Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040609
Company: COSETTE

Products on ANDA 040609

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
HYDROCORTISONE AND ACETIC ACID	ACETIC ACID, GLACIAL; HYDROCORTISONE	2%;1%	SOLUTION/DROPS;OTIC	Prescription	AT	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040609

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/06/2006	ORIG-1	Approval				Label is not available on this site.

Therapeutic Equivalents for ANDA 040609

HYDROCORTISONE AND ACETIC ACID

SOLUTION/DROPS;OTIC; 2%;1%
TE Code = AT

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
HYDROCORTISONE AND ACETIC ACID	ACETIC ACID, GLACIAL; HYDROCORTISONE	2%;1%	SOLUTION/DROPS;OTIC	Prescription	No	AT	040609	COSETTE
HYDROCORTISONE AND ACETIC ACID	ACETIC ACID, GLACIAL; HYDROCORTISONE	2%;1%	SOLUTION/DROPS;OTIC	Prescription	Yes	AT	088759	TARO
VOSOL HC	ACETIC ACID, GLACIAL; HYDROCORTISONE	2%;1%	SOLUTION/DROPS;OTIC	Prescription	Yes	AT	012770	SAPTALIS PHARMS