Application 078243
- Type
- ANDA
- Sponsor
- ZYDUS PHARMS USA INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | TABLET;ORAL | 25MG | No | No |
| 002 | LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | TABLET;ORAL | 50MG | No | No |
| 003 | LOSARTAN POTASSIUM | LOSARTAN POTASSIUM | TABLET;ORAL | 100MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0615-7958 | Losartan Potassium | Losartan Potassium | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-7958 | Losortan Potassium | Losartan Potassium | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-7959 | Losartan Potassium | Losartan Potassium | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-7959 | Losortan Potassium | Losartan Potassium | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-7960 | Losartan Potassium | Losartan Potassium | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-7960 | Losortan Potassium | Losartan Potassium | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0904-7047 | Losartan Potassium | Losartan Potassium | Major Pharmaceuticals | ANDA | Current |
| 0904-7047 | Losartan Potassium | Losartan Potassium | Major Pharmaceuticals | ANDA | Current |
| 0904-7047 | Losartan Potassium | Losartan Potassium | Major Pharmaceuticals | ANDA | Current |
| 0904-7048 | Losartan Potassium | Losartan Potassium | Major Pharmaceuticals | ANDA | Current |
| 0904-7048 | Losartan Potassium | Losartan Potassium | Major Pharmaceuticals | ANDA | Current |
| 0904-7048 | Losartan Potassium | Losartan Potassium | Major Pharmaceuticals | ANDA | Current |
| 0904-7049 | Losartan Potassium | Losartan Potassium | Major Pharmaceuticals | ANDA | Current |
| 0904-7049 | Losartan Potassium | Losartan Potassium | Major Pharmaceuticals | ANDA | Current |
| 0904-7049 | Losartan Potassium | Losartan Potassium | Major Pharmaceuticals | ANDA | Current |
| 21695-714 | Losortan Potassium | Losartan Potassium | Rebel Distributors Corp | ANDA | Current |
| 21695-717 | Losortan Potassium | Losartan Potassium | Rebel Distributors Corp | ANDA | Current |
| 21695-989 | Losortan Potassium | Losartan Potassium | Rebel Distributors Corp | ANDA | Current |
| 33261-818 | Losortan Potassium | Losartan Potassium | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 33261-819 | Losortan Potassium | Losartan Potassium | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 33261-996 | Losortan Potassium | Losartan Potassium | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 43063-347 | Losortan Potassium | Losartan Potassium | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-347 | Losortan Potassium | Losartan Potassium | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-347 | Losortan Potassium | Losartan Potassium | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-347 | Losortan Potassium | Losartan Potassium | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 45865-684 | Losortan Potassium | Losartan Potassium | Medsource Pharmaceuticals | ANDA | Current |
| 50268-504 | Losortan Potassium | Losartan Potassium | AvPAK | ANDA | Current |
| 50268-504 | Losortan Potassium | Losartan Potassium | AvPAK | ANDA | Current |
| 50268-504 | Losortan Potassium | Losartan Potassium | AvPAK | ANDA | Current |
| 50268-505 | Losortan Potassium | Losartan Potassium | AvPAK | ANDA | Current |
| 50268-505 | Losortan Potassium | Losartan Potassium | AvPAK | ANDA | Current |
| 50268-505 | Losortan Potassium | Losartan Potassium | AvPAK | ANDA | Current |
| 50268-506 | Losortan Potassium | Losartan Potassium | AvPAK | ANDA | Current |
| 50268-506 | Losortan Potassium | Losartan Potassium | AvPAK | ANDA | Current |
| 50268-506 | Losortan Potassium | Losartan Potassium | AvPAK | ANDA | Current |
| 53808-1072 | Losortan Potassium | Losartan Potassium | State of Florida DOH Central Pharmacy | ANDA | Current |
| 55154-2089 | Losartan Potassium | Losartan Potassium | Cardinal Health | ANDA | Current |
| 55154-2089 | Losartan Potassium | Losartan Potassium | Cardinal Health | ANDA | Current |
| 55154-2089 | Losartan Potassium | Losartan Potassium | Cardinal Health 107, LLC | ANDA | Current |
| 55154-2089 | Losartan Potassium | Losartan Potassium | Cardinal Health | ANDA | Current |
| 55154-2326 | Losartan Potassium | Losartan Potassium | Cardinal Health | ANDA | Current |
| 55154-2326 | Losartan Potassium | Losartan Potassium | Cardinal Health | ANDA | Current |
| 55154-2326 | Losartan Potassium | Losartan Potassium | Cardinal Health | ANDA | Current |
| 55154-2326 | Losartan Potassium | Losartan Potassium | Cardinal Health | ANDA | Current |
| 55154-2326 | Losartan Potassium | Losartan Potassium | Cardinal Health | ANDA | Current |
| 55154-2326 | Losartan Potassium | Losartan Potassium | Cardinal Health | ANDA | Current |
| 55154-2327 | Losartan Potassium | Losartan Potassium | Cardinal Health | ANDA | Current |
| 55154-2327 | Losartan Potassium | Losartan Potassium | Cardinal Health | ANDA | Current |
| 55154-2327 | Losartan Potassium | Losartan Potassium | Cardinal Health | ANDA | Current |
| 55154-2327 | Losartan Potassium | Losartan Potassium | Cardinal Health | ANDA | Current |
| 55154-2327 | Losartan Potassium | Losartan Potassium | Cardinal Health | ANDA | Current |
| 55154-2327 | Losartan Potassium | Losartan Potassium | Cardinal Health | ANDA | Current |
| 55154-2333 | Losartan Potassium | Losartan Potassium | Cardinal Health | ANDA | Current |
| 55154-2333 | Losartan Potassium | Losartan Potassium | Cardinal Health | ANDA | Current |
| 55154-2333 | Losartan Potassium | Losartan Potassium | Cardinal Health | ANDA | Current |
| 55154-2333 | Losartan Potassium | Losartan Potassium | Cardinal Health | ANDA | Current |
| 55154-2333 | Losartan Potassium | Losartan Potassium | Cardinal Health | ANDA | Current |
| 55154-4783 | Losartan Potassium | Losartan Potassium | Cardinal Health | ANDA | Current |
| 55154-4783 | Losartan Potassium | Losartan Potassium | Cardinal Health | ANDA | Current |
| 55154-4783 | Losartan Potassium | Losartan Potassium | Cardinal Health 107, LLC | ANDA | Current |
| 55154-4783 | Losartan Potassium | Losartan Potassium | Cardinal Health | ANDA | Current |
| 55154-6643 | Losartan Potassium | Losartan Potassium | Cardinal Health | ANDA | Current |
| 55154-6643 | Losartan Potassium | Losartan Potassium | Cardinal Health | ANDA | Current |
| 55154-6643 | Losartan Potassium | Losartan Potassium | Cardinal Health 107, LLC | ANDA | Current |
| 55154-6643 | Losartan Potassium | Losartan Potassium | Cardinal Health | ANDA | Current |
| 58517-240 | Losartan Potatssium | Losartan Potatssium | New Horizon Rx Group, LLC | ANDA | Current |
| 63187-071 | Losortan Potassium | Losartan Potassium | Proficient Rx LP | ANDA | Current |
| 63187-071 | Losortan Potassium | Losartan Potassium | Proficient Rx LP | ANDA | Current |
| 63187-072 | Losortan Potassium | Losartan Potassium | Proficient Rx LP | ANDA | Current |
| 63187-072 | Losortan Potassium | Losartan Potassium | Proficient Rx LP | ANDA | Current |
| 63629-4238 | Losortan Potassium | Losartan Potassium | Bryant Ranch Prepack | ANDA | Current |
| 63629-4238 | Losortan Potassium | Losartan Potassium | Bryant Ranch Prepack | ANDA | Current |
| 63739-673 | Losortan Potassium | Losartan Potassium | McKesson Corporation dba SKY Packaging | ANDA | Current |
| 63739-673 | Losortan Potassium | Losartan Potassium | Mckesson Corporation DBA SKY Packaginng | ANDA | Current |
| 63739-673 | Losortan Potassium | Losartan Potassium | McKesson Corporation | ANDA | Current |
| 63739-673 | Losortan Potassium | Losartan Potassium | Mckesson Corporation DBA SKY Packaginng | ANDA | Current |
| 63739-673 | Losortan Potassium | Losartan Potassium | Mckesson Corporation DBA SKY Packaginng | ANDA | Current |
| 63739-673 | Losortan Potassium | Losartan Potassium | Mckesson Corporation DBA SKY Packaginng | ANDA | Current |
| 63739-686 | Losortan Potassium | Losartan Potassium | McKesson Corporation dba SKY Packaging | ANDA | Current |
| 63739-686 | Losartan Potassium | Losartan Potassium | Mckesson Corporation DBA SKY Packaginng | ANDA | Current |