Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076842
Company: TARO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYDROCORTISONE BUTYRATE HYDROCORTISONE BUTYRATE 0.1% OINTMENT;TOPICAL Prescription AB 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
12/27/2004 ORIG-1 Approval

Label is not available on this site.

HYDROCORTISONE BUTYRATE

OINTMENT;TOPICAL; 0.1%
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
HYDROCORTISONE BUTYRATE HYDROCORTISONE BUTYRATE 0.1% OINTMENT;TOPICAL Prescription No AB 076842 TARO
LOCOID HYDROCORTISONE BUTYRATE 0.1% OINTMENT;TOPICAL Prescription Yes AB 018652 PRECISION DERMAT

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