DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 090153
NDA 090153 describes ZOLPIDEM TARTRATE, which is a drug marketed by Actavis Elizabeth, Actavis Labs Fl Inc, Anchen Pharms, Apotex Inc, Lupin Ltd, Sandoz, Sun Pharma Global, Synthon Pharms, Acme Labs, Aurobindo Pharma, Cipla Ltd, Dr Reddys Labs Ltd, Hikma, Invagen Pharms, Mylan, Mylan Pharms Inc, Sandoz Inc, Sun Pharm Inds Inc, Sun Pharm Inds Ltd, Sun Pharm Industries, Teva, Torrent Pharms, Vintage, Vivimed Global, Watson Labs, Wockhardt, Yung Shin Pharm, Dr Reddys Labs Inc, Novel Labs Inc, Par Form, and Par Pharm Inc, and is included in thirty-four NDAs. It is available from fifty-seven suppliers. Additional details are available on the ZOLPIDEM TARTRATE profile page.
The generic ingredient in ZOLPIDEM TARTRATE is zolpidem tartrate. There are thirty-three drug master file entries for this compound. Sixty-three suppliers are listed for this compound. Additional details are available on the zolpidem tartrate profile page.
The generic ingredient in ZOLPIDEM TARTRATE is zolpidem tartrate. There are thirty-three drug master file entries for this compound. Sixty-three 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 |
| 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 | 0591-2281-10 | 1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0591-2281-10) |
| ZOLPIDEM TARTRATE | zolpidem tartrate | TABLET, EXTENDED RELEASE;ORAL | 090153 | ANDA | Actavis Pharma, Inc. | 0591-2281 | 0591-2281-30 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (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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