Isoflurane Inhalant Solution

Brand(s)
Forane, Terrell
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Baxter Healthcare Corporation (2011-12-15)
Oldest Current Product
2010-01-01
License(s)
NDA, ANDA
RxNORM
INHALANT SOLUTION\ISOFLURANE
FDAOB
INHALATION\LIQUID\ISOFLURANE\rdfq
SPL Active
RESPIRATORY (INHALATION)\INHALANT\ISOFLURANE
RESPIRATORY (INHALATION)\LIQUID\ISOFLURANE
SPL Moiety
RESPIRATORY (INHALATION)\INHALANT\ISOFLURANE
RESPIRATORY (INHALATION)\LIQUID\ISOFLURANE

product(s) by strength(s)

isoflurane 999 mg/ml inhalant solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1100190360ForaneNDABaxter Healthcare Corporation2011-08-08ISOFLURANERESPIRATORY (INHALATION)INHALANTNDA0176243d30eb8d-a62e-475f-926b-78ba63bee9c8

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1667940011TerrellANDAPiramal Critical Care Inc2010-01-01ISOFLURANERESPIRATORY (INHALATION)LIQUIDANDA074416dfb26527-c5ab-44d0-9236-24b1600e0db4
2667940017ANDAPiramal Critical Care Inc2011-10-07ISOFLURANERESPIRATORY (INHALATION)LIQUIDANDA074502d6851c71-0c2f-43f6-883c-a43fe894985d
3667940019TerrellANDAPiramal Critical Care Inc2012-03-21ISOFLURANERESPIRATORY (INHALATION)LIQUIDANDA074502dbeb646f-dc6c-40f2-803c-68858d6ac080
4667940020ANDAPiramal Critical Care Inc2013-11-13ISOFLURANERESPIRATORY (INHALATION)LIQUIDANDA07441613c9c37a-0c3d-450a-a61e-d2796818b18f

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA074097ISOFLURANEHOSPIRA INC1993-01-25ANDA074097_001
2ANDA074393ISOFLURANETrueWATSON LABORATORIES INC1995-05-12ANDA074393_001
3ANDA074416ISOFLURANEPIRAMAL CRITICAL CARE INC1994-09-30ANDA074416_001
4ANDA074502ISOFLURANEPIRAMAL ENTERPRISES LTD1995-06-27ANDA074502_001
5ANDA075225ISOFLURANEHALOCARBON PRODUCTS CORP1999-10-20ANDA075225_001
6NDA017624FORANEBAXTER HEALTHCARE CORPNDA017624_001

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA074097_001RXISOFLURANE (99.9%)LIQUIDFalseAN1993-01-25ISOFLURANE
2ANDA074393_001discontinuedISOFLURANE (99.9%)LIQUIDFalse1995-05-12ISOFLURANE
3ANDA074416_001RXISOFLURANE (99.9%)LIQUIDFalseAN1994-09-30ISOFLURANE
4ANDA074502_001RXISOFLURANE (99.9%)LIQUIDFalseAN1995-06-27ISOFLURANE
5ANDA075225_001RXISOFLURANE (99.9%)LIQUIDFalseAN1999-10-20ISOFLURANE
6NDA017624_001RXISOFLURANE (99.9%)LIQUIDTrueANFORANE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
113c9c37a-0c3d-450a-a61e-d2796818b18f (view SPL)Isoflurane, USP Generic-Piramal Critical CareprescriptionHuman PrescriptionPiramal Critical Care IncANALYSIS, API MANUFACTURE, LABEL, MANUFACTURE, PACK2015-03-032667940020
23d30eb8d-a62e-475f-926b-78ba63bee9c8 (view SPL)FORANE (isoflurane, USP)Liquid For InhalationRx onlyprescriptionHuman PrescriptionBaxter Healthcare CorporationMANUFACTURE2011-12-152100190360
3d6851c71-0c2f-43f6-883c-a43fe894985d (view SPL)Isoflurane USPprescriptionHuman PrescriptionPiramal Critical Care IncANALYSIS, API MANUFACTURE, MANUFACTURE, PACK2015-01-058667940017
4dbeb646f-dc6c-40f2-803c-68858d6ac080 (view SPL)TerrellprescriptionHuman PrescriptionPiramal Critical Care IncANALYSIS, API MANUFACTURE, MANUFACTURE, PACK2014-11-112667940019
5dfb26527-c5ab-44d0-9236-24b1600e0db4 (view SPL)prescriptionHuman PrescriptionPiramal Critical Care IncANALYSIS, API MANUFACTURE, LABEL, MANUFACTURE, PACK2015-02-136667940011

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