Details for New Drug Application (NDA): 213592
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NDA 213592 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-three 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-five 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-five suppliers are listed for this compound. Additional details are available on the zolpidem tartrate profile page.
Summary for 213592
| Tradename: | ZOLPIDEM TARTRATE |
| Applicant: | Breckenridge |
| Ingredient: | zolpidem tartrate |
| Patents: | 0 |
Pharmacology for NDA: 213592
| Mechanism of Action | GABA A Agonists GABA A Receptor Positive Modulators |
| Physiological Effect | Central Nervous System Depression |
Suppliers and Packaging for NDA: 213592
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ZOLPIDEM TARTRATE | zolpidem tartrate | TABLET, EXTENDED RELEASE;ORAL | 213592 | ANDA | Breckenridge Pharmaceutical, Inc. | 51991-981 | 51991-981-01 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (51991-981-01) |
| ZOLPIDEM TARTRATE | zolpidem tartrate | TABLET, EXTENDED RELEASE;ORAL | 213592 | ANDA | Breckenridge Pharmaceutical, Inc. | 51991-982 | 51991-982-01 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (51991-982-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 6.25MG | ||||
| Approval Date: | Jun 4, 2020 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 12.5MG | ||||
| Approval Date: | Jun 4, 2020 | TE: | RLD: | No | |||||
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