Details for New Drug Application (NDA): 203482
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The generic ingredient in TEMAZEPAM is temazepam. There are seven drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the temazepam profile page.
Summary for 203482
Tradename: | TEMAZEPAM |
Applicant: | Amneal Pharms |
Ingredient: | temazepam |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 203482
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TEMAZEPAM | temazepam | CAPSULE;ORAL | 203482 | ANDA | Amneal Pharmaceuticals of New York LLC | 53746-556 | 53746-556-01 | 100 CAPSULE in 1 BOTTLE (53746-556-01) |
TEMAZEPAM | temazepam | CAPSULE;ORAL | 203482 | ANDA | Amneal Pharmaceuticals of New York LLC | 53746-556 | 53746-556-05 | 500 CAPSULE in 1 BOTTLE (53746-556-05) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 7.5MG | ||||
Approval Date: | May 23, 2016 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 15MG | ||||
Approval Date: | May 23, 2016 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 22.5MG | ||||
Approval Date: | May 23, 2016 | TE: | AB | RLD: | No |
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