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Details for New Drug Application (NDA): 021447
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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