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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040607
Company: SAPTALIS PHARMS

Products on ANDA 040607

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040607

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/24/2005	ORIG-1	Approval				Label is not available on this site.

Therapeutic Equivalents for ANDA 040607

ACETIC ACID

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

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ACETIC ACID	ACETIC ACID, GLACIAL	2%	SOLUTION/DROPS;OTIC	Prescription	No	AT	207280	RISING
ACETIC ACID	ACETIC ACID, GLACIAL	2%	SOLUTION/DROPS;OTIC	Prescription	No	AT	040607	SAPTALIS PHARMS
ACETIC ACID	ACETIC ACID, GLACIAL	2%	SOLUTION/DROPS;OTIC	Prescription	No	AT	088638	TARO
VOSOL	ACETIC ACID, GLACIAL	2%	SOLUTION/DROPS;OTIC	Prescription	No	AT	012179	HIKMA

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