Details for New Drug Application (NDA): 090381
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NDA 090381 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 four 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. Four 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. Four suppliers are listed for this compound. Additional details are available on the naratriptan hydrochloride profile page.
Summary for 090381
| Tradename: | NARATRIPTAN |
| Applicant: | Hikma |
| Ingredient: | naratriptan hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 090381
| Mechanism of Action | Serotonin 1b Receptor Agonists Serotonin 1d Receptor Agonists |
Suppliers and Packaging for NDA: 090381
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NARATRIPTAN | naratriptan hydrochloride | TABLET;ORAL | 090381 | ANDA | Hikma Pharmaceuticals USA Inc. | 0054-0278 | 0054-0278-03 | 9 TABLET in 1 BOTTLE (0054-0278-03) |
| NARATRIPTAN | naratriptan hydrochloride | TABLET;ORAL | 090381 | ANDA | Hikma Pharmaceuticals USA Inc. | 0054-0279 | 0054-0279-03 | 9 TABLET in 1 BOTTLE (0054-0279-03) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 1MG BASE | ||||
| Approval Date: | Jul 7, 2010 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 2.5MG BASE | ||||
| Approval Date: | Jul 7, 2010 | TE: | AB | RLD: | No | ||||
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