FDA Approval for CHILDREN'S ALLEGRA HIVES issued to CHATTEM SANOFI
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Biotechnology: Pharmaceutical Preparations
Health Care
New Drug Application (NDA): 021909
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 | TABLET, ORALLY DISINTEGRATING;ORAL | Discontinued | None | Yes | No |
| CHILDREN'S ALLEGRA HIVES | FEXOFENADINE HYDROCHLORIDE | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 07/26/2007 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021909lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021909s000_ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021909_allegra_toc.html |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/04/2026 | SUPPL-19 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 12/03/2020 | SUPPL-15 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021909Orig1s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021909Orig1s015ltr.pdf | |
| 08/05/2016 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/01/2016 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/10/2016 | SUPPL-10 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021909Orig1s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021909Orig1s010ltr.pdf | |
| 12/09/2013 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/31/2014 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/28/2013 | SUPPL-7 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021909Orig1s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021909Orig1s007ltr.pdf | |
| 08/23/2012 | SUPPL-6 | Labeling-Package Insert |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021909Orig1s006ltr.pdf |
| 01/24/2011 | SUPPL-3 | Efficacy-Rx To OTC Switch |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021909Orig1s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021909s003ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 12/03/2020 | SUPPL-15 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021909Orig1s015lbl.pdf | |
| 06/10/2016 | SUPPL-10 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021909Orig1s010lbl.pdf | |
| 04/28/2013 | SUPPL-7 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021909Orig1s007lbl.pdf | |
| 01/24/2011 | SUPPL-3 | Efficacy-Rx To OTC Switch | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021909Orig1s003lbl.pdf | |
| 07/26/2007 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021909lbl.pdf |