Details for New Drug Application (NDA): 212469
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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 212469
Tradename: | ZOLMITRIPTAN |
Applicant: | Padagis Israel |
Ingredient: | zolmitriptan |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 212469
Mechanism of Action | Serotonin 1b Receptor Agonists Serotonin 1d Receptor Agonists |
Suppliers and Packaging for NDA: 212469
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ZOLMITRIPTAN | zolmitriptan | SPRAY;NASAL | 212469 | ANDA | Padagis Israel Pharmaceuticals Ltd | 45802-711 | 45802-711-91 | 6 BOTTLE, SPRAY in 1 CARTON (45802-711-91) / 1 SPRAY in 1 BOTTLE, SPRAY (45802-711-00) |
ZOLMITRIPTAN | zolmitriptan | SPRAY;NASAL | 212469 | ANDA | Bryant Ranch Prepack | 63629-9575 | 63629-9575-1 | 6 BOTTLE, SPRAY in 1 CARTON (63629-9575-1) / 1 SPRAY in 1 BOTTLE, SPRAY (63629-9575-2) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SPRAY;NASAL | Strength | 2.5MG/SPRAY | ||||
Approval Date: | Sep 30, 2021 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | SPRAY;NASAL | Strength | 5MG/SPRAY | ||||
Approval Date: | Sep 30, 2021 | TE: | AB | RLD: | No |
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