Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076364
Company: TARO PHARM INDS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYDROCORTISONE BUTYRATE HYDROCORTISONE BUTYRATE 0.1% SOLUTION;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
01/14/2004 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76364ltr.pdf

HYDROCORTISONE BUTYRATE

SOLUTION;TOPICAL; 0.1%
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
HYDROCORTISONE BUTYRATE HYDROCORTISONE BUTYRATE 0.1% SOLUTION;TOPICAL Prescription No AT 076364 TARO PHARM INDS
LOCOID HYDROCORTISONE BUTYRATE 0.1% SOLUTION;TOPICAL Prescription Yes AT 019116 BAUSCH

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