Application 077498
- Type
- ANDA
- Sponsor
- SUN PHARM INDS LTD
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 ALLERGY | CETIRIZINE HYDROCHLORIDE | TABLET;ORAL | 10MG | No | No |
| 003 | CETIRIZINE HYDROCHLORIDE HIVES | CETIRIZINE HYDROCHLORIDE | TABLET;ORAL | 5MG | No | No |
| 004 | CETIRIZINE HYDROCHLORIDE HIVES | 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 |
|---|
| 0904-6100 | Cetirizine hydrochloride | Cetirizine hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 10135-762 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | Marlex Pharmaceuticals, Inc | ANDA | Current |
| 10135-762 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | Marlex Pharmaceuticals, Inc | ANDA | Current |
| 10202-939 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | 7-ELEVEN | ANDA | Current |
| 15127-909 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | Select Brand | ANDA | Current |
| 36800-244 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | Topco Associates LLC | ANDA | Current |
| 37012-939 | Cetirizine Hydrochloride | Cetirizine | Shopko Stores Operating Co., LLC | ANDA | Current |
| 37205-820 | LEADER ALL DAY ALLERGY | cetirizine | Cardinal Health | ANDA | Current |
| 42254-138 | Cetirizine hydrochloride | Cetirizine hydrochloride | Rebel Distributors Corp | ANDA | Current |
| 49348-389 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | Sunmark | ANDA | Current |
| 50090-5518 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-5518 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 51660-939 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | Ohm Laboratories Inc. | ANDA | Current |
| 51660-939 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | Ohm Laboratories Inc. | ANDA | Current |
| 51660-939 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | Ohm Laboratories Inc. | ANDA | Current |
| 51660-939 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | Ohm Laboratories Inc. | ANDA | Current |
| 53329-652 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | Medline Industries, Inc. | ANDA | Current |
| 53329-652 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | Medline Industries, Inc. | ANDA | Current |
| 53329-652 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | Medline Industries, Inc. | ANDA | Current |
| 53329-652 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | Medline Industries, Inc. | ANDA | Current |
| 53329-652 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | Medline Industries, LP | ANDA | Current |
| 53329-652 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | Medline Industries, LP | ANDA | Current |
| 55289-995 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 55289-995 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 55289-995 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 55289-995 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 55289-995 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 55289-995 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 55289-995 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 55289-995 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 55301-939 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | Army & Air Force Exchange Service | ANDA | Current |
| 55319-939 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | FAMILY DOLLAR SERVICES, INC | ANDA | Current |
| 56062-939 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | Publix Super Markets Inc | ANDA | Current |
| 56062-939 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | Publix Super Markets Inc | ANDA | Current |
| 57451-5067 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | Ipca Laboratories Limited | ANDA | Current |
| 58593-827 | Zero Allergy | Cetirizine Hydrochloride | Efficient Laboratories Inc | ANDA | Current |
| 58593-827 | Zero Allergy | Cetirizine Hydrochloride | Efficient Laboratories Inc | ANDA | Current |
| 59779-939 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | CVS Pharmacy | ANDA | Current |
| 61715-062 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | Kinray | ANDA | Current |
| 63187-110 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | Proficient Rx LP | ANDA | Current |
| 63187-110 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | Proficient Rx LP | ANDA | Current |
| 63187-110 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | Proficient Rx LP | ANDA | Current |
| 63187-110 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | Proficient Rx LP | ANDA | Current |
| 63868-132 | Quality Choice Cetirizine Hydrochloride | Cetirizine Hydrochloride | Chain Drug Marketing Association Inc. | ANDA | Current |
| 63941-939 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | Valu Merchandisers Company | ANDA | Current |
| 67091-247 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | WinCo Foods, LLC | ANDA | Current |
| 68016-939 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | Chain Drug Consortium, LLC | ANDA | Current |
| 68071-2571 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68998-939 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | Marc Glassman, Inc. | ANDA | Current |
| 71141-133 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | LIDL US, LLC | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 31251 | ORIG | 2008-01-09 |
| 39533 | ORIG | 2008-01-08 |