Application 021129
- Type
- NDA
- Sponsor
- PARKE DAVIS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | NEURONTIN | GABAPENTIN | SOLUTION;ORAL | 250MG/5ML | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N021129-001 | NEURONTIN | GABAPENTIN | 250MG/5ML | SOLUTION / ORAL | AA | RLD, RS | 2000-03-02 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N021129-001 | AA |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N021129-001 | NEURONTIN | 250MG/5ML | SOLUTION / ORAL | AA | RLD, RS | 2000-03-02 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021129-001 | NEURONTIN | 250MG/5ML | SOLUTION / ORAL | AA | RLD, RS | 2000-03-02 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N021129-001 | NEURONTIN | 250MG/5ML | SOLUTION / ORAL | AA | RLD, RS | 2000-03-02 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021129-001 | NEURONTIN | 250MG/5ML | SOLUTION / ORAL | AA | RLD, RS | 2000-03-02 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021129-001 | NEURONTIN | 250MG/5ML | SOLUTION / ORAL | AA | RLD, RS | 2000-03-02 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021129-001 | NEURONTIN | 250MG/5ML | SOLUTION / ORAL | AA | RLD, RS | 2000-03-02 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021129-001 | NEURONTIN | 250MG/5ML | SOLUTION / ORAL | AA | RLD, RS | 2000-03-02 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021129-001 | NEURONTIN | 250MG/5ML | SOLUTION / ORAL | AA | RLD, RS | 2000-03-02 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021129-001 | NEURONTIN | 250MG/5ML | SOLUTION / ORAL | AA | RLD, RS | 2000-03-02 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N021129-001 | NEURONTIN | 250MG/5ML | SOLUTION / ORAL | AA | RLD, RS | 2000-03-02 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021129-001 | NEURONTIN | 250MG/5ML | SOLUTION / ORAL | AA | RLD, RS | 2000-03-02 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021129-001 | NEURONTIN | 250MG/5ML | SOLUTION / ORAL | AA | RLD, RS | 2000-03-02 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021129-001 | NEURONTIN | 250MG/5ML | SOLUTION / ORAL | AA | RLD, RS | 2000-03-02 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N021129-001 | NEURONTIN | 250MG/5ML | SOLUTION / ORAL | AA | RLD, RS | 2000-03-02 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021129-001 | NEURONTIN | 250MG/5ML | SOLUTION / ORAL | AA | RLD, RS | 2000-03-02 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N021129-001 | NEURONTIN | 250MG/5ML | SOLUTION / ORAL | AA | RLD, RS | 2000-03-02 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N021129-001 | NEURONTIN | 250MG/5ML | SOLUTION / ORAL | AA | RLD, RS | 2000-03-02 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N021129-001 | NEURONTIN | 250MG/5ML | SOLUTION / ORAL | AA | RLD, RS | 2000-03-02 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N021129-001 | NEURONTIN | 250MG/5ML | SOLUTION / ORAL | AA | RLD, RS | 2000-03-02 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N021129-001 | NEURONTIN | 250MG/5ML | SOLUTION / ORAL | AA | RLD, RS | 2000-03-02 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021129-001 | NEURONTIN | 250MG/5ML | SOLUTION / ORAL | AA | RLD, RS | 2000-03-02 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N021129-001 | NEURONTIN | 250MG/5ML | SOLUTION / ORAL | AA | RLD, RS | 2000-03-02 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N021129-001 | NEURONTIN | 250MG/5ML | SOLUTION / ORAL | AA | RLD, RS | 2000-03-02 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N021129-001 | NEURONTIN | 250MG/5ML | SOLUTION / ORAL | AA | RLD, RS | 2000-03-02 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N021129-001 | NEURONTIN | 250MG/5ML | SOLUTION / ORAL | AA | RLD, RS | 2000-03-02 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N021129-001 | NEURONTIN | 250MG/5ML | SOLUTION / ORAL | AA | RLD, RS | 2000-03-02 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N021129-001 | NEURONTIN | 250MG/5ML | SOLUTION / ORAL | AA | RLD, RS | 2000-03-02 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N021129-001 | NEURONTIN | 250MG/5ML | SOLUTION / ORAL | AA | RLD, RS | 2000-03-02 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | N021129-001 | NEURONTIN | 250MG/5ML | SOLUTION / ORAL | AA | RLD, RS | 2000-03-02 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | N021129-001 | NEURONTIN | 250MG/5ML | SOLUTION / ORAL | AA | RLD, RS | 2000-03-02 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N021129-001 | NEURONTIN | 250MG/5ML | SOLUTION / ORAL | AA | RLD, RS | 2000-03-02 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N021129-001 | NEURONTIN | 250MG/5ML | SOLUTION / ORAL | AA | RLD, RS | 2000-03-02 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N021129-001 | NEURONTIN | 250MG/5ML | SOLUTION / ORAL | AA | RLD, RS | 2000-03-02 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N021129-001 | NEURONTIN | 250MG/5ML | SOLUTION / ORAL | AA | RLD, RS | 2000-03-02 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | N021129-001 | NEURONTIN | 250MG/5ML | SOLUTION / ORAL | AA | RLD, RS | 2000-03-02 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | N021129-001 | NEURONTIN | 250MG/5ML | SOLUTION / ORAL | AA | RLD, RS | 2000-03-02 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N021129-001 | NEURONTIN | 250MG/5ML | SOLUTION / ORAL | AA | RLD, RS | 2000-03-02 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | N021129-001 | NEURONTIN | 250MG/5ML | SOLUTION / ORAL | AA | RLD, RS | 2000-03-02 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | N021129-001 | NEURONTIN | 250MG/5ML | SOLUTION / ORAL | AA | RLD, RS | 2000-03-02 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N021129-001 | NEURONTIN | 250MG/5ML | SOLUTION / ORAL | AA | RLD, RS | 2000-03-02 | cb3db0bc1861… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N021129-001 | AA | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021129-001 | AA | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N021129-001 | AA | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021129-001 | AA | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021129-001 | AA | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021129-001 | AA | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021129-001 | AA | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021129-001 | AA | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021129-001 | AA | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N021129-001 | AA | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021129-001 | AA | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021129-001 | AA | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021129-001 | AA | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N021129-001 | AA | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021129-001 | AA | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N021129-001 | AA | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N021129-001 | AA | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N021129-001 | AA | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N021129-001 | AA | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N021129-001 | AA | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021129-001 | AA | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N021129-001 | AA | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N021129-001 | AA | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N021129-001 | AA | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N021129-001 | AA | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N021129-001 | AA | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N021129-001 | AA | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N021129-001 | AA | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | N021129-001 | AA | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | N021129-001 | AA | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N021129-001 | AA | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N021129-001 | AA | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N021129-001 | AA | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N021129-001 | AA | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | N021129-001 | AA | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | N021129-001 | AA | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N021129-001 | AA | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | N021129-001 | AA | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | N021129-001 | AA | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N021129-001 | AA | 1 | cb3db0bc1861… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021129-001 | 7256216 | 2022-05-28 | Drug product | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021129-001 | 7256216*PED | 2022-11-28 | Pediatric extension | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N021129-001 | 7256216 | 2022-05-28 | Drug product | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N021129-001 | 7256216*PED | 2022-11-28 | Pediatric extension | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N021129-001 | 7256216 | 2022-05-28 | Drug product | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N021129-001 | 7256216*PED | 2022-11-28 | Pediatric extension | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021129-001 | 7256216 | 2022-05-28 | Drug product | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021129-001 | 7256216*PED | 2022-11-28 | Pediatric extension | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | N021129-001 | 7256216 | 2022-05-28 | Drug product | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | N021129-001 | 7256216*PED | 2022-11-28 | Pediatric extension | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N021129-001 | 7256216 | 2022-05-28 | Drug product | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N021129-001 | 7256216*PED | 2022-11-28 | Pediatric extension | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021129-001 | 7256216 | 2022-05-28 | Drug product | 87673890dc5c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021129-001 | 7256216*PED | 2022-11-28 | Pediatric extension | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | N021129-001 | 7256216 | 2022-05-28 | Drug product | 5aa47cf7b7d7… | ||
| 2021-03-12 10:30 UTC | 2021-03 | N021129-001 | 7256216*PED | 2022-11-28 | Pediatric extension | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N021129-001 | 7256216 | 2022-05-28 | Drug product | 8869cabd3fbd… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N021129-001 | 7256216*PED | 2022-11-28 | Pediatric extension | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N021129-001 | 7256216 | 2022-05-28 | Drug product | c0c555d07b60… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N021129-001 | 7256216*PED | 2022-11-28 | Pediatric extension | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021129-001 | 7256216 | 2022-05-28 | Drug product | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021129-001 | 7256216*PED | 2022-11-28 | Pediatric extension | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N021129-001 | 7256216 | 2022-05-28 | Drug product | b00525d2431f… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N021129-001 | 7256216*PED | 2022-11-28 | Pediatric extension | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N021129-001 | 7256216 | 2022-05-28 | Drug product | ea99ee380514… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N021129-001 | 7256216*PED | 2022-11-28 | Pediatric extension | ea99ee380514… | ||
| 2023-01-26 05:58 UTC | 2023-01 | N021129-001 | 7256216 | 2022-05-28 | Drug product | 3bdfa0b2c4d7… | ||
| 2023-01-26 05:58 UTC | 2023-01 | N021129-001 | 7256216*PED | 2022-11-28 | Pediatric extension | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N021129-001 | 7256216 | 2022-05-28 | Drug product | 3a93d1ddd44b… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N021129-001 | 7256216*PED | 2022-11-28 | Pediatric extension | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | N021129-001 | 7256216 | 2022-05-28 | Drug product | f41ea6bd6efb… | ||
| 2022-10-28 04:53 UTC | 2022-10 | N021129-001 | 7256216*PED | 2022-11-28 | Pediatric extension | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | N021129-001 | 7256216 | 2022-05-28 | Drug product | e64feba35796… | ||
| 2022-09-29 23:25 UTC | 2022-09 | N021129-001 | 7256216*PED | 2022-11-28 | Pediatric extension | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N021129-001 | 7256216 | 2022-05-28 | Drug product | cb3db0bc1861… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N021129-001 | 7256216*PED | 2022-11-28 | Pediatric extension | cb3db0bc1861… |
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 |
|---|---|---|---|---|---|---|
| Neurontin | GABAPENTIN | Viatris Specialty LLC | 97935fd9-1d4a-43b6-a5d9-de994591187b | 2026-05-12 | Warnings, Adverse reactions | 021129 NDA021129 |
| GABAPENTIN | GABAPENTIN | Mylan Pharmaceuticals Inc. | cff7de45-148b-4e96-88fd-6052bf75b5f7 | 2025-04-12 | Warnings, Adverse reactions | 021129 NDA021129 59762-5050 |
| Neurontin | GABAPENTIN | Parke-Davis Div of Pfizer Inc | ee9ad9ed-6d9f-4ee1-9d7f-cfad438df388 | 2022-07-12 | Warnings, Adverse reactions | 021129 NDA021129 0071-2012 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0071-2012 | Neurontin | gabapentin | Parke-Davis Div of Pfizer Inc | NDA | Current |
| 0071-2012 | Neurontin | gabapentin | Parke-Davis Div of Pfizer Inc | NDA | Current |
| 0071-2012 | Neurontin | gabapentin | Parke-Davis Div of Pfizer | NDA | Current |
| 0071-2012 | Neurontin | gabapentin | Parke-Davis Div of Pfizer Inc | NDA | Current |
| 0071-2012 | Neurontin | gabapentin | Parke-Davis Div of Pfizer Inc | NDA | Current |
| 0071-2012 | Neurontin | gabapentin | Parke-Davis Div of Pfizer Inc | NDA | Current |
| 0071-2012 | Neurontin | gabapentin | Parke-Davis Div of Pfizer Inc | NDA | Current |
| 59762-5025 | GABAPENTIN | gabapentin | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-5025 | GABAPENTIN | gabapentin | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-5025 | GABAPENTIN | gabapentin | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-5025 | GABAPENTIN | gabapentin | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-5025 | GABAPENTIN | gabapentin | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-5025 | GABAPENTIN | gabapentin | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-5050 | GABAPENTIN | gabapentin | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-5050 | GABAPENTIN | gabapentin | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-5050 | GABAPENTIN | gabapentin | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
| 59762-5050 | GABAPENTIN | gabapentin | Greenstone LLC | NDA AUTHORIZED GENERIC | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 82120 | SUPPL | 2025-05-01 |
| 82070 | SUPPL | 2025-04-29 |
| 82069 | SUPPL | 2025-04-29 |
| 79111 | SUPPL | 2024-07-18 |
| 79097 | SUPPL | 2024-07-15 |
| 65668 | SUPPL | 2020-12-21 |
| 65667 | SUPPL | 2020-12-21 |
| 65636 | SUPPL | 2020-12-21 |
| 62534 | SUPPL | 2020-04-10 |
| 62434 | SUPPL | 2020-04-03 |
| 50124 | SUPPL | 2017-10-20 |
| 50103 | SUPPL | 2017-10-19 |
| 47752 | SUPPL | 2017-03-29 |
| 47715 | SUPPL | 2017-03-27 |
| 47714 | SUPPL | 2017-03-27 |
| 14451 | SUPPL | 2015-09-23 |
| 4402 | SUPPL | 2015-09-17 |
| 36169 | SUPPL | 2015-04-27 |
| 4403 | SUPPL | 2015-04-22 |
| 14450 | SUPPL | 2014-08-20 |
| 4401 | SUPPL | 2014-08-20 |
| 36168 | SUPPL | 2013-05-09 |
| 36167 | SUPPL | 2013-05-09 |
| 14449 | SUPPL | 2013-05-09 |
| 26842 | SUPPL | 2013-05-07 |
| 4400 | SUPPL | 2013-05-07 |
| 4399 | SUPPL | 2013-05-07 |
| 4398 | SUPPL | 2011-08-12 |
| 36166 | SUPPL | 2011-08-11 |
| 4397 | SUPPL | 2011-03-07 |
| 36165 | SUPPL | 2011-03-04 |
| 26841 | SUPPL | 2010-10-13 |
| 14448 | SUPPL | 2010-10-11 |
| 26840 | SUPPL | 2009-05-01 |
| 14447 | SUPPL | 2009-04-28 |
| 44100 | ORIG | 2008-02-01 |
| 4396 | SUPPL | 2006-05-05 |
| 26839 | SUPPL | 2005-02-23 |
| 14446 | SUPPL | 2005-02-23 |
| 4395 | SUPPL | 2004-06-10 |
| 41967 | SUPPL | 2004-05-06 |
| 21464 | ORIG | 2004-05-06 |
| 26838 | SUPPL | 2002-01-30 |