Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 201373
Company: CHATTEM SANOFI
Company: CHATTEM SANOFI
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CHILDREN'S ALLEGRA ALLERGY | FEXOFENADINE HYDROCHLORIDE | 30MG/5ML | SUSPENSION;ORAL | Over-the-counter | None | Yes | Yes |
| CHILDREN'S ALLEGRA HIVES | FEXOFENADINE HYDROCHLORIDE | 30MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUSPENSION;ORAL | Discontinued | None | Yes | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 01/24/2011 | ORIG-1 | Approval | Type 8 - Partial Rx to OTC Switch | STANDARD |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/201373Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/201373s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/201373_allegra_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/201373Orig1s000SumR.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/27/2022 | SUPPL-13 | Manufacturing (CMC)-Packaging |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/201373Orig1s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/201373Orig1s013ltr.pdf | |
| 12/20/2022 | SUPPL-12 | Manufacturing (CMC)-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/201373Orig1s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/201373Orig1s012ltr.pdf | |
| 03/17/2021 | SUPPL-11 | Manufacturing (CMC)-Formulation |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/201373Orig1s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/201373Orig1s011ltr.pdf | |
| 11/02/2020 | SUPPL-10 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/201373Orig1s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/201373Orig1s010ltr.pdf | |
| 06/15/2016 | SUPPL-6 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201373Orig1s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/201373Orig1s006ltr.pdf | |
| 04/28/2013 | SUPPL-5 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/201373Orig1s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/201373Orig1s005ltr.pdf | |
| 08/23/2012 | SUPPL-4 | Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/201373Orig1s004ltr.pdf |
| 02/23/2012 | SUPPL-2 | Labeling-Package Insert |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/201373s002ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 12/27/2022 | SUPPL-13 | Manufacturing (CMC)-Packaging | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/201373Orig1s013lbl.pdf | |
| 12/20/2022 | SUPPL-12 | Manufacturing (CMC)-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/201373Orig1s012lbl.pdf | |
| 03/17/2021 | SUPPL-11 | Manufacturing (CMC)-Formulation | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/201373Orig1s011lbl.pdf | |
| 11/02/2020 | SUPPL-10 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/201373Orig1s010lbl.pdf | |
| 06/15/2016 | SUPPL-6 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201373Orig1s006lbl.pdf | |
| 04/28/2013 | SUPPL-5 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/201373Orig1s005lbl.pdf | |
| 01/24/2011 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/201373Orig1s000lbl.pdf |
CHILDREN'S ALLEGRA ALLERGY
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
SUSPENSION;ORAL; 30MG/5ML
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| CHILDREN'S ALLEGRA ALLERGY | FEXOFENADINE HYDROCHLORIDE | 30MG/5ML | SUSPENSION;ORAL | Over-the-counter | Yes | 201373 | CHATTEM SANOFI |
| CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 30MG/5ML | SUSPENSION;ORAL | Over-the-counter | No | 203330 | P AND L |
| CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 30MG/5ML | SUSPENSION;ORAL | Over-the-counter | No | 208123 | TARO |
| CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES | FEXOFENADINE HYDROCHLORIDE | 30MG/5ML | SUSPENSION;ORAL | Over-the-counter | No | 203330 | P AND L |
| CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES | FEXOFENADINE HYDROCHLORIDE | 30MG/5ML | SUSPENSION;ORAL | Over-the-counter | No | 208123 | TARO |
| FEXOFENADINE HYDROCHLORIDE | FEXOFENADINE HYDROCHLORIDE | 30MG/5ML | SUSPENSION;ORAL | Over-the-counter | No | 213466 | AUROBINDO PHARMA LTD |
CHILDREN'S ALLEGRA HIVES
There are no other OTC drugs with the same Active Ingredient, Strength and Dosage Form/Route.