Details for New Drug Application (NDA): 213365
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The generic ingredient in TIZANIDINE HYDROCHLORIDE is tizanidine hydrochloride. There are eleven drug master file entries for this compound. Fifty-three suppliers are listed for this compound. Additional details are available on the tizanidine hydrochloride profile page.
Summary for 213365
Tradename: | TIZANIDINE HYDROCHLORIDE |
Applicant: | Somerset Theraps Llc |
Ingredient: | tizanidine hydrochloride |
Patents: | 0 |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 4MG BASE | ||||
Approval Date: | May 13, 2024 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 6MG BASE | ||||
Approval Date: | May 13, 2024 | TE: | AB | RLD: | No |
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