Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 081203
Company: FOUGERA PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYDROCORTISONE HYDROCORTISONE 2.5% OINTMENT;TOPICAL Prescription AT No 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
05/28/1993 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
04/01/1997 SUPPL-7 Labeling

Label is not available on this site.

03/07/1996 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

03/06/1996 SUPPL-5 Labeling

Label is not available on this site.

03/06/1996 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

11/06/1995 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

03/06/1996 SUPPL-2 Labeling

Label is not available on this site.

03/06/1996 SUPPL-1 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 PERRIGO NEW YORK

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