Details for New Drug Application (NDA): 201781
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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 201781
Tradename: | TEMAZEPAM |
Applicant: | Prinston Inc |
Ingredient: | temazepam |
Patents: | 0 |
Suppliers and Packaging for NDA: 201781
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TEMAZEPAM | temazepam | CAPSULE;ORAL | 201781 | ANDA | Solco Healthcare U.S., LLC | 43547-611 | 43547-611-10 | 100 CAPSULE in 1 BOTTLE, PLASTIC (43547-611-10) |
TEMAZEPAM | temazepam | CAPSULE;ORAL | 201781 | ANDA | Solco Healthcare U.S., LLC | 43547-612 | 43547-612-10 | 100 CAPSULE in 1 BOTTLE, PLASTIC (43547-612-10) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 7.5MG | ||||
Approval Date: | Jun 4, 2015 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 15MG | ||||
Approval Date: | Jun 4, 2015 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 22.5MG | ||||
Approval Date: | Jun 4, 2015 | TE: | AB | RLD: | No |
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