Details for New Drug Application (NDA): 090374
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NDA 090374 describes ZALEPLON, which is a drug marketed by Aurobindo Pharma, Chartwell Molecular, Hikma, Hikma Pharms, Natco Pharma, Orbion Pharms, Teva Pharms, Unichem, and Upsher Smith Labs, and is included in ten NDAs. It is available from ten suppliers. Additional details are available on the ZALEPLON profile page.
The generic ingredient in ZALEPLON is zaleplon. There are twelve drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the zaleplon profile page.
The generic ingredient in ZALEPLON is zaleplon. There are twelve drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the zaleplon profile page.
Summary for 090374
| Tradename: | ZALEPLON |
| Applicant: | Orbion Pharms |
| Ingredient: | zaleplon |
| Patents: | 0 |
Pharmacology for NDA: 090374
| Mechanism of Action | GABA A Agonists |
| Physiological Effect | Central Nervous System Depression |
Suppliers and Packaging for NDA: 090374
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ZALEPLON | zaleplon | CAPSULE;ORAL | 090374 | ANDA | Preferred Pharmaceuticals Inc. | 68788-8725 | 68788-8725-1 | 100 CAPSULE in 1 BOTTLE (68788-8725-1) |
| ZALEPLON | zaleplon | CAPSULE;ORAL | 090374 | ANDA | Preferred Pharmaceuticals Inc. | 68788-8725 | 68788-8725-2 | 20 CAPSULE in 1 BOTTLE (68788-8725-2) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 5MG | ||||
| Approval Date: | Sep 17, 2009 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 10MG | ||||
| Approval Date: | Sep 17, 2009 | TE: | AB | RLD: | No | ||||
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