Details for New Drug Application (NDA): 207021
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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 207021
Tradename: | ZOLMITRIPTAN |
Applicant: | Aurobindo Pharma |
Ingredient: | zolmitriptan |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 207021
Mechanism of Action | Serotonin 1b Receptor Agonists Serotonin 1d Receptor Agonists |
Suppliers and Packaging for NDA: 207021
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ZOLMITRIPTAN | zolmitriptan | TABLET;ORAL | 207021 | ANDA | Rising Pharma Holdings, Inc. | 16571-803 | 16571-803-16 | 1 BLISTER PACK in 1 CARTON (16571-803-16) / 6 TABLET, FILM COATED in 1 BLISTER PACK |
ZOLMITRIPTAN | zolmitriptan | TABLET;ORAL | 207021 | ANDA | Rising Pharma Holdings, Inc. | 16571-804 | 16571-804-13 | 1 BLISTER PACK in 1 CARTON (16571-804-13) / 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: | May 11, 2016 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | May 11, 2016 | TE: | AB | RLD: | No |
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