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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 086195
Company: MYLAN SPECIALITY LP
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROCTOFOAM HC HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE 1%;1% AEROSOL, METERED;TOPICAL Prescription BX 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
07/26/1978 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/21/2021 SUPPL-52 Labeling-Package Insert

Label is not available on this site.

08/11/2003 SUPPL-40 Labeling

Label is not available on this site.

01/03/2003 SUPPL-39 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/06/2004 SUPPL-38 Labeling

Label is not available on this site.

08/11/2003 SUPPL-37 Labeling

Label is not available on this site.

04/21/2000 SUPPL-36 Manufacturing (CMC)-Control

Label is not available on this site.

11/29/1999 SUPPL-35 Manufacturing (CMC)-Facility

Label is not available on this site.

01/12/1999 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

05/07/1998 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

08/07/1998 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

02/25/1998 SUPPL-31 Labeling

Label is not available on this site.

02/25/1998 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

02/25/1998 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

08/11/1997 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

06/03/1997 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

02/28/1997 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

01/26/1995 SUPPL-24 Labeling

Label is not available on this site.

11/16/1994 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

01/30/1991 SUPPL-22 Labeling

Label is not available on this site.

08/28/1990 SUPPL-21 Labeling

Label is not available on this site.

02/08/1989 SUPPL-20 Labeling

Label is not available on this site.

12/09/1985 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

09/01/1982 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

07/08/1983 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

04/30/1982 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

05/27/1982 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

04/30/1982 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

04/30/1982 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

04/30/1982 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

PROCTOFOAM HC

There are no Therapeutic Equivalents.

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