Application 202194
- 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 |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0363-0739 | Lansoprazole | Lansoprazole | Walgreen Co | ANDA | Current |
| 0363-0739 | Lansoprazole | Lansoprazole | Walgreen Co | ANDA | Current |
| 0363-0739 | Lansoprazole | Lansoprazole | Walgreen Co | ANDA | Current |
| 0536-1324 | Lansoprazole | Lansoprazole | Rugby Laboratories | ANDA | Current |
| 0536-1368 | Lansoprazole | Lansoprazole | Rugby Laboratories, Inc | ANDA | Current |
| 11822-0016 | Lansoprazole | Lansoprazole | Rite Aid Corporation | ANDA | Current |
| 11822-0019 | Lansoprazole | Lansoprazole | Rite Aid Corporation | ANDA | Current |
| 11822-0019 | Lansoprazole | Lansoprazole | Rite Aid Corporation | ANDA | Current |
| 21130-046 | Lansoprazole | Lansoprazole | Albertsons Companies | ANDA | Current |
| 30142-288 | Lansoprazole | Lansoprazole | Kroger Company | ANDA | Current |
| 30142-983 | Lansoprazole | Lansoprazole | Kroger Company | ANDA | Current |
| 43598-109 | Lansoprazole | Lansoprazole | Dr. Reddy's Laboratories Inc. | ANDA | Current |
| 43598-109 | Lansoprazole | Lansoprazole | Dr. Reddy's Laboratories Inc. | ANDA | Current |
| 43598-161 | Lansoprazole | Lansoprazole | Dr. Reddy's Laboratories Inc. | ANDA | Current |
| 43598-883 | Lansoprazole | Lansoprazole | Dr. Reddy's Laboratories Inc. | ANDA | Current |
| 49035-739 | Lansoprazole | Lansoprazole | Wal-Mart Stores Inc | ANDA | Current |
| 49035-739 | Lansoprazole | Lansoprazole | Wal-Mart Stores Inc | ANDA | Current |
| 49035-739 | Lansoprazole | Lansoprazole | Wal-Mart Stores Inc | ANDA | Current |
| 51316-006 | Lansoprazole | Lansoprazole | CVS Pharmacy, Inc | ANDA | Current |
| 55111-739 | Lansoprazole | Lansoprazole | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-739 | Lansoprazole | Lansoprazole | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 55111-739 | Lansoprazole | Lansoprazole | Dr. Reddy's Laboratories Limited | ANDA | Current |
| 57896-761 | Lansoprazole | Lansoprazole | Gericare Pharmaceuticals | ANDA | Current |
| 63868-429 | Lansoprazole | Lansoprazole | Chain Drug Marketing Association | ANDA | Current |
| 69618-055 | Lansoprazole | Lansoprazole | Reliable 1 Laboratories | ANDA | Current |
| 69842-270 | Lansoprazole | Lansoprazole | CVS Health Corp | ANDA | Current |
| 70000-0069 | Lansoprazole | Lansoprazole | Cardinal Health | ANDA | Current |
| 70000-0069 | Lansoprazole | Lansoprazole | Cardinal Health | ANDA | Current |
| 70000-0612 | Lansoprazole | Lansoprazole | Cardinal Health | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 43388 | ORIG | 2014-01-17 |
| 9989 | ORIG | 2012-05-22 |