Application 213544
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | TIZANIDINE HYDROCHLORIDE | TIZANIDINE HYDROCHLORIDE | CAPSULE;ORAL | EQ 2MG BASE | No | No |
| 002 | TIZANIDINE HYDROCHLORIDE | TIZANIDINE HYDROCHLORIDE | CAPSULE;ORAL | EQ 4MG BASE | No | No |
| 003 | TIZANIDINE HYDROCHLORIDE | TIZANIDINE HYDROCHLORIDE | CAPSULE;ORAL | EQ 6MG BASE | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 59651-314 | Tizanidine Hydrochloride | Tizanidine Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 59651-314 | Tizanidine Hydrochloride | Tizanidine Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 59651-314 | Tizanidine Hydrochloride | Tizanidine Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 59651-315 | Tizanidine Hydrochloride | Tizanidine Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 59651-315 | Tizanidine Hydrochloride | Tizanidine Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 59651-315 | Tizanidine Hydrochloride | Tizanidine Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 59651-316 | Tizanidine Hydrochloride | Tizanidine Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 59651-316 | Tizanidine Hydrochloride | Tizanidine Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 59651-316 | Tizanidine Hydrochloride | Tizanidine Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |