Details for New Drug Application (NDA): 020626
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NDA 020626 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. Nine 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. Nine 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 |
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 AUTHORIZED GENERIC | Prasco Laboratories | 66993-081 | 66993-081-69 | 6 CONTAINER in 1 BOX (66993-081-69) / 100 uL in 1 CONTAINER |
| IMITREX | sumatriptan | SPRAY;NASAL | 020626 | NDA AUTHORIZED GENERIC | Prasco Laboratories | 66993-082 | 66993-082-69 | 6 CONTAINER in 1 BOX (66993-082-69) / 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 | 020626-002 | Aug 26, 1997 | ⤷ Get Started Free | ⤷ Get Started Free |
| Glaxosmithkline | IMITREX | sumatriptan | SPRAY;NASAL | 020626-003 | Aug 26, 1997 | ⤷ Get Started Free | ⤷ Get Started Free |
| Glaxosmithkline | IMITREX | sumatriptan | SPRAY;NASAL | 020626-003 | Aug 26, 1997 | ⤷ Get Started Free | ⤷ Get Started Free |
| Glaxosmithkline | IMITREX | sumatriptan | SPRAY;NASAL | 020626-001 | Aug 26, 1997 | ⤷ Get Started Free | ⤷ Get Started Free |
| Glaxosmithkline | IMITREX | sumatriptan | SPRAY;NASAL | 020626-002 | Aug 26, 1997 | ⤷ Get Started Free | ⤷ Get Started Free |
| Glaxosmithkline | IMITREX | sumatriptan | SPRAY;NASAL | 020626-003 | Aug 26, 1997 | ⤷ Get Started Free | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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