Details for New Drug Application (NDA): 020626
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The generic ingredient in IMITREX is sumatriptan. There are twenty-four drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the sumatriptan profile page.
Summary for 020626
Tradename: | IMITREX |
Applicant: | Glaxosmithkline |
Ingredient: | sumatriptan |
Patents: | 0 |
Pharmacology for NDA: 020626
Mechanism of Action | Serotonin 1b Receptor Agonists Serotonin 1d Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 020626
Suppliers and Packaging for NDA: 020626
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
IMITREX | sumatriptan | SPRAY;NASAL | 020626 | NDA | GlaxoSmithKline LLC | 0173-0524 | 0173-0524-00 | 6 CONTAINER in 1 BOX (0173-0524-00) / 1 SPRAY in 1 CONTAINER |
IMITREX | sumatriptan | SPRAY;NASAL | 020626 | NDA AUTHORIZED GENERIC | Prasco Laboratories | 66993-081 | 66993-081-69 | 6 CONTAINER in 1 BOX (66993-081-69) / 100 uL in 1 CONTAINER |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SPRAY;NASAL | Strength | 5MG/SPRAY | ||||
Approval Date: | Aug 26, 1997 | TE: | AB | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | SPRAY;NASAL | Strength | 10MG/SPRAY | ||||
Approval Date: | Aug 26, 1997 | TE: | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | SPRAY;NASAL | Strength | 20MG/SPRAY | ||||
Approval Date: | Aug 26, 1997 | TE: | AB | RLD: | Yes |
Expired US Patents for NDA 020626
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Glaxosmithkline | IMITREX | sumatriptan | SPRAY;NASAL | 020626-003 | Aug 26, 1997 | ⤷ Sign Up | ⤷ Sign Up |
Glaxosmithkline | IMITREX | sumatriptan | SPRAY;NASAL | 020626-003 | Aug 26, 1997 | ⤷ Sign Up | ⤷ Sign Up |
Glaxosmithkline | IMITREX | sumatriptan | SPRAY;NASAL | 020626-001 | Aug 26, 1997 | ⤷ Sign Up | ⤷ Sign Up |
Glaxosmithkline | IMITREX | sumatriptan | SPRAY;NASAL | 020626-001 | Aug 26, 1997 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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