Details for New Drug Application (NDA): 213223
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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 213223
Tradename: | TIZANIDINE HYDROCHLORIDE |
Applicant: | Alembic |
Ingredient: | tizanidine hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 213223
Mechanism of Action | Adrenergic alpha2-Agonists |
Suppliers and Packaging for NDA: 213223
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TIZANIDINE HYDROCHLORIDE | tizanidine hydrochloride | CAPSULE;ORAL | 213223 | ANDA | Alembic Pharmaceuticals Limited | 46708-491 | 46708-491-08 | 80 BLISTER PACK in 1 CARTON (46708-491-08) / 8 CAPSULE in 1 BLISTER PACK |
TIZANIDINE HYDROCHLORIDE | tizanidine hydrochloride | CAPSULE;ORAL | 213223 | ANDA | Alembic Pharmaceuticals Limited | 46708-491 | 46708-491-30 | 30 CAPSULE in 1 BOTTLE (46708-491-30) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 2MG BASE | ||||
Approval Date: | Jan 13, 2020 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 4MG BASE | ||||
Approval Date: | Jan 13, 2020 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 6MG BASE | ||||
Approval Date: | Jan 13, 2020 | TE: | AB | RLD: | No |
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