Details for New Drug Application (NDA): 076286
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The generic ingredient in TIZANIDINE HYDROCHLORIDE is tizanidine hydrochloride. There are eleven drug master file entries for this compound. Fifty-two suppliers are listed for this compound. Additional details are available on the tizanidine hydrochloride profile page.
Summary for 076286
Tradename: | TIZANIDINE HYDROCHLORIDE |
Applicant: | Dr Reddys Labs Inc |
Ingredient: | tizanidine hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 076286
Mechanism of Action | Adrenergic alpha2-Agonists |
Suppliers and Packaging for NDA: 076286
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TIZANIDINE HYDROCHLORIDE | tizanidine hydrochloride | TABLET;ORAL | 076286 | ANDA | NorthStar Rx LLC | 16714-171 | 16714-171-01 | 150 TABLET in 1 BOTTLE (16714-171-01) |
TIZANIDINE HYDROCHLORIDE | tizanidine hydrochloride | TABLET;ORAL | 076286 | ANDA | NorthStar Rx LLC | 16714-172 | 16714-172-01 | 150 TABLET in 1 BOTTLE (16714-172-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 2MG BASE | ||||
Approval Date: | Jul 3, 2002 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 4MG BASE | ||||
Approval Date: | Jul 3, 2002 | TE: | AB | RLD: | No |
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