Application 021428
- Type
- NDA
- Sponsor
- TAKEDA PHARMS USA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PREVACID | LANSOPRAZOLE | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL | 15MG | Yes | No |
| 002 | PREVACID | LANSOPRAZOLE | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL | 30MG | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 21695-106 | Prevacid SoluTab | lansoprazole | Rebel Distributors Corp | NDA | Current |
| 55154-0253 | Prevacid | lansoprazole | Cardinal Health | NDA | Current |
| 55154-0253 | Prevacid | lansoprazole | Cardinal Health 107, LLC | NDA | Current |
| 55154-0253 | Prevacid | lansoprazole | Cardinal Health | NDA | Current |
| 64764-543 | Prevacid SoluTab | lansoprazole | Takeda Pharmaceuticals America, Inc. | NDA | Current |
| 64764-543 | Prevacid SoluTab | lansoprazole | Takeda Pharmaceuticals America, Inc. | NDA | Current |
| 64764-543 | Prevacid SoluTab | lansoprazole | Takeda Pharmaceuticals America, Inc. | NDA | Current |
| 64764-543 | Prevacid SoluTab | lansoprazole | Takeda Pharmaceuticals America, Inc. | NDA | Current |
| 64764-543 | Prevacid SoluTab | lansoprazole | Takeda Pharmaceuticals America, Inc. | NDA | Current |
| 64764-543 | Prevacid SoluTab | lansoprazole | Takeda Pharmaceuticals America, Inc. | NDA | Current |
| 64764-543 | Prevacid SoluTab | lansoprazole | Takeda Pharmaceuticals America, Inc. | NDA | Current |
| 64764-544 | Prevacid SoluTab | lansoprazole | Takeda Pharmaceuticals America, Inc. | NDA | Current |
| 64764-544 | Prevacid SoluTab | lansoprazole | Takeda Pharmaceuticals America, Inc. | NDA | Current |
| 64764-544 | Prevacid SoluTab | lansoprazole | Takeda Pharmaceuticals America, Inc. | NDA | Current |
| 64764-544 | Prevacid SoluTab | lansoprazole | Takeda Pharmaceuticals America, Inc. | NDA | Current |
| 64764-544 | Prevacid SoluTab | lansoprazole | Takeda Pharmaceuticals America, Inc. | NDA | Current |
| 64764-544 | Prevacid SoluTab | lansoprazole | Takeda Pharmaceuticals America, Inc. | NDA | Current |
| 64764-544 | Prevacid SoluTab | lansoprazole | Takeda Pharmaceuticals America, Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 77890 | SUPPL | 2023-08-10 |
| 77891 | SUPPL | 2023-08-09 |
| 70479 | SUPPL | 2022-03-10 |
| 70464 | SUPPL | 2022-03-10 |
| 70410 | SUPPL | 2022-03-07 |
| 65415 | SUPPL | 2020-11-30 |
| 65414 | SUPPL | 2020-11-30 |
| 65376 | SUPPL | 2020-11-30 |
| 64587 | SUPPL | 2020-09-17 |
| 64568 | SUPPL | 2020-09-14 |
| 54573 | SUPPL | 2018-06-14 |
| 54572 | SUPPL | 2018-06-14 |
| 54518 | SUPPL | 2018-06-11 |
| 54517 | SUPPL | 2018-06-11 |
| 54516 | SUPPL | 2018-06-11 |
| 53708 | SUPPL | 2018-04-17 |
| 53695 | SUPPL | 2018-04-16 |
| 50184 | SUPPL | 2017-10-25 |
| 50101 | SUPPL | 2017-10-19 |
| 45713 | SUPPL | 2016-10-31 |
| 45663 | SUPPL | 2016-10-26 |
| 27750 | SUPPL | 2015-12-18 |
| 36899 | SUPPL | 2015-12-17 |
| 36900 | SUPPL | 2014-12-29 |
| 27751 | SUPPL | 2014-12-24 |
| 5349 | SUPPL | 2012-10-02 |
| 36898 | SUPPL | 2012-10-01 |
| 5350 | SUPPL | 2012-05-09 |
| 15447 | SUPPL | 2012-05-07 |
| 23659 | ORIG | 2011-12-20 |
| 15446 | SUPPL | 2011-11-01 |
| 27749 | SUPPL | 2011-10-31 |
| 36896 | SUPPL | 2011-06-07 |
| 5347 | SUPPL | 2011-06-03 |
| 36897 | SUPPL | 2011-05-26 |
| 5348 | SUPPL | 2011-05-25 |
| 15445 | SUPPL | 2010-09-10 |
| 36895 | SUPPL | 2010-05-17 |
| 5346 | SUPPL | 2010-05-17 |
| 27748 | SUPPL | 2009-11-12 |
| 15444 | SUPPL | 2009-08-13 |
| 15443 | SUPPL | 2008-11-07 |
| 27747 | SUPPL | 2008-10-29 |
| 21650 | SUPPL | 2008-07-31 |
| 5345 | SUPPL | 2008-04-23 |
| 5344 | SUPPL | 2007-07-05 |
| 15442 | SUPPL | 2007-06-27 |
| 36894 | SUPPL | 2006-04-13 |
| 5343 | SUPPL | 2006-04-13 |
| 42153 | ORIG | 2005-06-23 |
| 36893 | SUPPL | 2004-12-21 |
| 27746 | SUPPL | 2004-06-23 |
| 5342 | SUPPL | 2003-08-15 |
| 27745 | ORIG | 2002-08-30 |
| 15441 | ORIG | 2002-08-30 |