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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 207280
Company: RISING

Products on ANDA 207280

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 207280

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/09/2018	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 207280

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	SCIEGEN PHARMS INC
ACETIC ACID	ACETIC ACID, GLACIAL	2%	SOLUTION/DROPS;OTIC	Prescription	No	AT	088638	TARO

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