Details for New Drug Application (NDA): 213798
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The generic ingredient in TIZANIDINE HYDROCHLORIDE is tizanidine hydrochloride. There are eleven drug master file entries for this compound. Fifty-five suppliers are listed for this compound. Additional details are available on the tizanidine hydrochloride profile page.
Summary for 213798
Tradename: | TIZANIDINE HYDROCHLORIDE |
Applicant: | Rubicon |
Ingredient: | tizanidine hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 213798
Mechanism of Action | Adrenergic alpha2-Agonists |
Suppliers and Packaging for NDA: 213798
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TIZANIDINE HYDROCHLORIDE | tizanidine hydrochloride | CAPSULE;ORAL | 213798 | ANDA | Preferred Pharmaceuticals Inc. | 68788-8776 | 68788-8776-1 | 100 CAPSULE in 1 BOTTLE (68788-8776-1) |
TIZANIDINE HYDROCHLORIDE | tizanidine hydrochloride | CAPSULE;ORAL | 213798 | ANDA | Preferred Pharmaceuticals Inc. | 68788-8776 | 68788-8776-2 | 20 CAPSULE in 1 BOTTLE (68788-8776-2) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 2MG BASE | ||||
Approval Date: | May 27, 2020 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 4MG BASE | ||||
Approval Date: | May 27, 2020 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 6MG BASE | ||||
Approval Date: | May 27, 2020 | TE: | AB | RLD: | No |
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