Details for New Drug Application (NDA): 077214
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The generic ingredient in ZOLPIDEM TARTRATE is zolpidem tartrate. There are thirty-three drug master file entries for this compound. Forty-five suppliers are listed for this compound. Additional details are available on the zolpidem tartrate profile page.
Summary for 077214
Tradename: | ZOLPIDEM TARTRATE |
Applicant: | Acme Labs |
Ingredient: | zolpidem tartrate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 077214
Mechanism of Action | GABA A Agonists GABA A Receptor Positive Modulators |
Physiological Effect | Central Nervous System Depression |
Suppliers and Packaging for NDA: 077214
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ZOLPIDEM TARTRATE | zolpidem tartrate | TABLET;ORAL | 077214 | ANDA | Bryant Ranch Prepack | 63629-1170 | 63629-1170-1 | 100 TABLET in 1 BOTTLE (63629-1170-1) |
ZOLPIDEM TARTRATE | zolpidem tartrate | TABLET;ORAL | 077214 | ANDA | Bryant Ranch Prepack | 63629-1171 | 63629-1171-1 | 100 TABLET in 1 BOTTLE (63629-1171-1) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Apr 23, 2007 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Apr 23, 2007 | TE: | AB | RLD: | No |
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