Application 090229
- Type
- ANDA
- Sponsor
- SYNTHON PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LEVOCETIRIZINE DIHYDROCHLORIDE | LEVOCETIRIZINE DIHYDROCHLORIDE | TABLET;ORAL | 5MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 45802-594 | levocetirizine dihydrochloride | levocetirizine dihydrochloride | Perrigo New York Inc | ANDA | Current |
| 63672-0051 | Levocetirizine dihydrochloride | Levocetirizine dihydrochloride | Synthon Pharmaceuticals, Inc. | ANDA | Current |
| 71205-204 | levocetirizine dihydrochloride | levocetirizine dihydrochloride | Proficient Rx LP | ANDA | Current |
| 71205-204 | levocetirizine dihydrochloride | levocetirizine dihydrochloride | Proficient Rx LP | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 31457 | ORIG | 2010-12-03 |