ALLEGRA از شرکت SANOFI AVENTIS US

اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است

ALLEGRA از شرکت SANOFI AVENTIS US

New Drug Application (NDA): 020625

Company: SANOFI AVENTIS US

Drug NameActive IngredientsStrengthDosage Form/RouteMarketing StatusTE CodeRLDRS
ALLEGRAFEXOFENADINE HYDROCHLORIDE60MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**CAPSULE;ORALDiscontinued

None

NoNo
Original Approvals or Tentative Approvals
Action DateSubmissionAction TypeSubmission ClassificationReview Priority; Orphan StatusLetters, Reviews, Labels, Patient Package InsertNotesUrl
07/25/1996ORIG-1 Approval

Type 1 – New Molecular Entity

STANDARD

Label (PDF)

Review (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20625lbl.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020625Orig1s000rev.pdf

Supplements
Action DateSubmissionSupplement Categories or Approval TypeLetters, Reviews, Labels, Patient Package InsertNoteUrl
05/12/2003SUPPL-12 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

07/11/2001SUPPL-11 Labeling

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20625s11ltr.pdf

05/12/2003SUPPL-10 Efficacy-Labeling Change With Clinical Data

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20872se8-003,20625se8-010_allegra_lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20872se8-003,20625se8-010ltr.pdf

01/06/2000SUPPL-9 Manufacturing (CMC)

Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020625_s009_ALLEGRA TABLETS.pdf

01/21/2000SUPPL-8 Manufacturing (CMC)-Control

Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020625_s008_ALLEGRA_TABLETS.pdf

12/22/1998SUPPL-7 Labeling

Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020625_s007_ALLEGRA TABLETS.pdf

07/06/1998SUPPL-6 Manufacturing (CMC)

Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020625_s006_ALLEGRA TABLETS.pdf

01/29/1998SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

01/28/1997SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

10/16/1996SUPPL-1 Manufacturing (CMC)-Packaging

Label is not available on this site.

Action DateSubmissionSupplement Categories or Approval TypeLetters, Reviews, Labels,
Patient Package Insert
NoteUrl
05/12/2003SUPPL-12

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
05/12/2003SUPPL-10

Efficacy-Labeling Change With Clinical Data

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20872se8-003,20625se8-010_allegra_lbl.pdf
07/25/1996ORIG-1 Approval

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20625lbl.pdf
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