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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 080693
Company: FOUGERA PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYDROCORTISONE HYDROCORTISONE 1% 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
04/30/1976 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
03/07/1996 SUPPL-51 Manufacturing (CMC)

Label is not available on this site.

06/10/1996 SUPPL-50 Manufacturing (CMC)

Label is not available on this site.

07/30/1987 SUPPL-48 Manufacturing (CMC)

Label is not available on this site.

02/10/1986 SUPPL-46 Manufacturing (CMC)

Label is not available on this site.

02/10/1986 SUPPL-45 Manufacturing (CMC)

Label is not available on this site.

02/10/1986 SUPPL-44 Manufacturing (CMC)

Label is not available on this site.

01/26/1984 SUPPL-43 Manufacturing (CMC)

Label is not available on this site.

05/11/1982 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

HYDROCORTISONE

CREAM;TOPICAL; 1%
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ALA-CORT HYDROCORTISONE 1% CREAM;TOPICAL Prescription No AT 080706 CROWN LABS
HYDROCORTISONE HYDROCORTISONE 1% CREAM;TOPICAL Prescription No AT 087795 ACTAVIS MID ATLANTIC
HYDROCORTISONE HYDROCORTISONE 1% CREAM;TOPICAL Prescription No AT 080693 FOUGERA PHARMS INC
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