Details for New Drug Application (NDA): 204284
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The generic ingredient in ZOLMITRIPTAN is zolmitriptan. There are twenty drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the zolmitriptan profile page.
Summary for 204284
Tradename: | ZOLMITRIPTAN |
Applicant: | Invagen Pharms |
Ingredient: | zolmitriptan |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 204284
Mechanism of Action | Serotonin 1b Receptor Agonists Serotonin 1d Receptor Agonists |
Suppliers and Packaging for NDA: 204284
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ZOLMITRIPTAN | zolmitriptan | TABLET;ORAL | 204284 | ANDA | Cipla USA Inc. | 69097-863 | 69097-863-17 | 1 BLISTER PACK in 1 CARTON (69097-863-17) / 6 TABLET, FILM COATED in 1 BLISTER PACK |
ZOLMITRIPTAN | zolmitriptan | TABLET;ORAL | 204284 | ANDA | Cipla USA Inc. | 69097-864 | 69097-864-84 | 1 BLISTER PACK in 1 CARTON (69097-864-84) / 3 TABLET, FILM COATED in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2.5MG | ||||
Approval Date: | Apr 9, 2014 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Apr 9, 2014 | TE: | AB | RLD: | No |
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