Details for New Drug Application (NDA): 213798
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NDA 213798 describes TIZANIDINE HYDROCHLORIDE, which is a drug marketed by Alembic, Alkem Labs Ltd, Apotex Inc, Aurobindo Pharma Ltd, Cadila Pharms Ltd, Endo Operations, Jubilant Generics, Norvium Bioscience, Novast Labs, Rubicon, Somerset Theraps Llc, Zydus Pharms, Ani Pharms, Apotex, Aurobindo Pharma Usa, Cadila, Chartwell Rx, Dr Reddys Labs Inc, Epic Pharma Llc, Graviti Pharms, Oxford Pharms, Rising, Sun Pharm Inds Inc, and Unichem Labs Ltd, and is included in twenty-nine NDAs. It is available from fifty suppliers. Additional details are available on the TIZANIDINE HYDROCHLORIDE profile page.
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.
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 213798
| Tradename: | TIZANIDINE HYDROCHLORIDE |
| Applicant: | Rubicon |
| Ingredient: | tizanidine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 213798
| Mechanism of Action | Adrenergic alpha2-Agonists |
Suppliers and Packaging for NDA: 213798
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TIZANIDINE HYDROCHLORIDE | tizanidine hydrochloride | CAPSULE;ORAL | 213798 | ANDA | Advagen Pharma Limited | 72888-001 | 72888-001-15 | 150 CAPSULE in 1 BOTTLE (72888-001-15) |
| TIZANIDINE HYDROCHLORIDE | tizanidine hydrochloride | CAPSULE;ORAL | 213798 | ANDA | Advagen Pharma Limited | 72888-002 | 72888-002-15 | 150 CAPSULE in 1 BOTTLE (72888-002-15) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 2MG BASE | ||||
| Approval Date: | May 27, 2020 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 4MG BASE | ||||
| Approval Date: | May 27, 2020 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 6MG BASE | ||||
| Approval Date: | May 27, 2020 | TE: | AB | RLD: | No | ||||
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