Glycine Irrigation Solution

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
B. Braun Medical Inc. (2014-09-30)
Oldest Current Product
1978-02-06
License(s)
NDA
RxNORM
IRRIGATION SOLUTION\GLYCINE
FDAOB
IRRIGATION\SOLUTION\GLYCINE
SPL Active
IRRIGATION\IRRIGANT\GLYCINE
SPL Moiety
IRRIGATION\IRRIGANT\GLYCINE

product(s) by strength(s)

glycine 15 mg/ml irrigation solution

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1002642302NDAB. Braun Medical Inc.1978-02-06GLYCINEIRRIGATIONIRRIGANTNDA0167845751bfda-7cad-43e7-955d-4a850541575b
2002647390NDAB. Braun Medical Inc.2013-12-04GLYCINEIRRIGATIONIRRIGANTNDA016784f4d83550-42de-44c7-b8d5-1d0debc6aec2

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1NDA016784GLYCINE 1.5% IN PLASTIC CONTAINERB BRAUN MEDICAL INCNDA016784_001
2NDA017633GLYCINE 1.5% IN PLASTIC CONTAINERTrueHOSPIRA INCNDA017633_001
3NDA017865AMINOACETIC ACID 1.5% IN PLASTIC CONTAINERBAXTER HEALTHCARE CORPNDA017865_001
4NDA018315GLYCINE 1.5% IN PLASTIC CONTAINERHOSPIRA INCNDA018315_001
5NDA018522GLYCINE 1.5% IN PLASTIC CONTAINERTrueBAXTER HEALTHCARE CORP1982-02-19NDA018522_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1NDA016784_001RXGLYCINE (1.5GM/100ML)IRRIGATIONSOLUTIONFalseATGLYCINE 1.5% IN PLASTIC CONTAINER
2NDA017633_001discontinuedGLYCINE (1.5GM/100ML)IRRIGATIONSOLUTIONFalseGLYCINE 1.5% IN PLASTIC CONTAINER
3NDA017865_001RXGLYCINE (1.5GM/100ML)IRRIGATIONSOLUTIONFalseATAMINOACETIC ACID 1.5% IN PLASTIC CONTAINER
4NDA018315_001RXGLYCINE (1.5GM/100ML)IRRIGATIONSOLUTIONFalseATGLYCINE 1.5% IN PLASTIC CONTAINER
5NDA018522_001discontinuedGLYCINE (1.5GM/100ML)IRRIGATIONSOLUTIONFalse1982-02-19GLYCINE 1.5% IN PLASTIC CONTAINER

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
15751bfda-7cad-43e7-955d-4a850541575b (view SPL)1.5% Glycine Irrigation USPprescriptionHuman PrescriptionB. Braun Medical Inc.2012-02-235002642302
2ac04939e-7641-48e6-31b3-1e6c897b5f60 (view SPL)1.5% GLYCINE IRRIGATION, USPprescriptionHuman PrescriptionHospira, Inc.2014-03-0613004097974
3d4665408-04d8-4ad7-8589-708d4defb869 (view SPL)1.5% Glycine Irrigation, USP in UROMATIC Plastic ContainerprescriptionHuman PrescriptionBaxter Healthcare CorporationANALYSIS, LABEL, MANUFACTURE, PACK, STERILIZE2014-07-233003380289
4f4d83550-42de-44c7-b8d5-1d0debc6aec2 (view SPL)1.5% Glycine Irrigation USPprescriptionHuman PrescriptionB. Braun Medical Inc.2014-09-304002647390

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