Application 090191
- Type
- ANDA
- Sponsor
- MLV
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CETIRIZINE HYDROCHLORIDE | CETIRIZINE HYDROCHLORIDE | SYRUP;ORAL | 5MG/5ML | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 57664-181 | cetirizine hydrochloride | cetirizine hydrochloride | Caraco Pharmaceutical Laboratories, Ltd. | ANDA | Current |