Details for New Drug Application (NDA): 091441
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NDA 091441 describes NARATRIPTAN, which is a drug marketed by Ani Pharms, Apotex Corp, Aurobindo Pharma Usa, Chartwell Rx, Heritage, Hikma, Orbion Pharms, Padagis Us, and Sun Pharm Inds Ltd, and is included in nine NDAs. It is available from three suppliers. Additional details are available on the NARATRIPTAN profile page.
The generic ingredient in NARATRIPTAN is naratriptan hydrochloride. There are six drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the naratriptan hydrochloride profile page.
The generic ingredient in NARATRIPTAN is naratriptan hydrochloride. There are six drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the naratriptan hydrochloride profile page.
Summary for 091441
| Tradename: | NARATRIPTAN |
| Applicant: | Orbion Pharms |
| Ingredient: | naratriptan hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 091441
| Mechanism of Action | Serotonin 1b Receptor Agonists Serotonin 1d Receptor Agonists |
Suppliers and Packaging for NDA: 091441
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NARATRIPTAN | naratriptan hydrochloride | TABLET;ORAL | 091441 | ANDA | Bionpharma Inc. | 69452-340 | 69452-340-72 | 1 BLISTER PACK in 1 CARTON (69452-340-72) / 9 TABLET, FILM COATED in 1 BLISTER PACK (69452-340-60) |
| NARATRIPTAN | naratriptan hydrochloride | TABLET;ORAL | 091441 | ANDA | Bionpharma Inc. | 69452-341 | 69452-341-72 | 1 BLISTER PACK in 1 CARTON (69452-341-72) / 9 TABLET, FILM COATED in 1 BLISTER PACK (69452-341-60) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 1MG BASE | ||||
| Approval Date: | Apr 30, 2012 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 2.5MG BASE | ||||
| Approval Date: | Apr 30, 2012 | TE: | AB | RLD: | No | ||||
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