Details for New Drug Application (NDA): 020132
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The generic ingredient in IMITREX is sumatriptan. There are twenty-four drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the sumatriptan profile page.
Summary for 020132
| Tradename: | IMITREX |
| Applicant: | Glaxosmithkline |
| Ingredient: | sumatriptan succinate |
| Patents: | 0 |
Pharmacology for NDA: 020132
| Mechanism of Action | Serotonin 1b Receptor Agonists Serotonin 1d Receptor Agonists |
Suppliers and Packaging for NDA: 020132
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| IMITREX | sumatriptan succinate | TABLET;ORAL | 020132 | NDA | GlaxoSmithKline LLC | 0173-0735 | 0173-0735-00 | 1 CARTON in 1 CARTON (0173-0735-00) / 1 BLISTER PACK in 1 CARTON / 9 TABLET, FILM COATED in 1 BLISTER PACK |
| IMITREX | sumatriptan succinate | TABLET;ORAL | 020132 | NDA | GlaxoSmithKline LLC | 0173-0736 | 0173-0736-01 | 1 CARTON in 1 CARTON (0173-0736-01) / 1 BLISTER PACK in 1 CARTON / 9 TABLET, FILM COATED in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 100MG BASE | ||||
| Approval Date: | Jun 1, 1995 | TE: | AB | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 25MG BASE | ||||
| Approval Date: | Jun 1, 1995 | TE: | AB | RLD: | Yes | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 50MG BASE | ||||
| Approval Date: | Jun 1, 1995 | TE: | AB | RLD: | Yes | ||||
Expired US Patents for NDA 020132
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Glaxosmithkline | IMITREX | sumatriptan succinate | TABLET;ORAL | 020132-003 | Jun 1, 1995 | 5,037,845*PED | ⤷ Get Started Free |
| Glaxosmithkline | IMITREX | sumatriptan succinate | TABLET;ORAL | 020132-001 | Jun 1, 1995 | 6,368,627*PED | ⤷ Get Started Free |
| Glaxosmithkline | IMITREX | sumatriptan succinate | TABLET;ORAL | 020132-001 | Jun 1, 1995 | 5,037,845*PED | ⤷ Get Started Free |
| Glaxosmithkline | IMITREX | sumatriptan succinate | TABLET;ORAL | 020132-002 | Jun 1, 1995 | 4,816,470*PED | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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