Details for New Drug Application (NDA): 201779
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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 201779
Tradename: | ZOLMITRIPTAN |
Applicant: | Glenmark Pharms Ltd |
Ingredient: | zolmitriptan |
Patents: | 0 |
Pharmacology for NDA: 201779
Mechanism of Action | Serotonin 1b Receptor Agonists Serotonin 1d Receptor Agonists |
Suppliers and Packaging for NDA: 201779
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ZOLMITRIPTAN | zolmitriptan | TABLET;ORAL | 201779 | ANDA | BluePoint Laboratories | 68001-249 | 68001-249-01 | 1 BLISTER PACK in 1 CARTON (68001-249-01) / 6 TABLET, FILM COATED in 1 BLISTER PACK (68001-249-19) |
ZOLMITRIPTAN | zolmitriptan | TABLET;ORAL | 201779 | ANDA | BluePoint Laboratories | 68001-250 | 68001-250-01 | 1 BLISTER PACK in 1 CARTON (68001-250-01) / 3 TABLET, FILM COATED in 1 BLISTER PACK (68001-250-18) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;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;ORAL | Strength | 5MG | ||||
Approval Date: | May 14, 2013 | TE: | AB | RLD: | No |
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