Application 090858
- Type
- ANDA
- Sponsor
- ALKEM
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 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A090858-001 | GABAPENTIN | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2010-12-17 | |
| A090858-002 | GABAPENTIN | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2010-12-17 | |
| A090858-003 | GABAPENTIN | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2010-12-17 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A090858-001 | AB |
| A090858-002 | AB |
| A090858-003 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A090858-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2010-12-17 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | A090858-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2010-12-17 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | A090858-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2010-12-17 | c2088c7a36db… | |
| 2026-09-14 22:38:34 | 2026-08 | A090858-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2010-12-17 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A090858-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2010-12-17 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A090858-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2010-12-17 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A090858-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2010-12-17 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A090858-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2010-12-17 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A090858-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2010-12-17 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A090858-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2010-12-17 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A090858-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2010-12-17 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A090858-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2010-12-17 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090858-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2010-12-17 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090858-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2010-12-17 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090858-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2010-12-17 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A090858-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2010-12-17 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A090858-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2010-12-17 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A090858-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2010-12-17 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090858-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2010-12-17 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090858-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2010-12-17 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090858-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2010-12-17 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090858-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2010-12-17 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090858-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2010-12-17 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090858-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2010-12-17 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090858-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2010-12-17 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090858-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2010-12-17 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090858-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2010-12-17 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090858-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2010-12-17 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090858-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2010-12-17 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090858-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2010-12-17 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090858-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2010-12-17 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090858-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2010-12-17 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090858-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2010-12-17 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090858-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2010-12-17 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090858-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2010-12-17 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090858-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2010-12-17 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A090858-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2010-12-17 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A090858-002 | GABAPENTIN | 300MG | CAPSULE / ORAL | AB | 2010-12-17 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A090858-003 | GABAPENTIN | 400MG | CAPSULE / ORAL | AB | 2010-12-17 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090858-001 | GABAPENTIN | 100MG | CAPSULE / ORAL | AB | 2010-12-17 | 79d66fd596c7… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A090858-001 | AB | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A090858-002 | AB | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A090858-003 | AB | 1 | c2088c7a36db… |
| 2026-09-14 22:38:34 | 2026-08 | A090858-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A090858-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A090858-003 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A090858-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A090858-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A090858-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A090858-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A090858-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A090858-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090858-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090858-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090858-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A090858-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A090858-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A090858-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090858-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090858-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090858-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090858-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090858-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090858-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090858-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090858-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090858-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090858-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090858-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090858-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090858-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090858-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090858-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090858-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090858-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090858-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A090858-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A090858-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A090858-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090858-001 | 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 | Advanced Rx of Tennessee, LLC | afc83432-8fce-6d2a-e053-2a95a90ae73f | 2026-03-19 | Warnings, Adverse reactions | 090858 ANDA090858 |
| Gabapentin | GABAPENTIN | A-S Medication Solutions | c979f80b-d4b1-40f7-b878-b216db5f325d | 2026-02-10 | Warnings, Adverse reactions | 090858 ANDA090858 |
| Gabapentin | GABAPENTIN | American Health Packaging | bbfdedd7-2baf-4bc6-be59-548a5cf21752 | 2025-10-03 | Warnings, Adverse reactions | 090858 ANDA090858 60687-580 60687-591 60687-602 |
| Gabapentin | GABAPENTIN | McKesson Corporation dba Sky Packaging | 23eb133e-2f74-4219-9892-0a8e770ec032 | 2025-04-17 | Warnings, Adverse reactions | 090858 ANDA090858 63739-904 63739-903 63739-902 |
| Gabapentin | GABAPENTIN | Clinical Solutions Wholesale, LLC | 743faa18-5e7c-4fcc-9781-4157450d90c4 | 2025-01-16 | Warnings, Adverse reactions | 090858 ANDA090858 |
| Gabapentin | GABAPENTIN | Advanced Rx Pharmacy of Tennessee, LLC | c89a68b6-6dc0-4624-e053-2a95a90a687e | 2024-12-31 | Warnings, Adverse reactions | 090858 ANDA090858 |
| Gabapentin | GABAPENTIN | NuCare Pharmaceuticals,Inc. | a072d5d2-8c75-59cc-e053-2a95a90ac0cc | 2024-11-05 | Warnings, Adverse reactions | 090858 ANDA090858 68071-5193 |
| Gabapentin | GABAPENTIN | A-S Medication Solutions | 77d1d90d-e124-4db7-b811-754d535e579c | 2023-09-10 | Warnings, Adverse reactions | 090858 ANDA090858 |
| Gabapentin | GABAPENTIN | Proficient Rx LP | 176c5b60-93c2-4574-8b51-c15180912aaa | 2022-08-01 | Warnings, Adverse reactions | 090858 ANDA090858 |
| Gabapentin | GABAPENTIN | Asclemed USA, Inc. | 14b1840d-a2db-4eec-bc25-029e35b042e4 | 2022-07-09 | Warnings, Adverse reactions | 090858 ANDA090858 |
| Gabapentin | GABAPENTIN | Proficient Rx LP | 2ef99c3d-866a-438b-a340-8beba8d4c457 | 2019-11-01 | Warnings, Adverse reactions | 090858 ANDA090858 63187-810 |
| Gabapentin | GABAPENTIN | Aphena Pharma Solutions - Tennessee, LLC | f455b415-12a2-4916-b826-246976a8af44 | 2018-09-12 | Warnings, Adverse reactions | 090858 ANDA090858 |
| Gabapentin | GABAPENTIN | Aphena Pharma Solutions - Tennessee, LLC | 6fc8e8b2-5d0e-4c72-9a46-6d312c3efac7 | 2018-05-14 | Warnings, Adverse reactions | 090858 ANDA090858 |
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 |
|---|---|---|---|---|---|
| 55700-544 | Gabapentin | Gabapentin | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-584 | Gabapentin | Gabapentin | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-584 | Gabapentin | Gabapentin | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-584 | Gabapentin | Gabapentin | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-584 | Gabapentin | Gabapentin | Quality Care Products LLC | ANDA | Current |
| 55700-812 | Gabapentin | Gabapentin | Quality Care Products, LLC | ANDA | Current |
| 55700-812 | Gabapentin | Gabapentin | Quality Care Products, LLC | ANDA | Current |
| 55700-812 | Gabapentin | Gabapentin | Quality Care Products, LLC | ANDA | Current |
| 55700-812 | Gabapentin | Gabapentin | Quality Care Products, LLC | ANDA | Current |
| 55700-812 | Gabapentin | Gabapentin | Quality Care Products, LLC | ANDA | Current |
| 60687-580 | Gabapentin | Gabapentin | American Health Packaging | ANDA | Current |
| 60687-580 | Gabapentin | Gabapentin | American Health Packaging | ANDA | Current |
| 60687-591 | Gabapentin | Gabapentin | American Health Packaging | ANDA | Current |
| 60687-591 | Gabapentin | Gabapentin | American Health Packaging | ANDA | Current |
| 60687-602 | Gabapentin | Gabapentin | American Health Packaging | ANDA | Current |
| 60687-602 | Gabapentin | Gabapentin | American Health Packaging | ANDA | Current |
| 60760-857 | Gabapentin | Gabapentin | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 63187-810 | Gabapentin | Gabapentin | Proficient Rx LP | ANDA | Current |
| 63187-810 | Gabapentin | Gabapentin | Proficient Rx LP | ANDA | Current |
| 63187-810 | Gabapentin | Gabapentin | Proficient Rx LP | ANDA | Current |
| 63739-902 | Gabapentin | Gabapentin | McKesson Corporation dba Sky Packaging | ANDA | Current |
| 63739-903 | Gabapentin | Gabapentin | McKesson Corporation dba Sky Packaging | ANDA | Current |
| 63739-904 | Gabapentin | Gabapentin | McKesson Corporation dba Sky Packaging | ANDA | Current |
| 67046-225 | Gabapentin | Gabapentin | Contract Pharmacy Services-PA | ANDA | Current |
| 67046-226 | Gabapentin | Gabapentin | Contract Pharmacy Services-PA | ANDA | Current |
| 67046-232 | Gabapentin | Gabapentin | Contract Pharmacy Services-PA | ANDA | Current |
| 67296-1142 | Gabapentin | Gabapentin | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1142 | Gabapentin | Gabapentin | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1142 | Gabapentin | Gabapentin | RedPharm Drug, Inc. | ANDA | Current |
| 67877-222 | Gabapentin | Gabapentin | Ascend Laboratories, LLC | ANDA | Current |
| 67877-222 | Gabapentin | Gabapentin | Ascend Laboratories, LLC | ANDA | Current |
| 67877-222 | Gabapentin | Gabapentin | Ascend Laboratories, LLC | ANDA | Current |
| 67877-222 | Gabapentin | Gabapentin | Ascend Laboratories, LLC | ANDA | Current |
| 67877-222 | Gabapentin | Gabapentin | Ascend Laboratories, LLC | ANDA | Current |
| 67877-222 | Gabapentin | Gabapentin | Ascend Laboratories, LLC | ANDA | Current |
| 67877-223 | Gabapentin | Gabapentin | Ascend Laboratories, LLC | ANDA | Current |
| 67877-223 | Gabapentin | Gabapentin | Ascend Laboratories, LLC | ANDA | Current |
| 67877-223 | Gabapentin | Gabapentin | Ascend Laboratories, LLC | ANDA | Current |
| 67877-223 | Gabapentin | Gabapentin | Ascend Laboratories, LLC | ANDA | Current |
| 67877-223 | Gabapentin | Gabapentin | Ascend Laboratories, LLC | ANDA | Current |
| 67877-223 | Gabapentin | Gabapentin | Ascend Laboratories, LLC | ANDA | Current |
| 67877-224 | Gabapentin | Gabapentin | Ascend Laboratories, LLC | ANDA | Current |
| 67877-224 | Gabapentin | Gabapentin | Ascend Laboratories, LLC | ANDA | Current |
| 67877-224 | Gabapentin | Gabapentin | Ascend Laboratories, LLC | ANDA | Current |
| 67877-224 | Gabapentin | Gabapentin | Ascend Laboratories, LLC | ANDA | Current |
| 67877-224 | Gabapentin | Gabapentin | Ascend Laboratories, LLC | ANDA | Current |
| 67877-224 | Gabapentin | Gabapentin | Ascend Laboratories, LLC | ANDA | Current |
| 68071-4729 | Gabapentin | Gabapentin | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4729 | Gabapentin | Gabapentin | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5193 | Gabapentin | Gabapentin | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5193 | Gabapentin | Gabapentin | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68788-7043 | Gabapentin | Gabapentin | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7043 | Gabapentin | Gabapentin | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7043 | Gabapentin | Gabapentin | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7043 | Gabapentin | Gabapentin | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7043 | Gabapentin | Gabapentin | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7044 | Gabapentin | Gabapentin | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7044 | Gabapentin | Gabapentin | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7044 | Gabapentin | Gabapentin | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7044 | Gabapentin | Gabapentin | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7044 | Gabapentin | Gabapentin | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7119 | Gabapentin | Gabapentin | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7119 | Gabapentin | Gabapentin | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7119 | Gabapentin | Gabapentin | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7777 | Gabapentin | Gabapentin | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7777 | Gabapentin | Gabapentin | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7777 | Gabapentin | Gabapentin | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-9509 | Gabapentin | Gabapentin | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-9509 | Gabapentin | Gabapentin | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-9509 | Gabapentin | Gabapentin | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-9509 | Gabapentin | Gabapentin | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-9509 | Gabapentin | Gabapentin | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 69176-100 | Cyclo/Gaba 10/300 Pack | Cyclo/Gaba 10/300 Pack | TMIG Inc. | ANDA | Current |
| 69176-200 | Gabapentin | Gabapentin | TMIG Inc. | ANDA | Current |
| 69189-0683 | Gabapentin | Gabapentin | Avera McKennan Hospital | ANDA | Current |
| 70518-0053 | Gabapentin | Gabapentin | REMEDYREPACK INC. | ANDA | Current |
| 70518-0053 | Gabapentin | Gabapentin | REMEDYREPACK INC. | ANDA | Current |
| 70518-0053 | Gabapentin | Gabapentin | REMEDYREPACK INC. | ANDA | Current |
| 70518-0053 | Gabapentin | Gabapentin | REMEDYREPACK INC. | ANDA | Current |
| 70518-0053 | Gabapentin | Gabapentin | REMEDYREPACK INC. | ANDA | Current |