABAPENTIN | 800MG | TABLET / ORAL | AB1 | 2021-10-01 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A214957-001 | GABAPENTIN | 600MG | TABLET / ORAL | AB1 | 2021-10-01 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A214957-002 | GABAPENTIN | 800MG | TABLET / ORAL | AB1 | 2021-10-01 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A214957-001 | GABAPENTIN | 600MG | TABLET / ORAL | AB | 2021-10-01 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A214957-002 | GABAPENTIN | 800MG | TABLET / ORAL | AB | 2021-10-01 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A214957-001 | GABAPENTIN | 600MG | TABLET / ORAL | AB | 2021-10-01 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A214957-002 | GABAPENTIN | 800MG | TABLET / ORAL | AB | 2021-10-01 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A214957-001 | GABAPENTIN | 600MG | TABLET / ORAL | AB | 2021-10-01 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A214957-002 | GABAPENTIN | 800MG | TABLET / ORAL | AB | 2021-10-01 | 4b0b4de00fa7… | |
| 2022-03-09 01:35 UTC | 2022-03 | A214957-001 | GABAPENTIN | 600MG | TABLET / ORAL | AB | 2021-10-01 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A214957-002 | GABAPENTIN | 800MG | TABLET / ORAL | AB | 2021-10-01 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A214957-001 | GABAPENTIN | 600MG | TABLET / ORAL | AB | 2021-10-01 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | A214957-002 | GABAPENTIN | 800MG | TABLET / ORAL | AB | 2021-10-01 | 782e0a99824c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A214957-001 | AB1 | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A214957-002 | AB1 | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A214957-001 | AB1 | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A214957-002 | AB1 | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A214957-001 | AB1 | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A214957-002 | AB1 | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A214957-001 | AB1 | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A214957-002 | AB1 | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A214957-001 | AB1 | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A214957-002 | AB1 | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A214957-001 | AB1 | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A214957-002 | AB1 | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A214957-001 | AB1 | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A214957-002 | AB1 | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A214957-001 | AB1 | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A214957-002 | AB1 | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A214957-001 | AB1 | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A214957-002 | AB1 | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A214957-001 | AB1 | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A214957-002 | AB1 | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A214957-001 | AB1 | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A214957-002 | AB1 | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A214957-001 | AB1 | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A214957-002 | AB1 | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A214957-001 | AB1 | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A214957-002 | AB1 | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A214957-001 | AB1 | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A214957-002 | AB1 | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A214957-001 | AB1 | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A214957-002 | AB1 | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A214957-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A214957-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A214957-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A214957-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A214957-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A214957-002 | AB | 1 | 4b0b4de00fa7… |
| 2022-03-09 01:35 UTC | 2022-03 | A214957-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A214957-002 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A214957-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A214957-002 | AB | 1 | 782e0a99824c… |
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 | Bryant Ranch Prepack | c9f0cceb-b24e-4526-b873-fedd877d6bc6 | 2026-06-18 | Warnings, Adverse reactions | 214957 ANDA214957 |
| GABAPENTIN | GABAPENTIN | St. Mary's Medical Park Pharmacy | 07f07d15-ee91-8c2a-e063-6394a90a4624 | 2026-06-03 | Warnings, Adverse reactions | 214957 ANDA214957 |
| GABAPENTIN | GABAPENTIN | Preferred Pharmaceuticals Inc. | 180b99a5-7d3d-4ee5-a0cc-1ae0ede646ee | 2026-05-04 | Warnings, Adverse reactions | 214957 ANDA214957 |
| GABAPENTIN | GABAPENTIN | Preferred Pharmaceuticals Inc. | 35da078b-0da0-4757-a6c4-a9144c37e8e1 | 2026-05-01 | Warnings, Adverse reactions | 214957 ANDA214957 |
| GABAPENTIN | GABAPENTIN | Preferred Pharmaceuticals Inc. | 38119f2e-33b3-4c3c-99b7-9335d8d280d4 | 2026-05-01 | Warnings, Adverse reactions | 214957 ANDA214957 |
| GABAPENTIN | GABAPENTIN | Coupler LLC | 500ee820-0378-6fc9-e063-6394a90a109c | 2026-04-24 | Warnings, Adverse reactions | 214957 ANDA214957 |
| GABAPENTIN | GABAPENTIN | ST. MARY'S MEDICAL PARK PHARMACY | 4ddc1342-5c83-f562-e063-6294a90a29ba | 2026-03-25 | Warnings, Adverse reactions | 214957 ANDA214957 |
| GABAPENTIN | GABAPENTIN | Bryant Ranch Prepack | 2e331641-ec26-4d76-b16b-a9863c767afe | 2026-02-06 | Warnings, Adverse reactions | 214957 ANDA214957 |
| GABAPENTIN | GABAPENTIN | Preferred Pharmaceuticals Inc. | 60b46f6d-efbc-487a-b672-b20df8b44cc4 | 2026-01-23 | Warnings, Adverse reactions | 214957 ANDA214957 |
| GABAPENTIN | GABAPENTIN | Proficient Rx LP | da8438e1-755b-4195-baa7-464f3d9ee5bd | 2025-10-01 | Warnings, Adverse reactions | 214957 ANDA214957 |
| GABAPENTIN | GABAPENTIN | Camber Pharmaceuticals, Inc. | 9ead7825-d11b-4e00-8533-328d097b8f83 | 2025-08-16 | Warnings, Adverse reactions | 214957 ANDA214957 31722-167 31722-166 |
| GABAPENTIN | GABAPENTIN | Exelan Pharmaceuticals, Inc. | a88edb00-2189-4c8d-9dd7-9fe1571775cc | 2025-08-16 | Warnings, Adverse reactions | 214957 ANDA214957 76282-707 76282-706 |
| GABAPENTIN | GABAPENTIN | XLCare Pharmaceuticals, Inc. | 707ed63a-67ca-4a62-9cbe-cdeb5c4ab506 | 2025-08-16 | Warnings, Adverse reactions | 214957 ANDA214957 |
| Gabapentin | GABAPENTIN | Direct_Rx | ed9c501c-24e4-da89-e053-2a95a90a64c6 | 2025-06-09 | Warnings, Adverse reactions | 214957 ANDA214957 72189-394 |
| GABAPENTIN | GABAPENTIN | Asclemed USA, Inc. | 1f1203f4-2184-4e13-e063-6394a90a4330 | 2025-05-21 | Warnings, Adverse reactions | 214957 ANDA214957 |
| GABAPENTIN | GABAPENTIN | Proficient Rx LP | 7fcce531-bf7c-43b6-bea9-8f0602842c53 | 2025-04-01 | Warnings, Adverse reactions | 214957 ANDA214957 |
| GABAPENTIN | GABAPENTIN | Coupler LLC | 3133c863-d33b-c9d7-e063-6294a90ae898 | 2025-03-25 | Warnings, Adverse reactions | 214957 ANDA214957 |
| GABAPENTIN | GABAPENTIN | NuCare Pharmaceuticals,Inc. | febf610e-e088-4797-e053-6294a90a3eb5 | 2025-02-04 | Warnings, Adverse reactions | 214957 ANDA214957 |
| Gabapentin | GABAPENTIN | Direct_Rx | fbc05ceb-2e69-3c37-e053-6394a90ac4f4 | 2024-09-06 | Warnings, Adverse reactions | 214957 ANDA214957 |
| GABAPENTIN | GABAPENTIN | Clinical Solutions Wholesale, LLC | 934fefae-b895-427c-8798-4c5462b1ecc2 | 2024-04-11 | Warnings, Adverse reactions | 214957 ANDA214957 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 31722-166 | GABAPENTIN | Gabapentin | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 31722-167 | GABAPENTIN | Gabapentin | Camber Pharmaceuticals, Inc. | ANDA | Current |
| 43602-466 | GABAPENTIN | Gabapentin | Ascent Pharmaceuticals, Inc | ANDA | Current |
| 43602-467 | GABAPENTIN | Gabapentin | Ascent Pharmaceuticals, Inc | ANDA | Current |
| 50090-6189 | GABAPENTIN | Gabapentin | A-S Medication Solutions | ANDA | Current |
| 71610-621 | GABAPENTIN | Gabapentin | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 71610-621 | GABAPENTIN | Gabapentin | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 71610-630 | GABAPENTIN | Gabapentin | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 71610-630 | GABAPENTIN | Gabapentin | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 72189-394 | Gabapentin | Gabapentin | Direct_Rx | ANDA | Current |
| 72189-394 | Gabapentin | Gabapentin | Direct_Rx | ANDA | Current |
| 76282-706 | GABAPENTIN | Gabapentin | Exelan Pharmaceuticals, Inc. | ANDA | Current |
| 76282-706 | GABAPENTIN | Gabapentin | Exelan Pharmaceuticals, Inc. | ANDA | Current |
| 76282-707 | GABAPENTIN | Gabapentin | Exelan Pharmaceuticals, Inc. | ANDA | Current |
| 76282-707 | GABAPENTIN | Gabapentin | Exelan Pharmaceuticals, Inc. | ANDA | Current |