Application 079191
- Type
- ANDA
- Sponsor
- TORRENT PHARMS LLC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | TABLET;ORAL | 5MG | No | No |
| 002 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | TABLET;ORAL | 10MG | No | No |
| 003 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | TABLET;ORAL | 5MG | No | No |
| 004 | CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | TABLET;ORAL | 10MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 13668-030 | CETIRIZINE HYDROCHLORIDE | CETIRIZINE HYDROCHLORIDE | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-030 | CETIRIZINE HYDROCHLORIDE | CETIRIZINE HYDROCHLORIDE | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-590 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | Torrent Pharmaceuticals Limited | ANDA | Current |
| 13668-590 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | Torrent Pharmaceuticals Limited | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 9234 | ORIG | 2010-04-19 |