Details for New Drug Application (NDA): 021447
✉ Email this page to a colleague
The generic ingredient in ZANAFLEX is tizanidine hydrochloride. There are eleven drug master file entries for this compound. Fifty-three suppliers are listed for this compound. Additional details are available on the tizanidine hydrochloride profile page.
Summary for 021447
Tradename: | ZANAFLEX |
Applicant: | Legacy Pharma Usa |
Ingredient: | tizanidine hydrochloride |
Patents: | 0 |
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 AUTHORIZED GENERIC | 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 AUTHORIZED GENERIC | Actavis Pharma, Inc. | 0591-2789 | 0591-2789-86 | 150 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (0591-2789-86) |
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 |
Expired US Patents for NDA 021447
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Legacy Pharma Usa | ZANAFLEX | tizanidine hydrochloride | CAPSULE;ORAL | 021447-001 | Aug 29, 2002 | ⤷ Sign Up | ⤷ Sign Up |
Legacy Pharma Usa | ZANAFLEX | tizanidine hydrochloride | CAPSULE;ORAL | 021447-003 | Aug 29, 2002 | ⤷ Sign Up | ⤷ Sign Up |
Legacy Pharma Usa | ZANAFLEX | tizanidine hydrochloride | CAPSULE;ORAL | 021447-002 | Aug 29, 2002 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Complete Access Available with Subscription