Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020786
Company: CHATTEM SANOFI
Company: CHATTEM SANOFI
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION | FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE | 60MG;120MG | TABLET, EXTENDED RELEASE;ORAL | Over-the-counter | None | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 12/24/1997 | ORIG-1 | Approval | Type 4 - New Combination | STANDARD |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020786_allegra-d_toc.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/31/2016 | SUPPL-39 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/31/2016 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/02/2016 | SUPPL-35 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020786Origs035,021704Orig1s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020786Orig1s035,021704Orig1s018ltr.pdf | |
| 07/09/2015 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/08/2015 | SUPPL-33 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020786Orig1s033, 021704Orig1s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020786Orig1s033,021704Orig1s017ltr.pdf | |
| 05/14/2014 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/05/2012 | SUPPL-31 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020786s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020786Orig1s031ltr.pdf | |
| 08/23/2012 | SUPPL-29 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020786s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020786Orig1s029ltr(r).pdf | |
| 02/03/2012 | SUPPL-28 | Manufacturing (CMC) |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/20786s028,021704s010ltr.pdf |
| 01/24/2011 | SUPPL-27 | Efficacy-Rx To OTC Switch |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020786Orig1s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020786s027ltr.pdf | |
| 04/14/2010 | SUPPL-26 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020786s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020786s026ltr.pdf | |
| 12/06/2004 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 05/12/2003 | SUPPL-14 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20786se8-014,20872se8-011,20625se8-012_allegra_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20786se8-014,20872se8-011,20625se8-012ltr.pdf | |
| 10/31/2001 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/01/2002 | SUPPL-12 | Labeling |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20786slr012ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020786_S012_ALLEGRA D.pdf |
| 10/29/2002 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/19/2001 | SUPPL-9 | Manufacturing (CMC)-Control |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020786_s009_ALLEGRA D.pdf |
| 09/26/2000 | SUPPL-8 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/06/2000 | SUPPL-6 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020786_s006_ALLEGRA CAPSULES.pdf |
| 12/01/1999 | SUPPL-5 | Manufacturing (CMC)-Control |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020786_s005_ALLEGRA D.pdf |
| 01/21/2000 | SUPPL-4 | Manufacturing (CMC)-Control |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020786_s004_ALLEGRA CAPSULES.pdf |
| 12/22/1998 | SUPPL-3 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020786_s003_ALLEGRA TABS.pdf |
| 12/21/1999 | SUPPL-2 | Manufacturing (CMC)-Control |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020786_s002_ALLEGRA D.pdf |
| 07/06/1998 | SUPPL-1 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020786_s001_ALLEGRA TABS.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 06/02/2016 | SUPPL-35 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020786Origs035,021704Orig1s018lbl.pdf | |
| 06/08/2015 | SUPPL-33 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020786Orig1s033, 021704Orig1s017lbl.pdf | |
| 12/05/2012 | SUPPL-31 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020786s031lbl.pdf | |
| 08/23/2012 | SUPPL-29 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020786s029lbl.pdf | |
| 01/24/2011 | SUPPL-27 | Efficacy-Rx To OTC Switch | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020786Orig1s027lbl.pdf | |
| 04/14/2010 | SUPPL-26 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020786s026lbl.pdf | |
| 05/12/2003 | SUPPL-14 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20786se8-014,20872se8-011,20625se8-012_allegra_lbl.pdf |
ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
TABLET, EXTENDED RELEASE;ORAL; 60MG;120MG
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION | FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE | 60MG;120MG | TABLET, EXTENDED RELEASE;ORAL | Over-the-counter | Yes | 020786 | CHATTEM SANOFI |
| FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE | 60MG;120MG | TABLET, EXTENDED RELEASE;ORAL | Over-the-counter | No | 209116 | AUROBINDO PHARMA |
| FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE | 60MG;120MG | TABLET, EXTENDED RELEASE;ORAL | Over-the-counter | No | 076667 | DR REDDYS |
| FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE | 60MG;120MG | TABLET, EXTENDED RELEASE;ORAL | Over-the-counter | No | 215434 | DR REDDYS |
| FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE | FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE | 60MG;120MG | TABLET, EXTENDED RELEASE;ORAL | Over-the-counter | No | 090818 | SUN PHARM |