Application 090300
- Type
- ANDA
- Sponsor
- CYPRESS PHARM
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | SYRUP;ORAL | 5MG/5ML | No | No |
| 002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | SYRUP;ORAL | 5MG/5ML | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0121-4780 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | Pharmaceutical Associates, Inc. | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 31461 | ORIG | 2008-10-22 |