Details for New Drug Application (NDA): 078989
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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.
Pharmacology for NDA: 078989
Mechanism of Action | GABA A Agonists |
Physiological Effect | Central Nervous System Depression |
Suppliers and Packaging for NDA: 078989
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ZALEPLON | zaleplon | CAPSULE;ORAL | 078989 | ANDA | Unichem Pharmaceuticals (USA), Inc. | 29300-131 | 29300-131-01 | 100 CAPSULE in 1 BOTTLE, PLASTIC (29300-131-01) |
ZALEPLON | zaleplon | CAPSULE;ORAL | 078989 | ANDA | Unichem Pharmaceuticals (USA), Inc. | 29300-131 | 29300-131-05 | 500 CAPSULE in 1 BOTTLE, PLASTIC (29300-131-05) |
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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