Details for New Drug Application (NDA): 202890
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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 202890
Tradename: | ZOLMITRIPTAN |
Applicant: | Zydus Pharms Usa Inc |
Ingredient: | zolmitriptan |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 202890
Mechanism of Action | Serotonin 1b Receptor Agonists Serotonin 1d Receptor Agonists |
Suppliers and Packaging for NDA: 202890
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ZOLMITRIPTAN | zolmitriptan | TABLET, ORALLY DISINTEGRATING;ORAL | 202890 | ANDA | Zydus Lifesciences Limited | 65841-767 | 65841-767-01 | 100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (65841-767-01) |
ZOLMITRIPTAN | zolmitriptan | TABLET, ORALLY DISINTEGRATING;ORAL | 202890 | ANDA | Zydus Lifesciences Limited | 65841-767 | 65841-767-06 | 30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (65841-767-06) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 2.5MG | ||||
Approval Date: | May 15, 2013 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 5MG | ||||
Approval Date: | May 15, 2013 | TE: | AB | RLD: | No |
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