Application 201373
- Type
- NDA
- Sponsor
- SANOFI AVENTIS US
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CHILDREN'S ALLEGRA ALLERGY | FEXOFENADINE HYDROCHLORIDE | SUSPENSION;ORAL | 30MG/5ML | Yes | Yes |
| 002 | CHILDREN'S ALLEGRA HIVES | FEXOFENADINE HYDROCHLORIDE | SUSPENSION;ORAL | 30MG/5ML | Yes | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 41167-4244 | Childrens Allegra Allergy | Fexofenadine Hydrochloride | Chattem, Inc. | NDA | Current |
| 41167-4244 | Childrens Allegra Allergy | Fexofenadine Hydrochloride | Chattem, Inc. | NDA | Current |
| 41167-4244 | Childrens Allegra Allergy | Fexofenadine Hydrochloride | Chattem, Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 73069 | SUPPL | 2023-01-03 |
| 73060 | SUPPL | 2022-12-28 |
| 72956 | SUPPL | 2022-12-20 |
| 72929 | SUPPL | 2022-12-20 |
| 68015 | SUPPL | 2021-07-06 |
| 68012 | SUPPL | 2021-07-06 |
| 65972 | SUPPL | 2021-01-25 |
| 65130 | SUPPL | 2020-11-03 |
| 9892 | SUPPL | 2016-06-21 |
| 19016 | SUPPL | 2016-06-17 |
| 40069 | ORIG | 2013-11-26 |
| 40070 | SUPPL | 2013-10-02 |
| 32110 | SUPPL | 2013-04-30 |
| 9891 | SUPPL | 2012-08-27 |
| 9890 | SUPPL | 2012-02-27 |
| 24392 | ORIG | 2011-10-07 |
| 22851 | ORIG | 2011-10-07 |
| 9889 | ORIG | 2011-02-02 |