Details for New Drug Application (NDA): 202560
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The generic ingredient in ZOLMITRIPTAN is zolmitriptan. There are twenty drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the zolmitriptan profile page.
Summary for 202560
Tradename: | ZOLMITRIPTAN |
Applicant: | Glenmark Pharms Ltd |
Ingredient: | zolmitriptan |
Patents: | 0 |
Pharmacology for NDA: 202560
Mechanism of Action | Serotonin 1b Receptor Agonists Serotonin 1d Receptor Agonists |
Suppliers and Packaging for NDA: 202560
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ZOLMITRIPTAN | zolmitriptan | TABLET, ORALLY DISINTEGRATING;ORAL | 202560 | ANDA | Glenmark Pharmaceuticals Inc., USA | 68462-499 | 68462-499-76 | 1 BLISTER PACK in 1 CARTON (68462-499-76) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (68462-499-40) |
ZOLMITRIPTAN | zolmitriptan | TABLET, ORALLY DISINTEGRATING;ORAL | 202560 | ANDA | Glenmark Pharmaceuticals Inc., USA | 68462-500 | 68462-500-33 | 1 BLISTER PACK in 1 CARTON (68462-500-33) / 3 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (68462-500-40) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 2.5MG | ||||
Approval Date: | May 14, 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 14, 2013 | TE: | AB | RLD: | No |
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