ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION از شرکت SANOFI AVENTIS US

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ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION از شرکت SANOFI AVENTIS US

New Drug Application (NDA): 021704

Company: SANOFI AVENTIS US

Drug NameActive IngredientsStrengthDosage Form/RouteMarketing StatusTE CodeRLDRS
ALLEGRA-D 24 HOUR ALLERGY AND CONGESTIONFEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE180MG;240MGTABLET, EXTENDED RELEASE;ORALOver-the-counter

None

YesYes
Original Approvals or Tentative Approvals
Action DateSubmissionAction TypeSubmission ClassificationReview Priority; Orphan StatusLetters, Reviews, Labels, Patient Package InsertNotesUrl
10/19/2004ORIG-1 Approval

Type 3 – New Dosage Form

STANDARD

Label (PDF)

Letter (PDF)

Review

https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21704lbl.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21704ltr.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021704s000_AllegraTOC.cfm

Supplements
Action DateSubmissionSupplement Categories or Approval TypeLetters, Reviews, Labels, Patient Package InsertNoteUrl
10/31/2016SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

06/02/2016SUPPL-18 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

06/08/2015SUPPL-17 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

01/30/2014SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

10/18/2013SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

01/06/2014SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

12/05/2012SUPPL-13 Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021704s013lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021704Orig1s013ltr.pdf

08/23/2012SUPPL-11 Labeling-Container/Carton Labels

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021704Org1s011ltr.pdf

02/03/2012SUPPL-10 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-8 Efficacy-Rx To OTC Switch

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021704Orig1s008lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021704s008ltr.pdf

04/14/2010SUPPL-7 Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021704s007lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021704s007ltr.pdf

Action DateSubmissionSupplement Categories or Approval TypeLetters, Reviews, Labels,
Patient Package Insert
NoteUrl
06/02/2016SUPPL-18

Labeling-Container/Carton Labels

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020786Origs035,021704Orig1s018lbl.pdf
06/08/2015SUPPL-17

Efficacy-New Indication

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020786Orig1s033, 021704Orig1s017lbl.pdf
12/05/2012SUPPL-13

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021704s013lbl.pdf
01/24/2011SUPPL-8

Efficacy-Rx To OTC Switch

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021704Orig1s008lbl.pdf
04/14/2010SUPPL-7

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021704s007lbl.pdf
10/19/2004ORIG-1 Approval

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21704lbl.pdf

ALLEGRA-D 24 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; 180MG;240MG
Drug NameActive IngredientsStrengthDosage Form/RouteMarketing StatusRLDApplication No.Company
ALLEGRA-D 24 HOUR ALLERGY AND CONGESTIONFEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE180MG;240MGTABLET, EXTENDED RELEASE;ORALOver-the-counterYes021704SANOFI AVENTIS US
FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE180MG;240MGTABLET, EXTENDED RELEASE;ORALOver-the-counterNo079043DR REDDYS LABS LTD
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