Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018652
Company: PRECISION DERMAT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LOCOID HYDROCORTISONE BUTYRATE 0.1% OINTMENT;TOPICAL Prescription AB 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
10/29/1982 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-10 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018652s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018652Orig1s010ltr.pdf
05/03/2013 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

07/16/1996 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

02/24/1995 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

04/25/1995 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

02/20/1985 SUPPL-1 Manufacturing (CMC)-Control

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-10 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018652s010lbl.pdf

LOCOID

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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