Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022076
Company: BAUSCH
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LOCOID HYDROCORTISONE BUTYRATE 0.1% LOTION;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
05/18/2007 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022076lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022076s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022076_locoid_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/30/2014 SUPPL-5 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022076s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022076Orig1s005ltr.pdf
11/19/2013 SUPPL-4 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-5 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022076s005lbl.pdf
05/18/2007 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022076lbl.pdf

LOCOID

LOTION;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% LOTION;TOPICAL Prescription No AB 210209 LUPIN LTD
HYDROCORTISONE BUTYRATE HYDROCORTISONE BUTYRATE 0.1% LOTION;TOPICAL Prescription No AB 209556 TELIGENT
LOCOID HYDROCORTISONE BUTYRATE 0.1% LOTION;TOPICAL Prescription Yes AB 022076 BAUSCH

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