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-one 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 |
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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