Details for New Drug Application (NDA): 076280
✉ Email this page to a colleague
The generic ingredient in TIZANIDINE HYDROCHLORIDE 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 076280
Tradename: | TIZANIDINE HYDROCHLORIDE |
Applicant: | Casi Pharms Inc |
Ingredient: | tizanidine hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 076280
Mechanism of Action | Adrenergic alpha2-Agonists |
Suppliers and Packaging for NDA: 076280
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TIZANIDINE HYDROCHLORIDE | tizanidine hydrochloride | TABLET;ORAL | 076280 | ANDA | Aphena Pharma Solutions - Tennessee, LLC | 71610-114 | 71610-114-30 | 30 TABLET in 1 BOTTLE (71610-114-30) |
TIZANIDINE HYDROCHLORIDE | tizanidine hydrochloride | TABLET;ORAL | 076280 | ANDA | Aphena Pharma Solutions - Tennessee, LLC | 71610-114 | 71610-114-53 | 60 TABLET in 1 BOTTLE (71610-114-53) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 2MG BASE | ||||
Approval Date: | Nov 26, 2002 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 4MG BASE | ||||
Approval Date: | Jun 27, 2002 | TE: | RLD: | No |
Complete Access Available with Subscription