Application 021993
- Type
- NDA
- Sponsor
- BAYER HEALTHCARE LLC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | CLARITIN REDITABS | LORATADINE | TABLET, ORALLY DISINTEGRATING;ORAL | 5MG | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 11523-7202 | Claritin | Loratadine | Bayer HealthCare LLC | NDA | Current |
| 11523-7202 | Claritin | Loratadine | Bayer HealthCare LLC | NDA | Current |
| 11523-7202 | Claritin | Loratadine | Bayer HealthCare LLC | NDA | Current |
| 11523-7202 | Claritin | Loratadine | Bayer HealthCare LLC | NDA | Current |
| 11523-7202 | Claritin | Loratadine | Bayer HealthCare LLC | NDA | Current |
| 11523-7202 | Claritin | Loratadine | Bayer HealthCare LLC | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 74407 | SUPPL | 2023-05-30 |
| 74377 | SUPPL | 2023-05-26 |
| 57867 | SUPPL | 2019-03-01 |
| 57857 | SUPPL | 2019-03-01 |
| 55107 | SUPPL | 2018-08-03 |
| 54971 | SUPPL | 2018-07-25 |
| 38030 | SUPPL | 2015-12-01 |
| 29007 | SUPPL | 2015-11-27 |
| 38029 | SUPPL | 2014-07-29 |
| 6625 | SUPPL | 2014-07-24 |
| 6624 | SUPPL | 2008-10-23 |
| 42372 | ORIG | 2008-10-03 |
| 38028 | ORIG | 2006-12-14 |
| 29006 | ORIG | 2006-12-14 |