Details for New Drug Application (NDA): 071026
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NDA 071026 describes OXAZEPAM, which is a drug marketed by Actavis Elizabeth, Am Therap, Epic Pharma Llc, Ivax Sub Teva Pharms, Mylan, United Res Labs, Watson Labs, Watson Labs Teva, Parke Davis, and Sun Pharm Industries, and is included in twenty NDAs. It is available from four suppliers. Additional details are available on the OXAZEPAM profile page.
The generic ingredient in OXAZEPAM is oxazepam. There are eight drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the oxazepam profile page.
The generic ingredient in OXAZEPAM is oxazepam. There are eight drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the oxazepam profile page.
Summary for 071026
| Tradename: | OXAZEPAM |
| Applicant: | United Res Labs |
| Ingredient: | oxazepam |
| Patents: | 0 |
Suppliers and Packaging for NDA: 071026
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| OXAZEPAM | oxazepam | CAPSULE;ORAL | 071026 | ANDA | TruPharma, LLC | 52817-290 | 52817-290-10 | 100 CAPSULE in 1 BOTTLE (52817-290-10) |
| OXAZEPAM | oxazepam | CAPSULE;ORAL | 071026 | ANDA | TruPharma, LLC | 52817-291 | 52817-291-10 | 100 CAPSULE in 1 BOTTLE (52817-291-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 30MG | ||||
| Approval Date: | Aug 10, 1987 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 10MG | ||||
| Approval Date: | Aug 10, 1987 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 15MG | ||||
| Approval Date: | Aug 10, 1987 | TE: | AB | RLD: | No | ||||
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