Details for New Drug Application (NDA): 071026
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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.
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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