Details for New Drug Application (NDA): 205074
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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 205074
Tradename: | ZOLMITRIPTAN |
Applicant: | Alembic |
Ingredient: | zolmitriptan |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 205074
Mechanism of Action | Serotonin 1b Receptor Agonists Serotonin 1d Receptor Agonists |
Suppliers and Packaging for NDA: 205074
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ZOLMITRIPTAN | zolmitriptan | TABLET, ORALLY DISINTEGRATING;ORAL | 205074 | ANDA | Alembic Pharmaceuticals Limited | 46708-181 | 46708-181-06 | 6 BLISTER PACK in 1 CARTON (46708-181-06) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK |
ZOLMITRIPTAN | zolmitriptan | TABLET, ORALLY DISINTEGRATING;ORAL | 205074 | ANDA | Alembic Pharmaceuticals Limited | 46708-182 | 46708-182-03 | 3 BLISTER PACK in 1 CARTON (46708-182-03) / 3 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 2.5MG | ||||
Approval Date: | Dec 1, 2016 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 5MG | ||||
Approval Date: | Dec 1, 2016 | TE: | AB | RLD: | No |
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