Details for New Drug Application (NDA): 203019
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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 203019
Tradename: | ZOLMITRIPTAN |
Applicant: | Zydus Pharms |
Ingredient: | zolmitriptan |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 203019
Mechanism of Action | Serotonin 1b Receptor Agonists Serotonin 1d Receptor Agonists |
Suppliers and Packaging for NDA: 203019
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ZOLMITRIPTAN | zolmitriptan | TABLET;ORAL | 203019 | ANDA | Zydus Lifesciences Limited | 65841-765 | 65841-765-86 | 1 BLISTER PACK in 1 CARTON (65841-765-86) / 6 TABLET, FILM COATED in 1 BLISTER PACK |
ZOLMITRIPTAN | zolmitriptan | TABLET;ORAL | 203019 | ANDA | Zydus Lifesciences Limited | 65841-766 | 65841-766-82 | 1 BLISTER PACK in 1 CARTON (65841-766-82) / 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: | Jul 11, 2018 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Jul 11, 2018 | TE: | AB | RLD: | No |
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