Application 091269
- Type
- ANDA
- Sponsor
- DR REDDYS LABS LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | LANSOPRAZOLE | LANSOPRAZOLE | CAPSULE, DELAYED REL PELLETS;ORAL | 15MG | No | No |
| 002 | LANSOPRAZOLE | LANSOPRAZOLE | CAPSULE, DELAYED REL PELLETS;ORAL | 30MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0904-6662 | Lansoprazole | lansoprazole | Major Pharmaceuticals | ANDA | Current |
| 0904-6662 | Lansoprazole | lansoprazole | Major Pharmaceuticals | ANDA | Current |
| 0904-6662 | Lansoprazole | lansoprazole | Major Pharmaceuticals | ANDA | Current |
| 33261-674 | Lansoprazole | lansoprazole | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 42254-331 | Lansoprazole | lansoprazole | Rebel Distributors Corp | ANDA | Current |
| 45865-879 | Lansoprazole | lansoprazole | medsource pharmaceuticals | ANDA | Current |
| 52959-352 | LANSOPRAZOLE | LANSOPRAZOLE | H.J. Harkins Co., Inc | ANDA | Current |
| 55111-398 | Lansoprazole | lansoprazole | Dr.Reddy's Laboratories Ltd. | ANDA | Current |
| 55111-398 | Lansoprazole | lansoprazole | Dr.Reddy's Laboratories Ltd. | ANDA | Current |
| 55111-398 | Lansoprazole | lansoprazole | Dr.Reddy's Laboratories Ltd. | ANDA | Current |
| 55111-398 | Lansoprazole | lansoprazole | Dr.Reddy's Laboratories Ltd. | ANDA | Current |
| 55111-399 | Lansoprazole | lansoprazole | Dr.Reddy's Laboratories Ltd. | ANDA | Current |
| 55111-399 | Lansoprazole | lansoprazole | Dr.Reddy's Laboratories Ltd. | ANDA | Current |
| 55111-399 | Lansoprazole | lansoprazole | Dr.Reddy's Laboratories Ltd. | ANDA | Current |
| 55111-399 | Lansoprazole | lansoprazole | Dr.Reddy's Laboratories Ltd. | ANDA | Current |
| 55700-595 | Lansoprazole | lansoprazole | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 60687-111 | Lansoprazole | lansoprazole | American Health Packaging | ANDA | Current |
| 60687-111 | Lansoprazole | lansoprazole | American Health Packaging | ANDA | Current |
| 60687-111 | Lansoprazole | lansoprazole | American Health Packaging | ANDA | Current |
| 60687-111 | Lansoprazole | lansoprazole | American Health Packaging | ANDA | Current |
| 60687-111 | Lansoprazole | lansoprazole | American Health Packaging | ANDA | Current |
| 60687-123 | Lansoprazole | lansoprazole | American Health Packaging | ANDA | Current |
| 60687-123 | Lansoprazole | lansoprazole | American Health Packaging | ANDA | Current |
| 60687-123 | Lansoprazole | lansoprazole | American Health Packaging | ANDA | Current |
| 60687-123 | Lansoprazole | lansoprazole | American Health Packaging | ANDA | Current |
| 60687-123 | Lansoprazole | lansoprazole | American Health Packaging | ANDA | Current |
| 61919-245 | LANSOPRAZOLE | LANSOPRAZOLE | DIRECT RX | ANDA | Current |
| 61919-245 | LANSOPRAZOLE | LANSOPRAZOLE | DIRECT RX | ANDA | Current |
| 63187-510 | Lansoprazole | lansoprazole | Proficient Rx LP | ANDA | Current |
| 63187-510 | Lansoprazole | lansoprazole | Proficient Rx LP | ANDA | Current |
| 63187-510 | Lansoprazole | lansoprazole | Proficient Rx LP | ANDA | Current |
| 63187-510 | Lansoprazole | lansoprazole | Proficient Rx LP | ANDA | Current |
| 63739-555 | Lansoprazole | lansoprazole | McKesson Corporation | ANDA | Current |
| 63739-555 | Lansoprazole | lansoprazole | McKesson Corporation dba SKY Packaging | ANDA | Current |
| 63739-555 | Lansoprazole | lansoprazole | McKesson Corporation dba SKY Packaging | ANDA | Current |
| 63739-555 | Lansoprazole | lansoprazole | McKesson Corporation dba SKY Packaging | ANDA | Current |
| 63739-574 | Lansoprazole | lansoprazole | McKesson Corporation | ANDA | Current |
| 63739-574 | Lansoprazole | lansoprazole | McKesson Corporation dba SKY Packaging | ANDA | Current |
| 68001-111 | Lansoprazole | lansoprazole | BluePoint Laboratories | ANDA | Current |
| 68001-111 | Lansoprazole | lansoprazole | BluePoint Laboratories | ANDA | Current |
| 68001-111 | Lansoprazole | lansoprazole | BluePoint Laboratories | ANDA | Current |
| 68001-111 | Lansoprazole | lansoprazole | BluePoint Laboratories | ANDA | Current |
| 68001-111 | Lansoprazole | lansoprazole | BluePoint Laboratories | ANDA | Current |
| 68001-111 | Lansoprazole | lansoprazole | BluePoint Laboratories | ANDA | Current |
| 68001-112 | Lansoprazole | lansoprazole | BluePoint Laboratories | ANDA | Current |
| 68001-112 | Lansoprazole | lansoprazole | BluePoint Laboratories | ANDA | Current |
| 68001-112 | Lansoprazole | lansoprazole | BluePoint Laboratories | ANDA | Current |
| 68001-112 | Lansoprazole | lansoprazole | BluePoint Laboratories | ANDA | Current |
| 68001-112 | Lansoprazole | lansoprazole | BluePoint Laboratories | ANDA | Current |
| 68001-112 | Lansoprazole | lansoprazole | BluePoint Laboratories | ANDA | Current |
| 68071-1972 | Lansoprazole | lansoprazole | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68071-4456 | Lansoprazole | lansoprazole | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4456 | Lansoprazole | lansoprazole | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4456 | Lansoprazole | lansoprazole | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68788-6390 | Lansoprazole | lansoprazole | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-6390 | Lansoprazole | lansoprazole | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-6390 | Lansoprazole | lansoprazole | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-6390 | Lansoprazole | lansoprazole | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-6390 | Lansoprazole | lansoprazole | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-9281 | Lansoprazole | lansoprazole | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-9281 | Lansoprazole | lansoprazole | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-9281 | Lansoprazole | lansoprazole | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 70934-423 | Lansoprazole | lansoprazole | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 71335-0043 | Lansoprazole | lansoprazole | Bryant Ranch Prepack | ANDA | Current |
| 71335-0043 | Lansoprazole | lansoprazole | Bryant Ranch Prepack | ANDA | Current |
| 71335-0043 | Lansoprazole | lansoprazole | Bryant Ranch Prepack | ANDA | Current |
| 71335-0043 | Lansoprazole | lansoprazole | Bryant Ranch Prepack | ANDA | Current |
| 71335-0058 | Lansoprazole | lansoprazole | Bryant Ranch Prepack | ANDA | Current |
| 71335-0058 | Lansoprazole | lansoprazole | Bryant Ranch Prepack | ANDA | Current |
| 71335-0058 | Lansoprazole | lansoprazole | Bryant Ranch Prepack | ANDA | Current |
| 71335-0058 | Lansoprazole | lansoprazole | Bryant Ranch Prepack | ANDA | Current |
| 71335-0058 | Lansoprazole | lansoprazole | Bryant Ranch Prepack | ANDA | Current |
| 71335-0660 | Lansoprazole | lansoprazole | Bryant Ranch Prepack | ANDA | Current |
| 71335-0660 | Lansoprazole | lansoprazole | Bryant Ranch Prepack | ANDA | Current |
| 71335-0917 | Lansoprazole | lansoprazole | Bryant Ranch Prepack | ANDA | Current |
| 71335-0917 | Lansoprazole | lansoprazole | Bryant Ranch Prepack | ANDA | Current |
| 71335-0917 | Lansoprazole | lansoprazole | Bryant Ranch Prepack | ANDA | Current |
| 71335-0917 | Lansoprazole | lansoprazole | Bryant Ranch Prepack | ANDA | Current |
| 72189-062 | LANSOPRAZOLE | LANSOPRAZOLE | DIRECT RX | ANDA | Current |
| 72189-062 | LANSOPRAZOLE | LANSOPRAZOLE | DIRECT RX | ANDA | Current |