Details for New Drug Application (NDA): 078868
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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 078868
Tradename: | TIZANIDINE HYDROCHLORIDE |
Applicant: | Apotex Inc |
Ingredient: | tizanidine hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 078868
Mechanism of Action | Adrenergic alpha2-Agonists |
Suppliers and Packaging for NDA: 078868
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TIZANIDINE HYDROCHLORIDE | tizanidine hydrochloride | CAPSULE;ORAL | 078868 | ANDA | AvKARE | 42291-811 | 42291-811-15 | 150 CAPSULE, GELATIN COATED in 1 BOTTLE (42291-811-15) |
TIZANIDINE HYDROCHLORIDE | tizanidine hydrochloride | CAPSULE;ORAL | 078868 | ANDA | medsource pharmaceuticals | 45865-954 | 45865-954-30 | 30 CAPSULE, GELATIN COATED in 1 BOTTLE (45865-954-30) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 2MG BASE | ||||
Approval Date: | Feb 3, 2012 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 4MG BASE | ||||
Approval Date: | Feb 3, 2012 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 6MG BASE | ||||
Approval Date: | Feb 3, 2012 | TE: | AB | RLD: | No |
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