Details for New Drug Application (NDA): 020397
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The generic ingredient in ZANAFLEX is tizanidine hydrochloride. There are eleven drug master file entries for this compound. Fifty-two suppliers are listed for this compound. Additional details are available on the tizanidine hydrochloride profile page.
Summary for 020397
Tradename: | ZANAFLEX |
Applicant: | Legacy Pharma Usa |
Ingredient: | tizanidine hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 020397
Mechanism of Action | Adrenergic alpha2-Agonists |
Suppliers and Packaging for NDA: 020397
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ZANAFLEX | tizanidine hydrochloride | TABLET;ORAL | 020397 | NDA | Covis Pharma US, Inc | 70515-594 | 70515-594-15 | 150 TABLET in 1 BOTTLE (70515-594-15) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 4MG BASE | ||||
Approval Date: | Nov 27, 1996 | TE: | AB | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Feb 4, 2000 | TE: | RLD: | Yes |
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