Application 206019
- Type
- ANDA
- Sponsor
- IPCA LABS LTD
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 |
|---|---|---|---|---|---|---|---|
| A206019-001 | SUMATRIPTAN SUCCINATE | SUMATRIPTAN SUCCINATE | EQ 25MG BASE | TABLET / ORAL | AB | 2025-07-15 | |
| A206019-002 | SUMATRIPTAN SUCCINATE | SUMATRIPTAN SUCCINATE | EQ 50MG BASE | TABLET / ORAL | AB | 2025-07-15 | |
| A206019-003 | SUMATRIPTAN SUCCINATE | SUMATRIPTAN SUCCINATE | EQ 100MG BASE | TABLET / ORAL | AB | 2025-07-15 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A206019-001 | AB |
| A206019-002 | AB |
| A206019-003 | 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 | A206019-001 | SUMATRIPTAN SUCCINATE | EQ 25MG BASE | TABLET / ORAL | AB | 2025-07-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A206019-002 | SUMATRIPTAN SUCCINATE | EQ 50MG BASE | TABLET / ORAL | AB | 2025-07-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A206019-003 | SUMATRIPTAN SUCCINATE | EQ 100MG BASE | TABLET / ORAL | AB | 2025-07-15 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206019-001 | SUMATRIPTAN SUCCINATE | EQ 25MG BASE | TABLET / ORAL | AB | 2025-07-15 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206019-002 | SUMATRIPTAN SUCCINATE | EQ 50MG BASE | TABLET / ORAL | AB | 2025-07-15 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206019-003 | SUMATRIPTAN SUCCINATE | EQ 100MG BASE | TABLET / ORAL | AB | 2025-07-15 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A206019-001 | SUMATRIPTAN SUCCINATE | EQ 25MG BASE | TABLET / ORAL | AB | 2025-07-15 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A206019-002 | SUMATRIPTAN SUCCINATE | EQ 50MG BASE | TABLET / ORAL | AB | 2025-07-15 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A206019-003 | SUMATRIPTAN SUCCINATE | EQ 100MG BASE | TABLET / ORAL | AB | 2025-07-15 | 6a471c1ec25d… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A206019-001 | SUMATRIPTAN SUCCINATE | EQ 25MG BASE | TABLET / ORAL | AB | 2025-07-15 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A206019-002 | SUMATRIPTAN SUCCINATE | EQ 50MG BASE | TABLET / ORAL | AB | 2025-07-15 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A206019-003 | SUMATRIPTAN SUCCINATE | EQ 100MG BASE | TABLET / ORAL | AB | 2025-07-15 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A206019-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A206019-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A206019-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206019-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206019-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206019-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A206019-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A206019-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A206019-003 | AB | 1 | 6a471c1ec25d… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A206019-001 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A206019-002 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A206019-003 | AB | 1 | a50c72e98297… |
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 Succinate | SUMATRIPTAN SUCCINATE | Sportpharm LLC | 7d3602a1-1cd5-41c2-a0a3-3d20e90a92fa | 2026-07-09 | Warnings, Adverse reactions | Sumatriptan Succinate SUMATRIPTAN SUCCINATE |
| sumatriptan succinate | SUMATRIPTAN SUCCINATE | Sun Pharmaceutical Industries, Inc. | 9485cc30-15e8-4b53-876d-db317145474b | 2026-06-25 | Warnings, Adverse reactions | sumatriptan succinate SUMATRIPTAN SUCCINATE |
| Sumatriptan | SUMATRIPTAN SUCCINATE | REMEDYREPACK INC. | 73c9ac06-b55e-41e0-90ec-deb250f37eb5 | 2026-05-19 | Warnings, Adverse reactions | SUMATRIPTAN SUCCINATE |
| Sumatriptan | SUMATRIPTAN SUCCINATE | Aurobindo Pharma Limited | b2503fff-c978-4efa-b1b4-d7740b6b26f2 | 2026-05-12 | Warnings, Adverse reactions | SUMATRIPTAN SUCCINATE |
| Sumatriptan | SUMATRIPTAN SUCCINATE | Sportpharm LLC | d071aef6-a5bd-4f68-ba6d-03004466897c | 2026-04-24 | Warnings, Adverse reactions | SUMATRIPTAN SUCCINATE |
| Sumatriptan Succinate | SUMATRIPTAN SUCCINATE | Golden State Medical Supply, Inc. | 1bf70380-8272-4c0d-8841-d39ef2772351 | 2026-04-15 | Warnings, Adverse reactions | Sumatriptan Succinate SUMATRIPTAN SUCCINATE |
| Sumatriptan Succinate | SUMATRIPTAN SUCCINATE | Dr. Reddy's Laboratories Limited | ac80d018-6abf-2e41-ddea-90b4ff9e9013 | 2026-03-21 | Warnings, Adverse reactions | Sumatriptan Succinate SUMATRIPTAN SUCCINATE |
| Sumatriptan | SUMATRIPTAN SUCCINATE | A-S Medication Solutions | 62ba6fef-467a-4500-993c-51907f12a67c | 2026-02-14 | Warnings, Adverse reactions | SUMATRIPTAN SUCCINATE |
| Sumatriptan | SUMATRIPTAN SUCCINATE | NorthStar Rx LLC | 84bfc4ba-4172-4adb-b963-4e0eb438c07a | 2026-02-13 | Warnings, Adverse reactions | SUMATRIPTAN SUCCINATE |
| SUMATRIPTAN SUCCINATE | SUMATRIPTAN SUCCINATE | Alembic Pharmaceuticals Inc. | 0e8b65f7-9d3b-42f2-8d7e-69b143365980 | 2026-01-29 | Warnings, Adverse reactions | SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE |
| Sumatriptan Succinate | SUMATRIPTAN SUCCINATE | Dr. Reddys Laboratories Inc., | 8fef1176-7a38-eca3-22ca-83efe5ca6620 | 2026-01-21 | Warnings, Adverse reactions | Sumatriptan Succinate SUMATRIPTAN SUCCINATE |
| ZEMBRACE SYMTOUCH | SUMATRIPTAN SUCCINATE | Upsher-Smith laboratories, LLC | 6e5b104f-2b9e-416e-92fb-ef1bdaea867d | 2026-01-09 | Warnings, Adverse reactions | SUMATRIPTAN SUCCINATE |
| Sumatriptan Succinate | SUMATRIPTAN SUCCINATE | Sun Pharmaceutical Industries, Inc. | f235152e-dd8d-4679-9d9f-404fe5ff4fba | 2026-01-08 | Warnings, Adverse reactions | Sumatriptan Succinate SUMATRIPTAN SUCCINATE |
| Sumatriptan Succinate | SUMATRIPTAN SUCCINATE | Mylan Pharmaceuticals Inc. | 1d2cd01c-05e7-44cf-a71d-0f474e826b7e | 2026-01-01 | Warnings, Adverse reactions | Sumatriptan Succinate SUMATRIPTAN SUCCINATE |
| SUMATRIPTAN SUCCINATE | SUMATRIPTAN SUCCINATE | Alembic Pharmaceuticals Limited | 16b7e44d-afa0-4177-80ef-c3ae9a78a4e1 | 2025-11-17 | Warnings, Adverse reactions | SUMATRIPTAN SUCCINATE SUMATRIPTAN SUCCINATE |
| Sumatriptan | SUMATRIPTAN SUCCINATE | Preferred Pharmaceuticals, Inc. | f2e7d756-1e12-462a-a43f-a9d860b11ee8 | 2025-09-25 | Warnings, Adverse reactions | SUMATRIPTAN SUCCINATE |
| Sumatriptan | SUMATRIPTAN SUCCINATE | Preferred Pharmaceuticals, Inc. | bf9fd9fe-095b-4478-bd2e-a5534af07761 | 2025-09-25 | Warnings, Adverse reactions | SUMATRIPTAN SUCCINATE |
| Sumatriptan | SUMATRIPTAN SUCCINATE | Preferred Pharmaceuticals Inc. | baf37e8c-d414-4ca7-a366-97dc202372ff | 2025-09-25 | Warnings, Adverse reactions | SUMATRIPTAN SUCCINATE |
| Zembrace SymTouch | SUMATRIPTAN SUCCINATE | Tonix Medicines, Inc. | 3eb49807-fa9d-4a0d-9a3c-76de5b23b01b | 2025-02-28 | Warnings, Adverse reactions | SUMATRIPTAN SUCCINATE |
| Sumatriptan | SUMATRIPTAN SUCCINATE | NuCare Pharmaceuticals, Inc. | 2efd4269-5657-9669-e063-6394a90a583a | 2025-02-25 | Warnings, Adverse reactions | SUMATRIPTAN SUCCINATE |