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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 088799
Company: TARO PHARM INDS LTD
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
11/09/1984 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
04/28/2005 SUPPL-30 Labeling

Label is not available on this site.

07/28/2005 SUPPL-27 Labeling

Label is not available on this site.

04/29/1993 SUPPL-25 Labeling

Label is not available on this site.

11/16/1992 SUPPL-16 Labeling

Label is not available on this site.

02/21/1992 SUPPL-14 Labeling

Label is not available on this site.

12/17/1990 SUPPL-13 Labeling

Label is not available on this site.

07/13/1989 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

07/13/1989 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

05/05/1989 SUPPL-10 Labeling

Label is not available on this site.

03/28/1990 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

03/28/1990 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

07/24/1986 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

12/06/1985 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

04/03/1985 SUPPL-1 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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