Application 202915
- Type
- ANDA
- Sponsor
- APOTEX
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LEVOCETIRIZINE DIHYDROCHLORIDE | LEVOCETIRIZINE DIHYDROCHLORIDE | SOLUTION;ORAL | 2.5MG/5ML | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 60505-0403 | LEVOCETIRIZINE DIHYDROCHLORIDE | LEVOCETIRIZINE DIHYDROCHLORIDE | Apotex Corp. | ANDA | Current |
| 60505-0403 | LEVOCETIRIZINE DIHYDROCHLORIDE | LEVOCETIRIZINE DIHYDROCHLORIDE | Apotex Corp. | ANDA | Current |
| 60505-0403 | LEVOCETIRIZINE DIHYDROCHLORIDE | LEVOCETIRIZINE DIHYDROCHLORIDE | Apotex Corp. | ANDA | Current |