Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076364
Company: TARO PHARM INDS

Products on ANDA 076364

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
HYDROCORTISONE BUTYRATE	HYDROCORTISONE BUTYRATE	0.1%	SOLUTION;TOPICAL	Prescription	AT	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076364

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/14/2004	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76364ltr.pdf

Therapeutic Equivalents for ANDA 076364

HYDROCORTISONE BUTYRATE

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