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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018514
Company: BAUSCH

Products on NDA 018514

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LOCOID	HYDROCORTISONE BUTYRATE	0.1%	CREAM;TOPICAL	Prescription	AB1	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 018514

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/31/1982	ORIG-1	Approval	Type 2 - New Active Ingredient	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-13	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018514s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018514Orig1s013ltr.pdf
01/08/2014	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
08/05/2013	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
12/12/2005	SUPPL-9	Manufacturing (CMC)-Control	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/018514s009ltr.pdf
05/22/2002	SUPPL-8	Manufacturing (CMC)	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18514s008ltr.pdf
08/30/1996	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
02/24/1995	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
02/14/1996	SUPPL-5	Manufacturing (CMC)-Formulation		Label is not available on this site.
04/25/1995	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
02/20/1985	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for NDA 018514

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/30/2014	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018514s013lbl.pdf

Therapeutic Equivalents for NDA 018514

LOCOID

CREAM;TOPICAL; 0.1%
TE Code = AB1

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
HYDROCORTISONE BUTYRATE	HYDROCORTISONE BUTYRATE	0.1%	CREAM;TOPICAL	Prescription	No	AB1	076654	TARO PHARM INDS
LOCOID	HYDROCORTISONE BUTYRATE	0.1%	CREAM;TOPICAL	Prescription	Yes	AB1	018514	BAUSCH

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