Dipyridamole Injectable Solution

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
West-Ward Pharmaceuticals Corp. (2011-09-16)
Oldest Current Product
1996-10-18
License(s)
ANDA
RxNORM
INJECTABLE SOLUTION\DIPYRIDAMOLE
FDAOB
INJECTION\INJECTION\DIPYRIDAMOLE\rdfq
SPL Active
INTRAVENOUS\INJECTION, SOLUTION\DIPYRIDAMOLE
INTRAVENOUS\INJECTION\DIPYRIDAMOLE
SPL Moiety
INTRAVENOUS\INJECTION, SOLUTION\DIPYRIDAMOLE
INTRAVENOUS\INJECTION\DIPYRIDAMOLE

product(s) by strength(s)

dipyridamole 5 mg/ml injectable solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1006412569ANDAWest-Ward Pharmaceuticals Corp.1996-10-18DIPYRIDAMOLEINTRAVENOUSINJECTIONANDA0745216093dcd9-82d2-414f-8507-eda22c14f626

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1525840569ANDAGeneral Injecatables & Vaccines, Inc2010-09-01DIPYRIDAMOLEINTRAVENOUSINJECTION, SOLUTION006412569ANDA07452102e40b4e-80bb-4456-9d16-6f8a2f7ec5f0

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA074521DIPYRIDAMOLEEUROHEALTH INTERNATIONAL SARL1996-10-18ANDA074521_001
2ANDA074601DIPYRIDAMOLETrueHOSPIRA WORLDWIDE, INC1997-12-19ANDA074601_001
3ANDA074939DIPYRIDAMOLEBEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC1998-04-13ANDA074939_001
4ANDA074952DIPYRIDAMOLETrueTEVA PHARMACEUTICALS USA1997-11-26ANDA074952_001
5ANDA074956DIPYRIDAMOLEFRESENIUS KABI USA LLC1998-09-30ANDA074956_001
6ANDA075769DIPYRIDAMOLETrueMYLAN LABORATORIES LTD2002-11-27ANDA075769_001
7NDA019817IV PERSANTINETrueBOEHRINGER INGELHEIM PHARMACEUTICALS INC1990-12-13NDA019817_001

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA074521_001RXDIPYRIDAMOLE (5MG/ML)INJECTIONFalseAP1996-10-18DIPYRIDAMOLE
2ANDA074601_001discontinuedDIPYRIDAMOLE (5MG/ML)INJECTIONFalse1997-12-19DIPYRIDAMOLE
3ANDA074939_001RXDIPYRIDAMOLE (5MG/ML)INJECTIONTrueAP1998-04-13DIPYRIDAMOLE
4ANDA074952_001discontinuedDIPYRIDAMOLE (5MG/ML)INJECTIONFalse1997-11-26DIPYRIDAMOLE
5ANDA074956_001RXDIPYRIDAMOLE (5MG/ML)INJECTIONFalseAP1998-09-30DIPYRIDAMOLE
6ANDA075769_001discontinuedDIPYRIDAMOLE (5MG/ML)INJECTIONFalse2002-11-27DIPYRIDAMOLE
7NDA019817_001discontinuedDIPYRIDAMOLE (5MG/ML)INJECTIONFalse1990-12-13IV PERSANTINE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
102e40b4e-80bb-4456-9d16-6f8a2f7ec5f0 (view SPL)Dipyridamole 5 mg/mL Injection, USP 10 mL Single Dose VialprescriptionHuman PrescriptionGeneral Injecatables & Vaccines, Inc2012-02-082525840569
26093dcd9-82d2-414f-8507-eda22c14f626 (view SPL)Dipyridamole Injection, USPRx onlyprescriptionHuman PrescriptionWest-Ward Pharmaceuticals Corp.MANUFACTURE2011-09-165006412569

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