Details for New Drug Application (NDA): 071175
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The generic ingredient in TEMAZEPAM is temazepam. There are seven drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the temazepam profile page.
Summary for 071175
Tradename: | TEMAZEPAM |
Applicant: | Sun Pharm Industries |
Ingredient: | temazepam |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 071175
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TEMAZEPAM | temazepam | CAPSULE;ORAL | 071175 | ANDA | Sun Pharmaceutical Industries, Inc. | 53489-649 | 53489-649-01 | 100 CAPSULE in 1 BOTTLE, PLASTIC (53489-649-01) |
TEMAZEPAM | temazepam | CAPSULE;ORAL | 071175 | ANDA | Sun Pharmaceutical Industries, Inc. | 53489-649 | 53489-649-03 | 250 CAPSULE in 1 BOTTLE, PLASTIC (53489-649-03) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | 30MG | ||||
Approval Date: | Jul 10, 1986 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | 22.5MG | ||||
Approval Date: | Sep 14, 2009 | TE: | RLD: | No |
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