Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 080706
Company: CROWN LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ALA-CORT HYDROCORTISONE 1% CREAM;TOPICAL Prescription AT No No
ALA-CORT 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
03/09/1973 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
09/22/2015 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

01/28/1997 SUPPL-8 Labeling

Label is not available on this site.

05/22/1992 SUPPL-7 Labeling

Label is not available on this site.

07/10/1985 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

07/10/1985 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

05/12/1982 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

ALA-CORT

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

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 PERRIGO NEW YORK
HYDROCORTISONE HYDROCORTISONE 2.5% CREAM;TOPICAL Prescription No AT 040879 RISING PHARMS INC
HYDROCORTISONE HYDROCORTISONE 2.5% CREAM;TOPICAL Prescription No AT 088799 TARO
HYDROCORTISONE HYDROCORTISONE 2.5% CREAM;TOPICAL Prescription No AT 040503 VINTAGE PHARMS

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