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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 085025
Company: PADAGIS US
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYDROCORTISONE HYDROCORTISONE 2.5% CREAM;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
04/21/1983 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
12/27/1999 SUPPL-18 Manufacturing (CMC)-Facility

Label is not available on this site.

05/08/1996 SUPPL-17 Labeling

Label is not available on this site.

05/08/1996 SUPPL-16 Manufacturing (CMC)

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.

06/30/1982 SUPPL-8 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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