Details for New Drug Application (NDA): 201509
✉ Email this page to a colleague
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 201509
Tradename: | ZOLPIDEM TARTRATE |
Applicant: | Par Form |
Ingredient: | zolpidem tartrate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 201509
Mechanism of Action | GABA A Agonists |
Physiological Effect | Central Nervous System Depression |
Suppliers and Packaging for NDA: 201509
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ZOLPIDEM TARTRATE | zolpidem tartrate | TABLET;SUBLINGUAL | 201509 | ANDA | Par Pharmaceutical, Inc. | 49884-903 | 49884-903-52 | 10 TABLET in 1 BLISTER PACK (49884-903-52) |
ZOLPIDEM TARTRATE | zolpidem tartrate | TABLET;SUBLINGUAL | 201509 | ANDA | Par Pharmaceutical, Inc. | 49884-903 | 49884-903-55 | 30 TABLET in 1 CARTON (49884-903-55) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;SUBLINGUAL | Strength | 5MG | ||||
Approval Date: | Aug 1, 2016 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;SUBLINGUAL | Strength | 10MG | ||||
Approval Date: | Aug 1, 2016 | TE: | AB | RLD: | No |
Complete Access Available with Subscription