Acetic Acid Irrigation Solution

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Baxter Healthcare Corporation (2015-04-15)
Oldest Current Product
1979-08-06
License(s)
NDA
RxNORM
IRRIGATION SOLUTION\ACETIC ACID
FDAOB
IRRIGATION, URETHRAL\SOLUTION\ACETIC ACID, GLACIAL\rdfq
SPL Active
IRRIGATION\IRRIGANT\ACETIC ACID
SPL Moiety
IRRIGATION\IRRIGANT\ACETIC ACID

product(s) by strength(s)

acetic acid 2.5 mg/ml irrigation solution

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1002642304NDAB. Braun Medical Inc.1979-08-06ACETIC ACIDIRRIGATIONIRRIGANTNDA018161dd45cee3-9938-4dad-a5e1-1dd4baea85a9
2003380656NDABaxter Healthcare Corporation1982-02-19ACETIC ACIDIRRIGATIONIRRIGANTNDA01852341bc12af-fac5-4ac1-b907-dcb3e35a054c

application(s)

#idtitleapplicantapprovedapproved drug
1NDA017656ACETIC ACID 0.25% IN PLASTIC CONTAINERHOSPIRA INCNDA017656_001
2NDA018161ACETIC ACID 0.25% IN PLASTIC CONTAINERB BRAUN MEDICAL INCNDA018161_001
3NDA018523ACETIC ACID 0.25% IN PLASTIC CONTAINERBAXTER HEALTHCARE CORP1982-02-19NDA018523_001

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1NDA017656_001RXACETIC ACID, GLACIAL (250MG/100ML)SOLUTIONFalseATACETIC ACID 0.25% IN PLASTIC CONTAINER
2NDA018161_001RXACETIC ACID, GLACIAL (250MG/100ML)SOLUTIONFalseATACETIC ACID 0.25% IN PLASTIC CONTAINER
3NDA018523_001RXACETIC ACID, GLACIAL (250MG/100ML)SOLUTIONFalseAT1982-02-19ACETIC ACID 0.25% IN PLASTIC CONTAINER

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
141bc12af-fac5-4ac1-b907-dcb3e35a054c (view SPL)0.25% Acetic Acid Irrigation, USPin Plastic Pour BottleprescriptionHuman PrescriptionBaxter Healthcare CorporationANALYSIS, LABEL, MANUFACTURE, PACK, STERILIZE2015-04-154003380656
24e8c4367-accb-42f8-5eaa-3c57d7674b7d (view SPL)0.25% ACETIC ACID IRRIGATION, USPprescriptionHuman PrescriptionHospira, Inc.2012-05-1010004096143
3dd45cee3-9938-4dad-a5e1-1dd4baea85a9 (view SPL)0.25% Acetic Acid Irrigation USPprescriptionHuman PrescriptionB. Braun Medical Inc.2012-07-264002642304

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII