Details for New Drug Application (NDA): 207021
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NDA 207021 describes ZOLMITRIPTAN, which is a drug marketed by Padagis Israel, Alembic, Apotex Inc, Glenmark Pharms Ltd, Jubilant Generics, Macleods Pharms Ltd, Rising, Zydus Pharms Usa Inc, Ajanta Pharma Ltd, Ani Pharms, Aurobindo Pharma, Invagen Pharms, Natco Pharma Usa, Orbion Pharms, Pld Acquisitions Llc, Somerset Theraps Llc, Sun Pharma Global, and Zydus Pharms, and is included in twenty-three NDAs. It is available from nineteen suppliers. Additional details are available on the ZOLMITRIPTAN profile page.
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.
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 207021
| Tradename: | ZOLMITRIPTAN |
| Applicant: | Aurobindo Pharma |
| Ingredient: | zolmitriptan |
| Patents: | 0 |
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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