Details for New Drug Application (NDA): 078829
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NDA 078829 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 078829
| Tradename: | ZALEPLON |
| Applicant: | Aurobindo Pharma |
| Ingredient: | zaleplon |
| Patents: | 0 |
Pharmacology for NDA: 078829
| Mechanism of Action | GABA A Agonists |
| Physiological Effect | Central Nervous System Depression |
Suppliers and Packaging for NDA: 078829
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ZALEPLON | zaleplon | CAPSULE;ORAL | 078829 | ANDA | PD-Rx Pharmaceuticals, Inc. | 43063-505 | 43063-505-30 | 30 CAPSULE in 1 BOTTLE, PLASTIC (43063-505-30) |
| ZALEPLON | zaleplon | CAPSULE;ORAL | 078829 | ANDA | Rising Pharma Holdings, Inc. | 57237-239 | 57237-239-01 | 100 CAPSULE in 1 BOTTLE (57237-239-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 5MG | ||||
| Approval Date: | Jun 6, 2008 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 10MG | ||||
| Approval Date: | Jun 6, 2008 | TE: | AB | RLD: | No | ||||
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