Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019116
Company: PRECISION DERMAT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LOCOID HYDROCORTISONE BUTYRATE 0.1% SOLUTION;TOPICAL Prescription AT Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
02/25/1987 ORIG-1 Approval Type 3 - New Dosage Form STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/30/2014 SUPPL-9 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019116s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019116Orig1s009ltr.pdf
05/03/2013 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

05/09/2002 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

08/30/1996 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

11/25/1994 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/30/2014 SUPPL-9 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019116s009lbl.pdf

LOCOID

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 PRECISION DERMAT

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