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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 017351
Company: MYLAN SPECIALITY LP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CORTIFOAM HYDROCORTISONE ACETATE 10% AEROSOL, METERED;RECTAL Prescription 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
02/12/1982 ORIG-1 Approval Type 3 - New Dosage Form 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
03/01/2024 SUPPL-41 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/017351s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/017351Orig1s041ltr.pdf
10/03/2014 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.
12/05/2003 SUPPL-30 Labeling Letter (PDF)
Review

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/17351slr030ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/017351_s030_CortifoamTOC.cfm
11/20/2002 SUPPL-28 Manufacturing (CMC)-Packaging

Label is not available on this site.
07/08/2002 SUPPL-27 Labeling Letter (PDF)
Review

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17351slr027ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/17-351s027_Cortifoam.cfm
12/01/1999 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.
08/05/1999 SUPPL-25 Manufacturing (CMC)-Packaging

Label is not available on this site.
08/21/1998 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.
06/08/1998 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.
03/16/1998 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.
12/27/1996 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.
12/27/1996 SUPPL-20 Manufacturing (CMC)-Packaging

Label is not available on this site.
05/13/1997 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.
11/29/1996 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.
03/28/1996 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.
07/17/1995 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.
05/02/1995 SUPPL-15 Manufacturing (CMC)-Packaging

Label is not available on this site.
12/05/1994 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.
11/05/1993 SUPPL-13 Manufacturing (CMC)-Packaging

Label is not available on this site.
10/15/1993 SUPPL-12 Labeling

Label is not available on this site.
04/24/1986 SUPPL-11 Manufacturing (CMC)-Packaging

Label is not available on this site.
11/20/1984 SUPPL-10 Manufacturing (CMC)-Expiration Date

Label is not available on this site.
04/26/1983 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.
12/30/1982 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.
09/16/1982 SUPPL-5 Manufacturing (CMC)-Packaging

Label is not available on this site.
06/06/1985 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.
02/10/1982 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.
02/10/1982 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
03/01/2024 SUPPL-41 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/017351s041lbl.pdf
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