Application 078327
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | SUMATRIPTAN SUCCINATE | SUMATRIPTAN SUCCINATE | TABLET;ORAL | EQ 25MG BASE | No | No |
| 002 | SUMATRIPTAN SUCCINATE | SUMATRIPTAN SUCCINATE | TABLET;ORAL | EQ 50MG BASE | No | No |
| 003 | SUMATRIPTAN SUCCINATE | SUMATRIPTAN SUCCINATE | TABLET;ORAL | EQ 100MG BASE | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A078327-001 | SUMATRIPTAN SUCCINATE | SUMATRIPTAN SUCCINATE | EQ 25MG BASE | TABLET / ORAL | AB | 2009-08-10 | |
| A078327-002 | SUMATRIPTAN SUCCINATE | SUMATRIPTAN SUCCINATE | EQ 50MG BASE | TABLET / ORAL | AB | 2009-08-10 | |
| A078327-003 | SUMATRIPTAN SUCCINATE | SUMATRIPTAN SUCCINATE | EQ 100MG BASE | TABLET / ORAL | AB | 2009-08-10 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A078327-001 | AB |
| A078327-002 | AB |
| A078327-003 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A078327-001 | SUMATRIPTAN SUCCINATE | EQ 25MG BASE | TABLET / ORAL | AB | 2009-08-10 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078327-002 | SUMATRIPTAN SUCCINATE | EQ 50MG BASE | TABLET / ORAL | AB | 2009-08-10 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078327-003 | SUMATRIPTAN SUCCINATE | EQ 100MG BASE | TABLET / ORAL | AB | 2009-08-10 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078327-001 | SUMATRIPTAN SUCCINATE | EQ 25MG BASE | TABLET / ORAL | AB | 2009-08-10 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078327-002 | SUMATRIPTAN SUCCINATE | EQ 50MG BASE | TABLET / ORAL | AB | 2009-08-10 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078327-003 | SUMATRIPTAN SUCCINATE | EQ 100MG BASE | TABLET / ORAL | AB | 2009-08-10 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078327-001 | SUMATRIPTAN SUCCINATE | EQ 25MG BASE | TABLET / ORAL | AB | 2009-08-10 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078327-002 | SUMATRIPTAN SUCCINATE | EQ 50MG BASE | TABLET / ORAL | AB | 2009-08-10 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078327-003 | SUMATRIPTAN SUCCINATE | EQ 100MG BASE | TABLET / ORAL | AB | 2009-08-10 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078327-001 | SUMATRIPTAN SUCCINATE | EQ 25MG BASE | TABLET / ORAL | AB | 2009-08-10 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078327-002 | SUMATRIPTAN SUCCINATE | EQ 50MG BASE | TABLET / ORAL | AB | 2009-08-10 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078327-003 | SUMATRIPTAN SUCCINATE | EQ 100MG BASE | TABLET / ORAL | AB | 2009-08-10 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078327-001 | SUMATRIPTAN SUCCINATE | EQ 25MG BASE | TABLET / ORAL | AB | 2009-08-10 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078327-002 | SUMATRIPTAN SUCCINATE | EQ 50MG BASE | TABLET / ORAL | AB | 2009-08-10 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078327-003 | SUMATRIPTAN SUCCINATE | EQ 100MG BASE | TABLET / ORAL | AB | 2009-08-10 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078327-001 | SUMATRIPTAN SUCCINATE | EQ 25MG BASE | TABLET / ORAL | AB | 2009-08-10 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078327-002 | SUMATRIPTAN SUCCINATE | EQ 50MG BASE | TABLET / ORAL | AB | 2009-08-10 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078327-003 | SUMATRIPTAN SUCCINATE | EQ 100MG BASE | TABLET / ORAL | AB | 2009-08-10 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078327-001 | SUMATRIPTAN SUCCINATE | EQ 25MG BASE | TABLET / ORAL | AB | 2009-08-10 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078327-002 | SUMATRIPTAN SUCCINATE | EQ 50MG BASE | TABLET / ORAL | AB | 2009-08-10 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078327-003 | SUMATRIPTAN SUCCINATE | EQ 100MG BASE | TABLET / ORAL | AB | 2009-08-10 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078327-001 | SUMATRIPTAN SUCCINATE | EQ 25MG BASE | TABLET / ORAL | AB | 2009-08-10 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078327-002 | SUMATRIPTAN SUCCINATE | EQ 50MG BASE | TABLET / ORAL | AB | 2009-08-10 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078327-003 | SUMATRIPTAN SUCCINATE | EQ 100MG BASE | TABLET / ORAL | AB | 2009-08-10 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078327-001 | SUMATRIPTAN SUCCINATE | EQ 25MG BASE | TABLET / ORAL | AB | 2009-08-10 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078327-002 | SUMATRIPTAN SUCCINATE | EQ 50MG BASE | TABLET / ORAL | AB | 2009-08-10 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078327-003 | SUMATRIPTAN SUCCINATE | EQ 100MG BASE | TABLET / ORAL | AB | 2009-08-10 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078327-001 | SUMATRIPTAN SUCCINATE | EQ 25MG BASE | TABLET / ORAL | AB | 2009-08-10 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078327-002 | SUMATRIPTAN SUCCINATE | EQ 50MG BASE | TABLET / ORAL | AB | 2009-08-10 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078327-003 | SUMATRIPTAN SUCCINATE | EQ 100MG BASE | TABLET / ORAL | AB | 2009-08-10 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078327-001 | SUMATRIPTAN SUCCINATE | EQ 25MG BASE | TABLET / ORAL | AB | 2009-08-10 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078327-002 | SUMATRIPTAN SUCCINATE | EQ 50MG BASE | TABLET / ORAL | AB | 2009-08-10 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078327-003 | SUMATRIPTAN SUCCINATE | EQ 100MG BASE | TABLET / ORAL | AB | 2009-08-10 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078327-001 | SUMATRIPTAN SUCCINATE | EQ 25MG BASE | TABLET / ORAL | AB | 2009-08-10 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078327-002 | SUMATRIPTAN SUCCINATE | EQ 50MG BASE | TABLET / ORAL | AB | 2009-08-10 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078327-003 | SUMATRIPTAN SUCCINATE | EQ 100MG BASE | TABLET / ORAL | AB | 2009-08-10 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078327-001 | SUMATRIPTAN SUCCINATE | EQ 25MG BASE | TABLET / ORAL | AB | 2009-08-10 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078327-002 | SUMATRIPTAN SUCCINATE | EQ 50MG BASE | TABLET / ORAL | AB | 2009-08-10 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078327-003 | SUMATRIPTAN SUCCINATE | EQ 100MG BASE | TABLET / ORAL | AB | 2009-08-10 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A078327-001 | SUMATRIPTAN SUCCINATE | EQ 25MG BASE | TABLET / ORAL | AB | 2009-08-10 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A078327-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078327-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078327-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078327-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078327-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078327-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A078327-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078327-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078327-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078327-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078327-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078327-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078327-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078327-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078327-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078327-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078327-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078327-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078327-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078327-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078327-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078327-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078327-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078327-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078327-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078327-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078327-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A078327-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078327-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078327-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078327-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078327-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078327-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078327-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078327-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078327-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078327-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078327-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078327-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A078327-001 | AB | 1 | 8072bd15b7f6… |
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 |
|---|---|---|---|---|---|---|
| Sumatriptan | SUMATRIPTAN SUCCINATE | REMEDYREPACK INC. | 73c9ac06-b55e-41e0-90ec-deb250f37eb5 | 2026-05-19 | Warnings, Adverse reactions | 078327 ANDA078327 |
| Sumatriptan | SUMATRIPTAN SUCCINATE | Aurobindo Pharma Limited | b2503fff-c978-4efa-b1b4-d7740b6b26f2 | 2026-05-12 | Warnings, Adverse reactions | 078327 ANDA078327 65862-146 65862-148 65862-147 |
| Sumatriptan | SUMATRIPTAN SUCCINATE | Sportpharm LLC | d071aef6-a5bd-4f68-ba6d-03004466897c | 2026-04-24 | Warnings, Adverse reactions | 078327 ANDA078327 |
| Sumatriptan | SUMATRIPTAN SUCCINATE | A-S Medication Solutions | 62ba6fef-467a-4500-993c-51907f12a67c | 2026-02-14 | Warnings, Adverse reactions | 078327 ANDA078327 50090-2144 50090-1129 50090-1130 |
| Sumatriptan | SUMATRIPTAN SUCCINATE | NorthStar Rx LLC | 84bfc4ba-4172-4adb-b963-4e0eb438c07a | 2026-02-13 | Warnings, Adverse reactions | 078327 ANDA078327 16714-797 16714-796 16714-798 |
| Sumatriptan | SUMATRIPTAN SUCCINATE | Preferred Pharmaceuticals, Inc. | f2e7d756-1e12-462a-a43f-a9d860b11ee8 | 2025-09-25 | Warnings, Adverse reactions | 078327 ANDA078327 |
| Sumatriptan | SUMATRIPTAN SUCCINATE | Preferred Pharmaceuticals, Inc. | bf9fd9fe-095b-4478-bd2e-a5534af07761 | 2025-09-25 | Warnings, Adverse reactions | 078327 ANDA078327 |
| Sumatriptan | SUMATRIPTAN SUCCINATE | Preferred Pharmaceuticals Inc. | baf37e8c-d414-4ca7-a366-97dc202372ff | 2025-09-25 | Warnings, Adverse reactions | 078327 ANDA078327 |
| Sumatriptan | SUMATRIPTAN SUCCINATE | NuCare Pharmaceuticals, Inc. | 2efd4269-5657-9669-e063-6394a90a583a | 2025-02-25 | Warnings, Adverse reactions | 078327 ANDA078327 |
| Sumatriptan | SUMATRIPTAN SUCCINATE | NuCare Pharmaceuticals, Inc. | 2a96f37d-03f6-678c-e063-6394a90ae0c6 | 2024-12-31 | Warnings, Adverse reactions | 078327 ANDA078327 |
| Sumatriptan | SUMATRIPTAN | Advanced Rx of Tennessee, LLC | f1a118cf-2179-572a-e053-2995a90acbb0 | 2024-12-31 | Warnings, Adverse reactions | 078327 ANDA078327 |
| Sumatriptan | SUMATRIPTAN SUCCINATE | Quality Care Products, LLC | 5d1f3de0-684a-4092-be30-aa325ff20d04 | 2024-12-18 | Warnings, Adverse reactions | 078327 ANDA078327 55700-899 |
| Sumatriptan | SUMATRIPTAN SUCCINATE | Quality Care Products, LLC | da77dfc4-551c-4e0e-a65e-cb478f193cd9 | 2024-12-18 | Warnings, Adverse reactions | 078327 ANDA078327 55700-936 |
| Sumatriptan | SUMATRIPTAN | Advanced Rx Pharmacy of Tennessee, LLC | f8c4bbfb-1586-4610-e053-6394a90a8f09 | 2024-08-27 | Warnings, Adverse reactions | 078327 ANDA078327 |
| Sumatriptan | SUMATRIPTAN SUCCINATE | NuCare Pharmaceuticals,Inc. | 54c6f8f4-5466-3988-e054-00144ff8d46c | 2024-07-10 | Warnings, Adverse reactions | 078327 ANDA078327 68071-3350 |
| Sumatriptan | SUMATRIPTAN SUCCINATE | NuCare Pharmaceuticals,Inc. | 933f6575-a4c4-0f65-e053-2a95a90ab967 | 2024-06-19 | 078327 ANDA078327 68071-5072 | |
| Sumatriptan | SUMATRIPTAN SUCCINATE | NuCare Pharmaceuticals,Inc. | 85295be9-852d-4e21-e053-2991aa0a8a78 | 2024-06-14 | Warnings, Adverse reactions | 078327 ANDA078327 68071-4815 |
| Sumatriptan | SUMATRIPTAN SUCCINATE | Proficient Rx LP | fe09fab6-b9e3-469c-9a38-bcc343dcc899 | 2023-01-01 | Warnings, Adverse reactions | 078327 ANDA078327 63187-931 |
| Sumatriptan | SUMATRIPTAN SUCCINATE | Asclemed USA, Inc. | 77f9f135-e840-48f0-81e8-73e08433e768 | 2022-10-11 | Warnings, Adverse reactions | 078327 ANDA078327 |
| Sumatriptan | SUMATRIPTAN SUCCINATE | Proficient Rx LP | abbd2168-1523-4eb6-a75c-dc4d7d1b1c9b | 2022-06-01 | Warnings, Adverse reactions | 078327 ANDA078327 63187-969 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 16714-796 | Sumatriptan | Sumatriptan Succinate | NorthStar Rx LLC | ANDA | Current |
| 16714-796 | Sumatriptan | Sumatriptan Succinate | NorthStar Rx LLC | ANDA | Current |
| 16714-796 | Sumatriptan | Sumatriptan Succinate | NorthStar Rx LLC | ANDA | Current |
| 16714-797 | Sumatriptan | Sumatriptan Succinate | NorthStar Rx LLC | ANDA | Current |
| 16714-797 | Sumatriptan | Sumatriptan Succinate | NorthStar Rx LLC | ANDA | Current |
| 16714-797 | Sumatriptan | Sumatriptan Succinate | NorthStar Rx LLC | ANDA | Current |
| 16714-798 | Sumatriptan | Sumatriptan Succinate | NorthStar Rx LLC | ANDA | Current |
| 16714-798 | Sumatriptan | Sumatriptan Succinate | NorthStar Rx LLC | ANDA | Current |
| 16714-798 | Sumatriptan | Sumatriptan Succinate | NorthStar Rx LLC | ANDA | Current |
| 33261-663 | Sumatriptan | Sumatriptan Succinate | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 50090-1129 | Sumatriptan | Sumatriptan Succinate | A-S Medication Solutions | ANDA | Current |
| 50090-1129 | Sumatriptan | Sumatriptan Succinate | A-S Medication Solutions | ANDA | Current |
| 50090-1129 | Sumatriptan | Sumatriptan Succinate | A-S Medication Solutions | ANDA | Current |
| 50090-1129 | Sumatriptan | Sumatriptan Succinate | A-S Medication Solutions | ANDA | Current |
| 50090-1129 | Sumatriptan | Sumatriptan Succinate | A-S Medication Solutions | ANDA | Current |
| 50090-1129 | Sumatriptan | Sumatriptan Succinate | A-S Medication Solutions | ANDA | Current |
| 50090-1130 | Sumatriptan | Sumatriptan Succinate | A-S Medication Solutions | ANDA | Current |
| 50090-1130 | Sumatriptan | Sumatriptan Succinate | A-S Medication Solutions | ANDA | Current |
| 50090-1130 | Sumatriptan | Sumatriptan Succinate | A-S Medication Solutions | ANDA | Current |
| 50090-1130 | Sumatriptan | Sumatriptan Succinate | A-S Medication Solutions | ANDA | Current |
| 50090-1130 | Sumatriptan | Sumatriptan Succinate | A-S Medication Solutions | ANDA | Current |
| 50090-1130 | Sumatriptan | Sumatriptan Succinate | A-S Medication Solutions | ANDA | Current |
| 50090-1130 | Sumatriptan | Sumatriptan Succinate | A-S Medication Solutions | ANDA | Current |
| 50090-2144 | Sumatriptan | Sumatriptan Succinate | A-S Medication Solutions | ANDA | Current |
| 50090-2144 | Sumatriptan | Sumatriptan Succinate | A-S Medication Solutions | ANDA | Current |
| 50090-2144 | Sumatriptan | Sumatriptan Succinate | A-S Medication Solutions | ANDA | Current |
| 50090-2144 | Sumatriptan | Sumatriptan Succinate | A-S Medication Solutions | ANDA | Current |
| 50090-2144 | Sumatriptan | Sumatriptan Succinate | A-S Medication Solutions | ANDA | Current |
| 50090-2144 | Sumatriptan | Sumatriptan Succinate | A-S Medication Solutions | ANDA | Current |
| 50436-0147 | Sumatriptan | Sumatriptan Succinate | Unit Dose Services | ANDA | Current |
| 53002-1562 | Sumatriptan | Sumatriptan Succinate | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-1562 | Sumatriptan | Sumatriptan Succinate | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-2592 | Sumatriptan | Sumatriptan Succinate | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-2592 | Sumatriptan | Sumatriptan Succinate | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-2593 | Sumatriptan | Sumatriptan Succinate | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-2593 | Sumatriptan | Sumatriptan Succinate | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 55700-759 | Sumatriptan | Sumatriptan Succinate | Quality Care Products, LLC | ANDA | Current |
| 55700-759 | Sumatriptan | Sumatriptan Succinate | Quality Care Products, LLC | ANDA | Current |
| 55700-889 | Sumatriptan | Sumatriptan Succinate | Quality Care Products, LLC | ANDA | Current |
| 55700-899 | Sumatriptan | Sumatriptan Succinate | Quality Care Products, LLC | ANDA | Current |
| 55700-936 | Sumatriptan | Sumatriptan Succinate | Quality Care Products, LLC | ANDA | Current |
| 55700-936 | Sumatriptan | Sumatriptan Succinate | Quality Care Products, LLC | ANDA | Current |
| 61919-300 | SUMATRIPTAN | sumatriptan succinate tablet | DIRECT RX | ANDA | Current |
| 61919-950 | IMITREX | SUMATRIPTAN | DIRECTRX | ANDA | Current |
| 63187-797 | Sumatriptan | Sumatriptan Succinate | Proficient Rx LP | ANDA | Current |
| 63187-797 | Sumatriptan | Sumatriptan Succinate | Proficient Rx LP | ANDA | Current |
| 63187-797 | Sumatriptan | Sumatriptan Succinate | Proficient Rx LP | ANDA | Current |
| 63187-797 | Sumatriptan | Sumatriptan Succinate | Proficient Rx LP | ANDA | Current |
| 63187-931 | Sumatriptan | Sumatriptan Succinate | Proficient Rx LP | ANDA | Current |
| 63187-931 | Sumatriptan | Sumatriptan Succinate | Proficient Rx LP | ANDA | Current |
| 63187-969 | Sumatriptan | Sumatriptan Succinate | Proficient Rx LP | ANDA | Current |
| 63187-969 | Sumatriptan | Sumatriptan Succinate | Proficient Rx LP | ANDA | Current |
| 63187-969 | Sumatriptan | Sumatriptan Succinate | Proficient Rx LP | ANDA | Current |
| 63187-969 | Sumatriptan | Sumatriptan Succinate | Proficient Rx LP | ANDA | Current |
| 63629-8134 | Sumatriptan | Sumatriptan Succinate | Bryant Ranch Prepack | ANDA | Current |
| 63629-8188 | Sumatriptan | Sumatriptan Succinate | Bryant Ranch Prepack | ANDA | Current |
| 63629-8188 | Sumatriptan | Sumatriptan Succinate | Bryant Ranch Prepack | ANDA | Current |
| 65862-146 | Sumatriptan | Sumatriptan Succinate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-146 | Sumatriptan | Sumatriptan Succinate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-146 | Sumatriptan | Sumatriptan Succinate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-146 | Sumatriptan | Sumatriptan Succinate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-146 | Sumatriptan | Sumatriptan Succinate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-147 | Sumatriptan | Sumatriptan Succinate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-147 | Sumatriptan | Sumatriptan Succinate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-147 | Sumatriptan | Sumatriptan Succinate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-147 | Sumatriptan | Sumatriptan Succinate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-147 | Sumatriptan | Sumatriptan Succinate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-148 | Sumatriptan | Sumatriptan Succinate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-148 | Sumatriptan | Sumatriptan Succinate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-148 | Sumatriptan | Sumatriptan Succinate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-148 | Sumatriptan | Sumatriptan Succinate | Aurobindo Pharma Limited | ANDA | Current |
| 65862-148 | Sumatriptan | Sumatriptan Succinate | Aurobindo Pharma Limited | ANDA | Current |
| 68071-3350 | Sumatriptan | Sumatriptan Succinate | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-3350 | Sumatriptan | Sumatriptan Succinate | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4061 | Sumatriptan | Sumatriptan Succinate U-D | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4061 | Sumatriptan | Sumatriptan Succinate U-D | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4815 | Sumatriptan | Sumatriptan Succinate | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4815 | Sumatriptan | Sumatriptan Succinate | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5072 | Sumatriptan | Sumatriptan Succinate | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5072 | Sumatriptan | Sumatriptan Succinate | NuCare Pharmaceuticals,Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 9143 | ORIG | 2009-08-14 |