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Details for New Drug Application (NDA): 021447
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NDA 021447 describes ZANAFLEX, which is a drug marketed by Covis Pharma Bv and is included in two NDAs. It is available from five 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-six 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-six suppliers are listed for this compound. Additional details are available on the tizanidine hydrochloride profile page.
Summary for 021447
| Tradename: | ZANAFLEX |
| Applicant: | Covis Pharma Bv |
| Ingredient: | tizanidine hydrochloride |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 021447
| Mechanism of Action | Adrenergic alpha2-Agonists |
Suppliers and Packaging for NDA: 021447
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ZANAFLEX | tizanidine hydrochloride | CAPSULE;ORAL | 021447 | NDA | Actavis Pharma, Inc. | 0591-2788 | 0591-2788-86 | 150 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (0591-2788-86) |
| ZANAFLEX | tizanidine hydrochloride | CAPSULE;ORAL | 021447 | NDA | Actavis Pharma, Inc. | 0591-2789 | 0591-2789-86 | 150 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (0591-2789-86) |
Paragraph IV (Patent) Challenges for 021447
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| ZANAFLEX | CAPSULE;ORAL | tizanidine hydrochloride | 021447 | 2007-08-10 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 2MG BASE | ||||
| Approval Date: | Aug 29, 2002 | TE: | AB | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 4MG BASE | ||||
| Approval Date: | Aug 29, 2002 | TE: | AB | RLD: | Yes | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 6MG BASE | ||||
| Approval Date: | Aug 29, 2002 | TE: | AB | RLD: | Yes | ||||
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