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CUTIVATE از شرکت FOUGERA PHARMS

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داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است

CUTIVATE از شرکت FOUGERA PHARMS

New Drug Application (NDA): 019957

Company: FOUGERA PHARMS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CUTIVATE FLUTICASONE PROPIONATE 0.005% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** OINTMENT;TOPICAL Discontinued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
12/14/1990 ORIG-1 Approval

Type 1 – New Molecular Entity

STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/19/2021 SUPPL-13 Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019957s013lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/019957Orig1s013ltr.pdf

02/18/2015 SUPPL-12 Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019957s012lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019957Orig1s012ltr.pdf

01/18/2002 SUPPL-11 Efficacy-New Patient Population

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19957s11lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19957s11ltr.pdf

06/07/2000 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

12/09/2001 SUPPL-9 Labeling

Label (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19957s9lbl.pdf

06/30/1999 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

12/09/2001 SUPPL-7 Labeling

Label (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19957s9lbl.pdf

11/12/1998 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

06/07/1995 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

10/07/1994 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

06/07/1994 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

10/07/1994 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

08/17/1995 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/19/2021 SUPPL-13

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019957s013lbl.pdf
02/18/2015 SUPPL-12

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019957s012lbl.pdf
01/18/2002 SUPPL-11

Efficacy-New Patient Population

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19957s11lbl.pdf
12/09/2001 SUPPL-9

Labeling

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19957s9lbl.pdf
12/09/2001 SUPPL-7

Labeling

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19957s9lbl.pdf
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