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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 089414
Company: FOUGERA PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYDROCORTISONE HYDROCORTISONE 2.5% CREAM;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
12/16/1986 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-6 Labeling

Label is not available on this site.

03/07/1996 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

11/08/1995 SUPPL-4 Labeling

Label is not available on this site.

11/08/1995 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

HYDROCORTISONE

CREAM;TOPICAL; 2.5%
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ALA-CORT HYDROCORTISONE 2.5% CREAM;TOPICAL Prescription No AT 080706 CROWN LABS
ANUSOL HC HYDROCORTISONE 2.5% CREAM;TOPICAL Prescription No AT 088250 SALIX PHARMS
HYDROCORTISONE HYDROCORTISONE 2.5% CREAM;TOPICAL Prescription No AT 089682 ACTAVIS MID ATLANTIC
HYDROCORTISONE HYDROCORTISONE 2.5% CREAM;TOPICAL Prescription No AT 089414 FOUGERA PHARMS INC
HYDROCORTISONE HYDROCORTISONE 2.5% CREAM;TOPICAL Prescription No AT 085025 PADAGIS US
HYDROCORTISONE HYDROCORTISONE 2.5% CREAM;TOPICAL Prescription No AT 040879 RISING
HYDROCORTISONE HYDROCORTISONE 2.5% CREAM;TOPICAL Prescription No AT 088799 TARO PHARM INDS LTD
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