Details for New Drug Application (NDA): 217875
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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 217875
Tradename: | TEMAZEPAM |
Applicant: | Alkem Labs Ltd |
Ingredient: | temazepam |
Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 217875
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 7.5MG | ||||
Approval Date: | Aug 24, 2023 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 15MG | ||||
Approval Date: | Aug 24, 2023 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 22.5MG | ||||
Approval Date: | Aug 24, 2023 | TE: | AB | RLD: | No |
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