Hydralazine Injectable Solution

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Akorn (2013-02-21)
Oldest Current Product
1997-06-30
License(s)
ANDA
RxNORM
INJECTABLE SOLUTION\HYDRALAZINE
FDAOB
INJECTION\INJECTION\HYDRALAZINE HYDROCHLORIDE\rdfq
ORAL\TABLET\HYDRALAZINE HYDROCHLORIDE
SPL Active
INTRAMUSCULAR\INJECTION, SOLUTION\HYDRALAZINE HYDROCHLORIDE
INTRAMUSCULAR\INJECTION\HYDRALAZINE HYDROCHLORIDE
SPL Moiety
INTRAMUSCULAR\INJECTION, SOLUTION\HYDRALAZINE
INTRAMUSCULAR\INJECTION\HYDRALAZINE

product(s) by strength(s)

hydralazine hydrochloride 20 mg/ml injectable solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005170901ANDAAmerican Regent, Inc.1997-06-30HYDRALAZINE HYDROCHLORIDEINTRAMUSCULARINJECTION, SOLUTIONANDA04013617210abc-58f6-442e-8ff2-7971333c82f6
2174780834ANDAAkorn2013-02-21HYDRALAZINE HYDROCHLORIDEINTRAMUSCULARINJECTIONANDA040730638a511d-cb51-49b5-b917-ffe8192cc270
3174780934ANDAAkorn2009-05-01HYDRALAZINE HYDROCHLORIDEINTRAMUSCULARINJECTIONANDA040730e31239e0-8c5a-4d10-9404-af32278484a3
4398220500ANDAX-Gen Pharmaceuticals, Inc.2015-06-29HYDRALAZINE HYDROCHLORIDEINTRAMUSCULARINJECTION, SOLUTIONANDA2031103df38b75-b561-48c4-8e47-6ebfbfbd25ba
5633230614ANDAApp Pharmaceuticals, Llc2001-09-05, 2011-01-31HYDRALAZINE HYDROCHLORIDEINTRAMUSCULARINJECTIONANDA0403888223c44a-73a9-4da5-a468-d1d8bdb0bbd6, c3797028-c625-4f70-ae69-8a5f6f23f1b8, f34904dc-c945-4de4-8594-34e4f4ac1983

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1525840614ANDAGeneral Injecatables & Vaccines, Inc2011-10-19HYDRALAZINE HYDROCHLORIDEINTRAMUSCULARINJECTION, SOLUTION633230614ANDA0403885df975a6-04bd-4eb9-b1e1-90cd7d06f06b
2525840901ANDAGeneral Injecatables & Vaccines, Inc2010-08-01HYDRALAZINE HYDROCHLORIDEINTRAMUSCULARINJECTION, SOLUTION005170901ANDA0401364924a3a0-58c6-4f28-8e72-8a4fc6de055c
3548686266ANDAPhysicians Total Care, Inc.2011-05-17HYDRALAZINE HYDROCHLORIDEINTRAMUSCULARINJECTION, SOLUTION174780934ANDA04073004b4c1c2-093c-4f48-a6b4-3e290fae51b4
4551541278ANDACardinal Health2009-05-01HYDRALAZINE HYDROCHLORIDEINTRAMUSCULARINJECTION174780934ANDA04073040231804-35ea-4f3f-9a0c-33929f9d8ed1
5551541280ANDACardinal Health2009-05-01HYDRALAZINE HYDROCHLORIDEINTRAMUSCULARINJECTION174780934ANDA040730e992b777-4ff5-4cc2-ad8d-70971738b585
6551545719ANDACardinal Health1997-06-30HYDRALAZINE HYDROCHLORIDEINTRAMUSCULARINJECTION, SOLUTION005170901ANDA040136218c002d-283b-4008-bc38-365cfd53830d
7551549367ANDACardinal Health2011-01-31HYDRALAZINE HYDROCHLORIDEINTRAMUSCULARINJECTION633230614ANDA0403888fef436a-e71c-4c17-b0d1-4a6142bb035a
8551549554ANDACardinal Health2011-01-31HYDRALAZINE HYDROCHLORIDEINTRAMUSCULARINJECTION633230614ANDA04038843ce0ecb-6d62-44bf-8539-823ae03eb9f4

application(s)

#idtitledeprecatedapplicantapprovedapproved drugin other drug docs
1ANDA040136HYDRALAZINE HYDROCHLORIDELUITPOLD PHARMACEUTICALS INC1997-06-30ANDA040136_001
2ANDA040373HYDRALAZINE HYDROCHLORIDETrueTEVA PARENTERAL MEDICINES INC2000-02-23ANDA040373_001
3ANDA040388HYDRALAZINE HYDROCHLORIDEFRESENIUS KABI USA LLC2001-03-13ANDA040388_001
4ANDA040730HYDRALAZINE HYDROCHLORIDEAKORN INC2009-04-21ANDA040730_001
5ANDA088517HYDRALAZINE HYDROCHLORIDETrueSOLOPAK LABORATORIES INC1985-08-22ANDA088517_001
6ANDA088518HYDRALAZINE HYDROCHLORIDETrueSMITH AND NEPHEW SOLOPAK DIV SMITH AND NEPHEW1984-04-20ANDA088518_001
7ANDA089532HYDRALAZINE HYDROCHLORIDETrueABRAXIS PHARMACEUTICAL PRODUCTS1987-08-11ANDA089532_001
8ANDA202938HYDRALAZINE HYDROCHLORIDENAVINTA LLC2013-03-28ANDA202938_001
9ANDA203110HYDRALAZINE HYDROCHLORIDEX-GEN PHARMACEUTICALS INC2015-06-29ANDA203110_001
10NDA008303APRESOLINETrueNOVARTIS PHARMACEUTICALS CORPNDA008303_001, NDA008303_002, NDA008303_003, NDA008303_004, NDA008303_005Hydralazine Oral Tablet

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA040136_001RXHYDRALAZINE HYDROCHLORIDE (20MG/ML)INJECTIONFalseAP1997-06-30HYDRALAZINE HYDROCHLORIDE
2ANDA040373_001discontinuedHYDRALAZINE HYDROCHLORIDE (20MG/ML)INJECTIONFalse2000-02-23HYDRALAZINE HYDROCHLORIDE
3ANDA040388_001RXHYDRALAZINE HYDROCHLORIDE (20MG/ML)INJECTIONFalseAP2001-03-13HYDRALAZINE HYDROCHLORIDE
4ANDA040730_001RXHYDRALAZINE HYDROCHLORIDE (20MG/ML)INJECTIONTrueAP2009-04-21HYDRALAZINE HYDROCHLORIDE
5ANDA088517_001discontinuedHYDRALAZINE HYDROCHLORIDE (20MG/ML)INJECTIONFalse1985-08-22HYDRALAZINE HYDROCHLORIDE
6ANDA088518_001discontinuedHYDRALAZINE HYDROCHLORIDE (20MG/ML)INJECTIONFalse1984-04-20HYDRALAZINE HYDROCHLORIDE
7ANDA089532_001discontinuedHYDRALAZINE HYDROCHLORIDE (20MG/ML)INJECTIONFalse1987-08-11HYDRALAZINE HYDROCHLORIDE
8ANDA202938_001RXHYDRALAZINE HYDROCHLORIDE (20MG/ML)INJECTIONFalseAP2013-03-28HYDRALAZINE HYDROCHLORIDE
9ANDA203110_001RXHYDRALAZINE HYDROCHLORIDE (20MG/ML)INJECTIONFalseAP2015-06-29HYDRALAZINE HYDROCHLORIDE
10NDA008303_001discontinuedHYDRALAZINE HYDROCHLORIDE (25MG)ORALTABLETFalseAPRESOLINE
11NDA008303_002discontinuedHYDRALAZINE HYDROCHLORIDE (50MG)ORALTABLETFalseAPRESOLINE
12NDA008303_003discontinuedHYDRALAZINE HYDROCHLORIDE (20MG/ML)INJECTIONFalseAPRESOLINE
13NDA008303_004discontinuedHYDRALAZINE HYDROCHLORIDE (10MG)ORALTABLETFalseAPRESOLINE
14NDA008303_005discontinuedHYDRALAZINE HYDROCHLORIDE (100MG)ORALTABLETFalseAPRESOLINE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
104b4c1c2-093c-4f48-a6b4-3e290fae51b4 (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2011-06-161548686266
217210abc-58f6-442e-8ff2-7971333c82f6 (view SPL)Hydralazine Hydrochloride Injection, USPprescriptionHuman PrescriptionAmerican Regent, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK, STERILIZE2013-09-095005170901
3218c002d-283b-4008-bc38-365cfd53830d (view SPL)Hydralazine Hydrochloride Injection, USPprescriptionHuman PrescriptionCardinal HealthREPACK2012-04-271551545719
43df38b75-b561-48c4-8e47-6ebfbfbd25ba (view SPL)Hydralazine Hydrochloride Injection, USPprescriptionHuman PrescriptionX-Gen Pharmaceuticals, Inc.2014-10-083398220500
540231804-35ea-4f3f-9a0c-33929f9d8ed1 (view SPL)HydrALAZINE Hydrochloride InjectionprescriptionHuman PrescriptionCardinal HealthREPACK2013-10-162551541278
643ce0ecb-6d62-44bf-8539-823ae03eb9f4 (view SPL)Hydralazine Hydrochloride Injection USPprescriptionHuman PrescriptionCardinal HealthREPACK2014-05-124551549554
74924a3a0-58c6-4f28-8e72-8a4fc6de055c (view SPL)Hydralazine Hydrochloride 20 mg/mL Injection, USP 1 mL Single Dose VialprescriptionHuman PrescriptionGeneral Injecatables & Vaccines, Inc2010-09-031525840901
85df975a6-04bd-4eb9-b1e1-90cd7d06f06b (view SPL)Hydralazine HCL 20mg/mL 1mL single dose vialprescriptionHuman PrescriptionGeneral Injecatables & Vaccines, Inc2014-04-292525840614
9638a511d-cb51-49b5-b917-ffe8192cc270 (view SPL)HydrALAZINE Hydrochloride Injection, USPprescriptionHuman PrescriptionAkornANALYSIS, LABEL, MANUFACTURE, PACK, STERILIZE2013-02-211174780834
108223c44a-73a9-4da5-a468-d1d8bdb0bbd6 (view SPL)Hydralazine Hydrochloride Injection, USPprescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2015-06-0110633230614
118fef436a-e71c-4c17-b0d1-4a6142bb035a (view SPL)Hydralazine HydrochlorideprescriptionHuman PrescriptionCardinal HealthREPACK2014-08-052551549367
12c3797028-c625-4f70-ae69-8a5f6f23f1b8 (view SPL)Hydralazine Hydrochloride Injection USPprescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2015-07-223633230614
13e31239e0-8c5a-4d10-9404-af32278484a3 (view SPL)HydrALAZINE Hydrochloride InjectionprescriptionHuman PrescriptionAkornANALYSIS, LABEL, MANUFACTURE, PACK, RELABEL, REPACK, STERILIZE2012-03-235174780934
14e992b777-4ff5-4cc2-ad8d-70971738b585 (view SPL)HydrALAZINE Hydrochloride InjectionprescriptionHuman PrescriptionCardinal HealthREPACK2013-05-151551541280
15f34904dc-c945-4de4-8594-34e4f4ac1983 (view SPL)Hydralazine Hydrochloride Injection USPprescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2013-12-182633230614

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