Details for New Drug Application (NDA): 020132
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NDA 020132 describes IMITREX, which is a drug marketed by Glaxosmithkline and is included in three NDAs. It is available from two suppliers. Additional details are available on the IMITREX profile page.
The generic ingredient in IMITREX is sumatriptan. There are twenty-four drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the sumatriptan profile page.
The generic ingredient in IMITREX is sumatriptan. There are twenty-four drug master file entries for this compound. Eight 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 |
| Formulation / Manufacturing: | see details |
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 | ⤷ Try a Trial | ⤷ Try a Trial |
| Glaxosmithkline | IMITREX | sumatriptan succinate | TABLET;ORAL | 020132-003 | Jun 1, 1995 | ⤷ Try a Trial | ⤷ Try a Trial |
| Glaxosmithkline | IMITREX | sumatriptan succinate | TABLET;ORAL | 020132-002 | Jun 1, 1995 | ⤷ Try a Trial | ⤷ Try a Trial |
| Glaxosmithkline | IMITREX | sumatriptan succinate | TABLET;ORAL | 020132-002 | Jun 1, 1995 | ⤷ Try a Trial | ⤷ Try a Trial |
| Glaxosmithkline | IMITREX | sumatriptan succinate | TABLET;ORAL | 020132-003 | Jun 1, 1995 | ⤷ Try a Trial | ⤷ Try a Trial |
| Glaxosmithkline | IMITREX | sumatriptan succinate | TABLET;ORAL | 020132-002 | Jun 1, 1995 | ⤷ Try a Trial | ⤷ Try a Trial |
| Glaxosmithkline | IMITREX | sumatriptan succinate | TABLET;ORAL | 020132-003 | Jun 1, 1995 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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