Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019116
Company: BAUSCH

Products on NDA 019116

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019116

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.

Labels for NDA 019116

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

Therapeutic Equivalents for NDA 019116

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	BAUSCH