Details for New Drug Application (NDA): 204229
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NDA 204229 describes ZOLPIDEM TARTRATE, which is a drug marketed by Almatica, Actavis Elizabeth, Actavis Labs Fl Inc, Apotex, Breckenridge, Endo Operations, Lupin Ltd, Sandoz, Sun Pharm, Synthon Pharms, Acme Labs, Apotex Inc, Aurobindo Pharma, Chartwell Molecular, Dr Reddys Labs Ltd, Hikma, Invagen Pharms, Mylan Pharms Inc, Rising, Strides Pharma, Sun Pharm Inds Inc, Sun Pharm Inds Ltd, Sun Pharm Industries, Teva, Torrent Pharms, Watson Labs, Wockhardt, Yung Shin Pharm, Dr Reddys, Norvium Bioscience, and Novel Labs Inc, and is included in thirty-six NDAs. It is available from forty-four 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. Forty-six 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. Forty-six suppliers are listed for this compound. Additional details are available on the zolpidem tartrate profile page.
Summary for 204229
| Tradename: | ZOLPIDEM TARTRATE |
| Applicant: | Endo Operations |
| Ingredient: | zolpidem tartrate |
| Patents: | 0 |
Pharmacology for NDA: 204229
| Mechanism of Action | GABA A Receptor Positive Modulators |
| Physiological Effect | Central Nervous System Depression |
Suppliers and Packaging for NDA: 204229
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ZOLPIDEM TARTRATE | zolpidem tartrate | TABLET;SUBLINGUAL | 204229 | ANDA | ENDO USA, Inc. | 49884-898 | 49884-898-11 | 30 POUCH in 1 CARTON (49884-898-11) / 1 TABLET in 1 POUCH (49884-898-52) |
| ZOLPIDEM TARTRATE | zolpidem tartrate | TABLET;SUBLINGUAL | 204229 | ANDA | ENDO USA, Inc. | 49884-899 | 49884-899-11 | 30 POUCH in 1 CARTON (49884-899-11) / 1 TABLET in 1 POUCH (49884-899-52) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;SUBLINGUAL | Strength | 1.75MG | ||||
| Approval Date: | Sep 11, 2017 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;SUBLINGUAL | Strength | 3.5MG | ||||
| Approval Date: | Sep 11, 2017 | TE: | AB | RLD: | No | ||||
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