Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018523
Company: BAXTER HLTHCARE

Products on NDA 018523

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ACETIC ACID 0.25% IN PLASTIC CONTAINER	ACETIC ACID, GLACIAL	250MG/100ML	SOLUTION;IRRIGATION, URETHRAL	Prescription	AT	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 018523

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/19/1982	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	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
09/26/2014	SUPPL-22	Manufacturing (CMC)		Label is not available on this site.
09/28/2011	SUPPL-20	Labeling-Container/Carton Labels		Label is not available on this site.
05/26/1999	SUPPL-15	Labeling		Label is not available on this site.
09/14/1993	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
09/30/1994	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
03/26/1991	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
11/14/1991	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
05/18/1990	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
07/26/1989	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
10/30/1986	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
06/26/1985	SUPPL-6	Labeling		Label is not available on this site.
02/28/1984	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
01/24/1985	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for NDA 018523

ACETIC ACID 0.25% IN PLASTIC CONTAINER

SOLUTION;IRRIGATION, URETHRAL; 250MG/100ML
TE Code = AT

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ACETIC ACID 0.25% IN PLASTIC CONTAINER	ACETIC ACID, GLACIAL	250MG/100ML	SOLUTION;IRRIGATION, URETHRAL	Prescription	No	AT	018161	B BRAUN
ACETIC ACID 0.25% IN PLASTIC CONTAINER	ACETIC ACID, GLACIAL	250MG/100ML	SOLUTION;IRRIGATION, URETHRAL	Prescription	No	AT	018523	BAXTER HLTHCARE
ACETIC ACID 0.25% IN PLASTIC CONTAINER	ACETIC ACID, GLACIAL	250MG/100ML	SOLUTION;IRRIGATION, URETHRAL	Prescription	Yes	AT	017656	ICU MEDICAL INC