Cytarabine Injectable Solution

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Hospira Worldwide, Inc. (2015-04-20)
Oldest Current Product
1990-06-04
License(s)
ANDA
RxNORM
INJECTABLE SOLUTION\CYTARABINE
FDAOB
INJECTION\INJECTION\CYTARABINE\rdfq
SPL Active
INTRATHECAL\INJECTION, SOLUTION\CYTARABINE
INTRATHECAL\INJECTION\CYTARABINE
INTRAVENOUS\INJECTION, SOLUTION\CYTARABINE
INTRAVENOUS\INJECTION\CYTARABINE
SPL Moiety
INTRATHECAL\INJECTION, SOLUTION\CYTARABINE
INTRATHECAL\INJECTION\CYTARABINE
INTRAVENOUS\INJECTION, SOLUTION\CYTARABINE
INTRAVENOUS\INJECTION\CYTARABINE

product(s) by strength(s)

cytarabine 100 mg/ml injectable solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000690155ANDAPfizer Labs2012-01-31CYTARABINEINTRATHECALINJECTIONANDA201784b3965885-10e2-4d72-8f1c-a9f63c2d9ca7
2617030319ANDAHospira Worldwide, Inc.1999-11-22CYTARABINEINTRATHECALINJECTION, SOLUTIONANDA075383277597b0-7d85-40a3-a34a-70c6a883fc6d
3633230120ANDAApp Pharmaceuticals, Llc2004-11-29CYTARABINEINTRATHECALINJECTION, SOLUTIONANDA076512c4fdc56e-efd7-4825-a518-ef430b2b3df0
4674570452ANDAMylan Institutional Llc2012-01-31CYTARABINEINTRATHECALINJECTIONANDA20178434803a0e-f54d-4147-8f9f-7d0e3a007756
5674570615ANDAMylan Institutional Llc2012-01-31CYTARABINEINTRATHECALINJECTIONANDA2017849c5179ca-1a55-4e41-8994-ed0ce2489f34

cytarabine 20 mg/ml injectable solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000690152ANDAPfizer Labs2011-12-14CYTARABINEINTRATHECALINJECTIONANDA200915f4a9a667-48c9-409f-ad7b-4597e264fc46
2000690153ANDAPfizer Labs2011-12-14CYTARABINEINTRAVENOUSINJECTIONANDA2009161315f89d-f530-4dff-98e5-27d51617d4a1
3000690154ANDAPfizer Labs2011-12-14CYTARABINEINTRAVENOUSINJECTIONANDA200914715053ea-055d-4c47-8548-06aa0619ed3e
4617030303ANDAHospira Worldwide, Inc.1990-08-31CYTARABINEINTRAVENOUSINJECTION, SOLUTIONANDA072168681b5dc4-4fcf-4fab-ad78-02cb9a4a5dd0
5617030304ANDAHospira Worldwide, Inc.1994-02-28CYTARABINEINTRAVENOUSINJECTION, SOLUTIONANDA07294521e8e8e6-3f85-4fdd-8452-c9d14d2ef69a
6617030305ANDAHospira Worldwide, Inc.1990-06-04CYTARABINEINTRATHECALINJECTION, SOLUTIONANDA071868bc2fa221-ea56-48b8-8304-42cd81b8463b
7674570454ANDAMylan Institutional Llc2011-12-14CYTARABINEINTRAVENOUSINJECTIONANDA200914b48842dd-c5c9-484c-a3f5-cb883919b418
8674570455ANDAMylan Institutional Llc2011-12-14CYTARABINEINTRATHECALINJECTIONANDA200915ee6decae-7e1b-45cf-b2d0-c15946d8fa1f

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA071471CYTARABINEEUROHEALTH INTERNATIONAL SARL1989-08-02ANDA071471_001
2ANDA071472CYTARABINEEUROHEALTH INTERNATIONAL SARL1989-08-02ANDA071472_001
3ANDA071868CYTARABINEHOSPIRA INC1990-06-04ANDA071868_001
4ANDA072168CYTARABINEHOSPIRA INC1990-08-31ANDA072168_001
5ANDA072945CYTARABINEHOSPIRA INC1994-02-28ANDA072945_001
6ANDA074245CYTARABINEEUROHEALTH INTERNATIONAL SARL1994-08-31ANDA074245_001, ANDA074245_002
7ANDA075206CYTOSAR-UTEVA PHARMACEUTICALS USA1998-12-30ANDA075206_001, ANDA075206_002, ANDA075206_003, ANDA075206_004
8ANDA075383CYTARABINEHOSPIRA INC1999-11-22ANDA075383_001
9ANDA076512CYTARABINEFRESENIUS KABI USA LLC2004-01-15ANDA076512_001
10ANDA200914CYTARABINEMYLAN LABORATORIES LTD2011-12-13ANDA200914_001
11ANDA200915CYTARABINEMYLAN LABORATORIES LTD2011-12-13ANDA200915_001
12ANDA200916CYTARABINEMYLAN LABORATORIES LTD2011-12-13ANDA200916_001
13ANDA201784CYTARABINEMYLAN LABORATORIES LTD2012-01-30ANDA201784_001
14NDA016793CYTARABINETrueTEVA PARENTERAL MEDICINES INCNDA016793_001, NDA016793_002, NDA016793_003, NDA016793_004

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA071471_001RXCYTARABINE (100MG/VIAL)INJECTIONFalseAP1989-08-02CYTARABINE
2ANDA071472_001RXCYTARABINE (500MG/VIAL)INJECTIONFalseAP1989-08-02CYTARABINE
3ANDA071868_001RXCYTARABINE (20MG/ML)INJECTIONTrueAP1990-06-04CYTARABINE
4ANDA072168_001RXCYTARABINE (20MG/ML)INJECTIONTrueAP1990-08-31CYTARABINE
5ANDA072945_001RXCYTARABINE (20MG/ML)INJECTIONTrueAP1994-02-28CYTARABINE
6ANDA074245_001RXCYTARABINE (1GM/VIAL)INJECTIONFalseAP1994-08-31CYTARABINE
7ANDA074245_002RXCYTARABINE (2GM/VIAL)INJECTIONFalseAP1994-08-31CYTARABINE
8ANDA075206_001RXCYTARABINE (100MG/VIAL)INJECTIONFalseAP1998-12-30CYTOSAR-U
9ANDA075206_002RXCYTARABINE (500MG/VIAL)INJECTIONTrueAP1998-12-30CYTOSAR-U
10ANDA075206_003RXCYTARABINE (2GM/VIAL)INJECTIONTrueAP1998-12-30CYTOSAR-U
11ANDA075206_004RXCYTARABINE (1GM/VIAL)INJECTIONTrueAP1998-12-30CYTOSAR-U
12ANDA075383_001RXCYTARABINE (100MG/ML)INJECTIONFalseAP1999-11-22CYTARABINE
13ANDA076512_001RXCYTARABINE (100MG/ML)INJECTIONTrueAP2004-01-15CYTARABINE
14ANDA200914_001RXCYTARABINE (20MG/ML)INJECTIONFalseAP2011-12-13CYTARABINE
15ANDA200915_001RXCYTARABINE (20MG/ML)INJECTIONFalseAP2011-12-13CYTARABINE
16ANDA200916_001RXCYTARABINE (20MG/ML)INJECTIONFalseAP2011-12-13CYTARABINE
17ANDA201784_001RXCYTARABINE (100MG/ML)INJECTIONFalseAP2012-01-30CYTARABINE
18NDA016793_001discontinuedCYTARABINE (100MG/VIAL)INJECTIONFalseCYTARABINE
19NDA016793_002discontinuedCYTARABINE (500MG/VIAL)INJECTIONFalseCYTARABINE
20NDA016793_003discontinuedCYTARABINE (1GM/VIAL)INJECTIONFalse1987-12-21CYTARABINE
21NDA016793_004discontinuedCYTARABINE (2GM/VIAL)INJECTIONFalse1987-12-21CYTARABINE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
11315f89d-f530-4dff-98e5-27d51617d4a1 (view SPL)Cytarabine Injection 20mg/ml -25mlprescriptionHuman PrescriptionPfizer LabsAnalysis, Manufacture, Pack, Sterilize2012-04-201000690153
221e8e8e6-3f85-4fdd-8452-c9d14d2ef69a (view SPL)Cytarabine Injection Rx onlyprescriptionHuman PrescriptionHospira Worldwide, Inc.2015-04-145617030304
3277597b0-7d85-40a3-a34a-70c6a883fc6d (view SPL)Cytarabine InjectionRx onlyprescriptionHuman PrescriptionHospira Worldwide, Inc.2015-04-201617030319
434803a0e-f54d-4147-8f9f-7d0e3a007756 (view SPL)Cytarabine InjectionprescriptionHuman PrescriptionMylan Institutional LlcAnalysis, Label, Manufacture, Pack, Sterilize2014-02-131674570452
5681b5dc4-4fcf-4fab-ad78-02cb9a4a5dd0 (view SPL)Cytarabine InjectionRx onlyprescriptionHuman PrescriptionHospira Worldwide, Inc.2015-04-1412617030303
6715053ea-055d-4c47-8548-06aa0619ed3e (view SPL)Cytarabine Injection 50 mLprescriptionHuman PrescriptionPfizer LabsAnalysis, Manufacture, Pack, Sterilize2012-04-201000690154
79c5179ca-1a55-4e41-8994-ed0ce2489f34 (view SPL)Cytarabine InjectionprescriptionHuman PrescriptionMylan Institutional LlcANALYSIS, LABEL, MANUFACTURE, PACK, STERILIZE2014-12-151674570615
8b3965885-10e2-4d72-8f1c-a9f63c2d9ca7 (view SPL)Cytarabine InjectionprescriptionHuman PrescriptionPfizer LabsAnalysis, Manufacture, Pack, Sterilize2012-05-152000690155
9b48842dd-c5c9-484c-a3f5-cb883919b418 (view SPL)Cytarabine InjectionprescriptionHuman PrescriptionMylan Institutional LlcAnalysis, Label, Manufacture, Pack, Sterilize2014-09-261674570454
10bc2fa221-ea56-48b8-8304-42cd81b8463b (view SPL)Cytarabine InjectionRx onlyprescriptionHuman PrescriptionHospira Worldwide, Inc.2015-04-1412617030305
11c4fdc56e-efd7-4825-a518-ef430b2b3df0 (view SPL)Cytarabine InjectionprescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2012-08-201633230120
12ee6decae-7e1b-45cf-b2d0-c15946d8fa1f (view SPL)Cytarabine Injection 20 mg/mLprescriptionHuman PrescriptionMylan Institutional LlcANALYSIS, LABEL, MANUFACTURE, PACK, STERILIZE2015-01-131674570455
13f4a9a667-48c9-409f-ad7b-4597e264fc46 (view SPL)Cytarabine Injection - 20 mg/mLprescriptionHuman PrescriptionPfizer LabsAnalysis, Manufacture, Pack, Sterilize2012-04-201000690152

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