FdaApplication
ANDA 212196
Identifiers
- fda_app_no: ANDA212196
Properties
| Property | Value |
|---|---|
| applicant_name | ALKEM LABORATORIES LTD |
| application_type | ANDA |
| approval_date | 2019-03-27 |
Products (3)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| TIZANIDINE HYDROCHLORIDE | TIZANIDINE HYDROCHLORIDE | EQ 2MG BASE | CAPSULE;ORAL |
| TIZANIDINE HYDROCHLORIDE | TIZANIDINE HYDROCHLORIDE | EQ 4MG BASE | CAPSULE;ORAL |
| TIZANIDINE HYDROCHLORIDE | TIZANIDINE HYDROCHLORIDE | EQ 6MG BASE | CAPSULE;ORAL |
3 products