Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076654
Company: TARO PHARM INDS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYDROCORTISONE BUTYRATE HYDROCORTISONE BUTYRATE 0.1% CREAM;TOPICAL Prescription AB1 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
08/03/2005 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/076654lt.pdf

HYDROCORTISONE BUTYRATE

CREAM;TOPICAL; 0.1%
TE Code = AB1

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
HYDROCORTISONE BUTYRATE HYDROCORTISONE BUTYRATE 0.1% CREAM;TOPICAL Prescription No AB1 076654 TARO PHARM INDS
LOCOID HYDROCORTISONE BUTYRATE 0.1% CREAM;TOPICAL Prescription Yes AB1 018514 BAUSCH

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