Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 085027
Company: PADAGIS US

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYDROCORTISONE HYDROCORTISONE 2.5% OINTMENT;TOPICAL Prescription AT No 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
11/30/1977 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
01/03/2000 SUPPL-21 Manufacturing (CMC)-Facility

Label is not available on this site.
08/18/1999 SUPPL-20 Labeling

Label is not available on this site.
08/18/1999 SUPPL-19 Manufacturing (CMC)-Packaging

Label is not available on this site.
08/18/1999 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.
06/18/1996 SUPPL-17 Labeling

Label is not available on this site.
08/14/1989 SUPPL-16 Labeling

Label is not available on this site.
06/11/1986 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.
06/02/1982 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.
07/07/1982 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

HYDROCORTISONE

OINTMENT;TOPICAL; 2.5%
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
HYDROCORTISONE HYDROCORTISONE 2.5% OINTMENT;TOPICAL Prescription No AT 081203 FOUGERA PHARMS INC
HYDROCORTISONE HYDROCORTISONE 2.5% OINTMENT;TOPICAL Prescription No AT 085027 PADAGIS US

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