Details for New Drug Application (NDA): 077903
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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 077903
Tradename: | ZOLPIDEM TARTRATE |
Applicant: | Torrent Pharms |
Ingredient: | zolpidem tartrate |
Patents: | 0 |
Pharmacology for NDA: 077903
Mechanism of Action | GABA A Receptor Positive Modulators GABA A Agonists |
Physiological Effect | Central Nervous System Depression |
Suppliers and Packaging for NDA: 077903
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ZOLPIDEM TARTRATE | zolpidem tartrate | TABLET;ORAL | 077903 | ANDA | Major Pharmaceuticals | 0904-6082 | 0904-6082-61 | 100 BLISTER PACK in 1 CARTON (0904-6082-61) / 1 TABLET in 1 BLISTER PACK |
ZOLPIDEM TARTRATE | zolpidem tartrate | TABLET;ORAL | 077903 | ANDA | Torrent Pharmaceuticals Limited | 13668-007 | 13668-007-01 | 100 TABLET in 1 BOTTLE (13668-007-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Aug 17, 2007 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Aug 17, 2007 | TE: | AB | RLD: | No |
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