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Details for New Drug Application (NDA): 090153
The generic ingredient in ZOLPIDEM TARTRATE is zolpidem tartrate. There are thirty-two drug master file entries for this compound. Sixty-five suppliers are listed for this compound. Additional details are available on the zolpidem tartrate profile page.
Summary for 090153
Tradename: | ZOLPIDEM TARTRATE |
Applicant: | Actavis Labs Fl Inc |
Ingredient: | zolpidem tartrate |
Patents: | 0 |
Therapeutic Class: | Sedatives/Hypnotics |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 090153
Ingredient-type | Pyridines |
Mechanism of Action | GABA A Agonists |
Physiological Effect | Central Nervous System Depression |
Suppliers and Packaging for NDA: 090153
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ZOLPIDEM TARTRATE | zolpidem tartrate | TABLET, EXTENDED RELEASE;ORAL | 090153 | ANDA | Actavis Pharma, Inc. | 0591-2281 | N | 0591-2281-10 |
ZOLPIDEM TARTRATE | zolpidem tartrate | TABLET, EXTENDED RELEASE;ORAL | 090153 | ANDA | Actavis Pharma, Inc. | 0591-2281 | N | 0591-2281-30 |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 6.25MG | ||||
Approval Date: | Mar 25, 2013 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 12.5MG | ||||
Approval Date: | Mar 25, 2013 | TE: | AB | RLD: | No |
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