Details for New Drug Application (NDA): 078868
✉ Email this page to a colleague
NDA 078868 describes TIZANIDINE HYDROCHLORIDE, which is a drug marketed by Alembic, Alkem Labs Ltd, Apotex Inc, Aurobindo Pharma Ltd, Cadila Pharms Ltd, Ingenus Pharms Llc, Jubilant Generics, Ph Health, Pharmobedient, Rubicon Research, Senores Pharms, Zydus Pharms, Ani Pharms, Apotex, Aurobindo Pharma Usa, Cadila, Chartwell Rx, Dr Reddys Labs Inc, Epic Pharma Llc, Oxford Pharms, Rising, Sun Pharm Inds Inc, and Unichem Labs Ltd, and is included in twenty-nine NDAs. It is available from forty-nine suppliers. Additional details are available on the TIZANIDINE HYDROCHLORIDE profile page.
The generic ingredient in TIZANIDINE HYDROCHLORIDE is tizanidine hydrochloride. There is one drug master file entry for this compound. Fifty-three 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 is one drug master file entry for this compound. Fifty-three suppliers are listed for this compound. Additional details are available on the tizanidine hydrochloride profile page.
Summary for 078868
| Tradename: | TIZANIDINE HYDROCHLORIDE |
| Applicant: | Apotex Inc |
| Ingredient: | tizanidine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 078868
| Mechanism of Action | Adrenergic alpha2-Agonists |
Suppliers and Packaging for NDA: 078868
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TIZANIDINE HYDROCHLORIDE | tizanidine hydrochloride | CAPSULE;ORAL | 078868 | ANDA | AvKARE | 42291-811 | 42291-811-15 | 150 CAPSULE, GELATIN COATED in 1 BOTTLE (42291-811-15) |
| TIZANIDINE HYDROCHLORIDE | tizanidine hydrochloride | CAPSULE;ORAL | 078868 | ANDA | Apotex Corp. | 60505-2648 | 60505-2648-3 | 30 CAPSULE, GELATIN COATED in 1 BOTTLE (60505-2648-3) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 2MG BASE | ||||
| Approval Date: | Feb 3, 2012 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 4MG BASE | ||||
| Approval Date: | Feb 3, 2012 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 6MG BASE | ||||
| Approval Date: | Feb 3, 2012 | TE: | AB | RLD: | No | ||||
Complete Access Available with Subscription
