Application 022363
- Type
- NDA
- Sponsor
- KOWA CO
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LIVALO | PITAVASTATIN CALCIUM | TABLET;ORAL | EQ 1MG BASE | Yes | No |
| 002 | LIVALO | PITAVASTATIN CALCIUM | TABLET;ORAL | EQ 2MG BASE | Yes | No |
| 003 | LIVALO | PITAVASTATIN CALCIUM | TABLET;ORAL | EQ 4MG BASE | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 66869-104 | Livalo | pitavastatin calcium | Kowa Pharmaceuticals America, Inc. | NDA | Current |
| 66869-104 | Livalo | pitavastatin calcium | Kowa Pharmaceuticals America, Inc. | NDA | Current |
| 66869-104 | Livalo | pitavastatin calcium | Kowa Pharmaceuticals America, Inc. | NDA | Current |
| 66869-204 | Livalo | pitavastatin calcium | Kowa Pharmaceuticals America, Inc. | NDA | Current |
| 66869-204 | Livalo | pitavastatin calcium | Kowa Pharmaceuticals America, Inc. | NDA | Current |
| 66869-204 | Livalo | pitavastatin calcium | Kowa Pharmaceuticals America, Inc. | NDA | Current |
| 66869-404 | Livalo | pitavastatin calcium | Kowa Pharmaceuticals America, Inc. | NDA | Current |
| 66869-404 | Livalo | pitavastatin calcium | Kowa Pharmaceuticals America, Inc. | NDA | Current |
| 66869-404 | Livalo | pitavastatin calcium | Kowa Pharmaceuticals America, Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 77844 | SUPPL | 2024-03-15 |
| 77837 | SUPPL | 2024-03-15 |
| 72596 | SUPPL | 2022-11-10 |
| 72595 | SUPPL | 2022-11-10 |
| 64731 | SUPPL | 2020-09-29 |
| 64704 | SUPPL | 2020-09-28 |
| 60614 | SUPPL | 2019-10-22 |
| 60610 | SUPPL | 2019-10-21 |
| 58820 | SUPPL | 2019-05-21 |
| 58772 | SUPPL | 2019-05-17 |
| 45918 | SUPPL | 2016-11-22 |
| 45936 | SUPPL | 2016-11-21 |
| 38627 | SUPPL | 2013-10-18 |
| 29657 | SUPPL | 2013-10-18 |
| 38626 | SUPPL | 2012-11-06 |
| 29656 | SUPPL | 2012-11-06 |
| 22004 | SUPPL | 2012-04-24 |
| 22003 | SUPPL | 2012-03-30 |
| 38625 | SUPPL | 2012-02-28 |
| 29655 | SUPPL | 2012-02-28 |
| 17297 | SUPPL | 2012-02-28 |
| 7297 | SUPPL | 2012-02-28 |
| 29654 | SUPPL | 2011-08-05 |
| 17296 | SUPPL | 2011-08-05 |
| 29653 | SUPPL | 2011-06-27 |
| 17295 | SUPPL | 2011-06-16 |
| 7296 | SUPPL | 2010-06-08 |
| 42500 | ORIG | 2009-11-23 |
| 38624 | ORIG | 2009-08-26 |
| 7295 | ORIG | 2009-08-26 |
| 64049 | ORIG | 1900-01-01 |
| 64048 | ORIG | 1900-01-01 |
| 63238 | SUPPL | 1900-01-01 |
| 63237 | SUPPL | 1900-01-01 |
| 63236 | SUPPL | 1900-01-01 |
| 63235 | SUPPL | 1900-01-01 |