Active ingredient
Sumatriptan
121 finished FDA listings contain Sumatriptan as their only active ingredient; 5 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- SUMATRIPTAN, SUMATRIPTAN SUCCINATE
- Dosage forms
- Injection, Injection, Solution, Solution, Spray, Tablet, Tablet, Film Coated
- Routes
- Nasal, Oral, Subcutaneous
- Manufacturers / labelers
- 44
- Strengths listed
- 10 mg/.1ml · 100 mg/1 · 20 mg/.1ml · 20 mg/1 · 20 mg/100ul · 25 mg/1 · 3 mg/.5ml · 4 mg/.5ml · 5 mg/.1ml · 5 mg/1 · 5 mg/100ul · 50 mg/1 · 6 mg/.5ml
- Brand names in FDA listings
- Imitrex, Sumatriptan, Tosymra, Zembrace Symtouch
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 37418
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 020080 | GLAXOSMITHKLINE | 1992-12-28 | 3 |
| NDA 020132 | GLAXOSMITHKLINE | 1995-06-01 | 3 |
| NDA 020626 | GLAXOSMITHKLINE | 1997-08-26 | 2 |
| ANDA 078593 | WOCKHARDT BIO AG | 2009-02-06 | 1 |
| ANDA 076572 | SUN PHARM INDS LTD | 2009-02-09 | 2 |
| ANDA 079242 | FRESENIUS KABI USA | 2009-03-02 | 1 |
| ANDA 078327 | AUROBINDO PHARMA | 2009-08-10 | 31 |
| ANDA 078284 | ORBION PHARMS | 2009-08-10 | 12 |
| ANDA 076847 | DR REDDYS LABS INC | 2009-08-10 | 9 |
| ANDA 078295 | SUN PHARM INDS | 2009-08-10 | 8 |
| ANDA 077744 | MYLAN | 2009-08-10 | 6 |
| ANDA 076554 | SUN PHARM INDS LTD | 2009-08-10 | 3 |
| ANDA 090314 | ONESOURCE SPECIALTY | 2010-06-10 | 4 |
| ANDA 090641 | ONESOURCE SPECIALTY | 2010-07-28 | 1 |
| ANDA 090358 | SUN PHARM | 2011-06-21 | 1 |
| ANDA 202758 | EUGIA PHARMA | 2013-04-23 | 3 |
| ANDA 200183 | HIKMA | 2013-09-16 | 2 |
| ANDA 090495 | DR REDDYS | 2014-01-29 | 4 |
| NDA 208223 | TONIX MEDS | 2016-01-28 | 1 |
| ANDA 204841 | LANNETT CO INC | 2016-02-19 | 2 |
| NDA 210884 | TONIX MEDS | 2019-01-25 | 2 |
| ANDA 213650 | PERRIGO UK FINCO | 2020-09-21 | 1 |
| ANDA 213465 | PADAGIS ISRAEL | 2020-09-21 | 3 |
| ANDA 208967 | REGCON HOLDINGS | 2021-02-17 | 1 |
| ANDA 214209 | CIPLA | 2021-02-22 | 1 |
| ANDA 213998 | CAPLIN | 2021-07-13 | 5 |
| ANDA 207101 | BAXTER HLTHCARE CORP | 2023-01-19 | 1 |
| ANDA 215651 | ONESOURCE SPECIALTY | 2024-11-21 | 1 |
| ANDA 219036 | VKT PHARMA | 2024-12-31 | 3 |
| ANDA 213518 | ALEMBIC | 2025-11-06 | 4 |
Official labeling on DailyMed
- SUMATRIPTAN SUCCINATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] · version 16 · 2026-09-10
- SUMATRIPTAN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.] · version 4 · 2026-09-07
- SUMATRIPTAN (SUMATRIPTAN SUCCINATE) TABLET [PREFERRED PHARMACEUTICALS, INC.] · version 10 · 2026-09-07
- SUMATRIPTAN (SUMATRIPTAN SUCCINATE) TABLET [PREFERRED PHARMACEUTICALS INC.] · version 10 · 2026-09-04
- SUMATRIPTAN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.] · version 3 · 2026-09-04
- IMITREX (SUMATRIPTAN) TABLET, FILM COATED [GLAXOSMITHKLINE LLC] · version 24 · 2026-08-13
- IMITREX (SUMATRIPTAN) INJECTION [GLAXOSMITHKLINE LLC] · version 30 · 2026-08-12
- SUMATRIPTAN SPRAY [PRASCO LABORATORIES] · version 9 · 2026-08-11
- SUMATRIPTAN SUCCINATE INJECTION [ALEMBIC PHARMACEUTICALS INC.] · version 7 · 2026-08-07
- SUMATRIPTAN INJECTION, SOLUTION [SPORTPHARM LLC] · version 1 · 2026-07-24
- SUMATRIPTAN SUCCINATE INJECTION [SPORTPHARM LLC] · version 1 · 2026-07-13
- SUMATRIPTAN INJECTION, SOLUTION [ARMAS PHARMACEUTICALS INC.] · version 2 · 2026-06-02
Showing the 12 most recent of 86 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.