Details for New Drug Application (NDA): 218920
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The generic ingredient in TIZANIDINE HYDROCHLORIDE 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 218920
Tradename: | TIZANIDINE HYDROCHLORIDE |
Applicant: | Graviti Pharms |
Ingredient: | tizanidine hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 218920
Mechanism of Action | Adrenergic alpha2-Agonists |
Suppliers and Packaging for NDA: 218920
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TIZANIDINE HYDROCHLORIDE | tizanidine hydrochloride | TABLET;ORAL | 218920 | ANDA | Graviti Pharmaceuticals Private Limited | 69844-107 | 69844-107-01 | 30 TABLET in 1 BOTTLE (69844-107-01) |
TIZANIDINE HYDROCHLORIDE | tizanidine hydrochloride | TABLET;ORAL | 218920 | ANDA | Graviti Pharmaceuticals Private Limited | 69844-107 | 69844-107-02 | 150 TABLET in 1 BOTTLE (69844-107-02) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 2MG BASE | ||||
Approval Date: | Aug 7, 2024 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 4MG BASE | ||||
Approval Date: | Aug 7, 2024 | TE: | AB | RLD: | No |
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