Details for New Drug Application (NDA): 218920
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NDA 218920 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 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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