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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022076
Company: BAUSCH

Products on NDA 022076

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LOCOID	HYDROCORTISONE BUTYRATE	0.1%	LOTION;TOPICAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022076

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
10/18/2023	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022076s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/022076Orig1s006ltr.pdf
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.

Labels for NDA 022076

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/18/2023	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022076s006lbl.pdf
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

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