Details for New Drug Application (NDA): 020397
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NDA 020397 describes ZANAFLEX, which is a drug marketed by Legacy Pharma Usa and is included in two NDAs. It is available from two suppliers. Additional details are available on the ZANAFLEX profile page.
The generic ingredient in ZANAFLEX is tizanidine hydrochloride. There are eleven drug master file entries for this compound. Forty-eight suppliers are listed for this compound. Additional details are available on the tizanidine hydrochloride profile page.
The generic ingredient in ZANAFLEX is tizanidine hydrochloride. There are eleven drug master file entries for this compound. Forty-eight 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 |
| Formulation / Manufacturing: | see details |
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| Dosage: | TABLET;ORAL | Strength | EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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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