Application 078343
- Type
- ANDA
- Sponsor
- DR REDDYS LABS LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | CETIRIZINE HYDROCHLORIDE HIVES | CETIRIZINE HYDROCHLORIDE | TABLET;ORAL | 5MG | No | No |
| 002 | CETIRIZINE HYDROCHLORIDE HIVES | CETIRIZINE HYDROCHLORIDE | TABLET;ORAL | 10MG | No | No |
| 003 | CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | TABLET;ORAL | 10MG | No | No |
| 004 | CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | TABLET;ORAL | 5MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 43598-811 | Cetirizine Hydrochloride | Cetirizine Hydrochloride Tablets | Dr. Reddy's Laboratories Inc. | ANDA | Current |
| 43598-811 | Cetirizine Hydrochloride | Cetirizine Hydrochloride Tablets | Dr. Reddy's Laboratories Inc. | ANDA | Current |
| 43598-811 | Cetirizine Hydrochloride | Cetirizine Hydrochloride Tablets | Dr. Reddy's Laboratories Inc. | ANDA | Current |
| 49035-010 | Allergy Relief | Cetirizine Hydrochloride Tablets | Wal-Mart Stores Inc | ANDA | Current |
| 53943-519 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | Discount Drug Mart, Inc | ANDA | Current |
| 55111-351 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | Dr.Reddy's Laboratories Limited | ANDA | Current |
| 55111-699 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | Dr.Reddy's Laboratories Limited | ANDA | Current |
| 62011-0307 | cetirizine hydrochloride | Cetirizine Hydrochloride Tablets | Strategic Sourcing Services LLC | ANDA | Current |
| 62011-0307 | cetirizine hydrochloride | Cetirizine Hydrochloride Tablets | MCKESSON | ANDA | Current |
| 62011-0307 | cetirizine hydrochloride | Cetirizine Hydrochloride Tablets | Strategic Sourcing Services LLC | ANDA | Current |
| 62011-0307 | cetirizine hydrochloride | Cetirizine Hydrochloride Tablets | Strategic Sourcing Services LLC | ANDA | Current |
| 62011-0414 | cetirizine hydrochloride | Cetirizine Hydrochloride Tablets | Strategic Sourcing Services LLC | ANDA | Current |
| 62011-0414 | cetirizine hydrochloride | Cetirizine Hydrochloride Tablets | Strategic Sourcing Services LLC | ANDA | Current |
| 62011-0414 | cetirizine hydrochloride | Cetirizine Hydrochloride Tablets | Strategic Sourcing Services LLC | ANDA | Current |
| 68071-2570 | Cetirizine Hydrochloride | Cetirizine Hydrochloride Tablets | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 69842-867 | Allergy Relief | Cetirizine Hydrochloride Tablets | CVS Health Corp. | ANDA | Current |
| 70518-3468 | Cetirizine Hydrochloride | Cetirizine Hydrochloride Tablets | REMEDYREPACK INC. | ANDA | Current |
| 70518-3468 | Cetirizine Hydrochloride | Cetirizine Hydrochloride Tablets | REMEDYREPACK INC. | ANDA | Current |
| 70518-3468 | Cetirizine Hydrochloride | Cetirizine Hydrochloride Tablets | REMEDYREPACK INC. | ANDA | Current |
| 70518-3468 | Cetirizine Hydrochloride | Cetirizine Hydrochloride Tablets | REMEDYREPACK INC. | ANDA | Current |
| 70677-0142 | cetirizine hydrochloride | Cetirizine Hydrochloride Tablets | Strategic Sourcing Services LLC | ANDA | Current |
| 70677-0142 | cetirizine hydrochloride | Cetirizine Hydrochloride Tablets | Strategic Sourcing Services LLC | ANDA | Current |
| 71205-709 | Cetirizine Hydrochloride | Cetirizine Hydrochloride Tablets | Proficient Rx LP | ANDA | Current |
| 71335-9612 | Cetirizine Hydrochloride | Cetirizine Hydrochloride Tablets | Bryant Ranch Prepack | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 39557 | ORIG | 2008-01-23 |
| 31358 | ORIG | 2008-01-17 |