ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION از شرکت SANOFI AVENTIS US

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ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION از شرکت SANOFI AVENTIS US

New Drug Application (NDA): 020786

Company: SANOFI AVENTIS US

Drug NameActive IngredientsStrengthDosage Form/RouteMarketing StatusTE CodeRLDRS
ALLEGRA-D 12 HOUR ALLERGY AND CONGESTIONFEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE;ORALOver-the-counter

None

YesYes
Original Approvals or Tentative Approvals
Action DateSubmissionAction TypeSubmission ClassificationReview Priority; Orphan StatusLetters, Reviews, Labels, Patient Package InsertNotesUrl
12/24/1997ORIG-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 DateSubmissionSupplement Categories or Approval TypeLetters, Reviews, Labels, Patient Package InsertNoteUrl
10/31/2016SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

10/31/2016SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

06/02/2016SUPPL-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

07/09/2015SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

06/08/2015SUPPL-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

05/14/2014SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

12/05/2012SUPPL-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

08/23/2012SUPPL-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

02/03/2012SUPPL-28 Manufacturing (CMC)

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/20786s028,021704s010ltr.pdf

01/24/2011SUPPL-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

04/14/2010SUPPL-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

12/06/2004SUPPL-17 Labeling

Label is not available on this site.

05/12/2003SUPPL-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

10/31/2001SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

11/01/2002SUPPL-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

10/29/2002SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

01/19/2001SUPPL-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

09/26/2000SUPPL-8 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/06/2000SUPPL-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

12/01/1999SUPPL-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

01/21/2000SUPPL-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

12/22/1998SUPPL-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

12/21/1999SUPPL-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

07/06/1998SUPPL-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 DateSubmissionSupplement Categories or Approval TypeLetters, Reviews, Labels,
Patient Package Insert
NoteUrl
06/02/2016SUPPL-35

Labeling-Container/Carton Labels

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020786Origs035,021704Orig1s018lbl.pdf
06/08/2015SUPPL-33

Efficacy-New Indication

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020786Orig1s033, 021704Orig1s017lbl.pdf
12/05/2012SUPPL-31

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020786s031lbl.pdf
08/23/2012SUPPL-29

Labeling-Container/Carton Labels

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020786s029lbl.pdf
01/24/2011SUPPL-27

Efficacy-Rx To OTC Switch

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020786Orig1s027lbl.pdf
04/14/2010SUPPL-26

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020786s026lbl.pdf
05/12/2003SUPPL-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 NameActive IngredientsStrengthDosage Form/RouteMarketing StatusRLDApplication No.Company
ALLEGRA-D 12 HOUR ALLERGY AND CONGESTIONFEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE;ORALOver-the-counterYes020786SANOFI AVENTIS US
FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE;ORALOver-the-counterNo209116AUROBINDO PHARMA LTD
FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE;ORALOver-the-counterNo076667DR REDDYS LABS LTD
FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE;ORALOver-the-counterNo090818SUN PHARM
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