Fluphenazine Injectable Solution

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Par Pharmaceutical Inc. (2014-12-15)
Oldest Current Product
2010-12-15
License(s)
ANDA
RxNORM
INJECTABLE SOLUTION\FLUPHENAZINE
FDAOB
INJECTION\INJECTION\FLUPHENAZINE DECANOATE\rdfq
INJECTION\INJECTION\FLUPHENAZINE HYDROCHLORIDE\rdfq
ORAL\TABLET\FLUPHENAZINE HYDROCHLORIDE
SPL Active
INTRAMUSCULAR\INJECTION, SOLUTION\FLUPHENAZINE DECANOATE
INTRAMUSCULAR\INJECTION, SOLUTION\FLUPHENAZINE HYDROCHLORIDE
SPL Moiety
INTRAMUSCULAR\INJECTION, SOLUTION\FLUPHENAZINE
INTRAMUSCULAR\INJECTION, SOLUTION\FLUPHENAZINE DECANOATE

product(s) by strength(s)

fluphenazine hydrochloride 2.5 mg/ml injectable solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1633230281ANDAApp Pharmaceuticals, Llc2010-12-28FLUPHENAZINE HYDROCHLORIDEINTRAMUSCULARINJECTION, SOLUTIONANDA089556d571f04f-6190-42f2-932c-5a075fd978b9

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1647252810ANDATya Pharmaceuticals2010-12-28FLUPHENAZINE HYDROCHLORIDEINTRAMUSCULARINJECTION, SOLUTION633230281ANDA0895562a8ef5f7-c806-470d-96ff-3b3827dc8938

fluphenazine decanoate 25 mg/ml injectable solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1420230129ANDAPar Pharmaceutical Inc.2014-07-09FLUPHENAZINE DECANOATEINTRAMUSCULARINJECTION, SOLUTIONANDA203732b580471f-44a1-4da0-96ad-2f537eabec3e
2633230272ANDAApp Pharmaceuticals, Llc2010-12-15FLUPHENAZINE DECANOATEINTRAMUSCULARINJECTION, SOLUTIONANDA071413f8ba014e-aea0-49bc-8345-4e0a384b484e

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1647250272ANDATya Pharmaceuticals2010-12-15FLUPHENAZINE DECANOATEINTRAMUSCULARINJECTION, SOLUTION633230272ANDA07141373d85626-abf8-493a-bb8c-ce9a4f2ae08b

application(s)

#idtitledeprecatedapplicantapprovedapproved drugin other drug docs
1ANDA071413FLUPHENAZINE DECANOATEFRESENIUS KABI USA LLC1987-07-14ANDA071413_001
2ANDA074531FLUPHENAZINE DECANOATEEUROHEALTH INTERNATIONAL SARL1996-08-30ANDA074531_001
3ANDA074795FLUPHENAZINE DECANOATETrueTEVA PARENTERAL MEDICINES INC1996-09-10ANDA074795_001
4ANDA074966FLUPHENAZINE DECANOATETrueHOSPIRA INC1998-04-16ANDA074966_001
5ANDA075918FLUPHENAZINE DECANOATETrueMYLAN LABORATORIES LTD2001-08-17ANDA075918_001
6ANDA089556FLUPHENAZINE HYDROCHLORIDEFRESENIUS KABI USA LLC1987-04-16ANDA089556_001
7ANDA203732FLUPHENAZINE DECANOATEPAR STERILE PRODUCTS LLC2014-07-03ANDA203732_001
8NDA011751PROLIXINTrueAPOTHECON INC DIV BRISTOL MYERS SQUIBBNDA011751_001, NDA011751_002, NDA011751_003, NDA011751_004, NDA011751_005Fluphenazine Oral Tablet
9NDA016727PROLIXIN DECANOATETrueBRISTOL MYERS SQUIBB CONDA016727_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA071413_001RXFLUPHENAZINE DECANOATE (25MG/ML)INJECTIONTrueAO1987-07-14FLUPHENAZINE DECANOATE
2ANDA074531_001RXFLUPHENAZINE DECANOATE (25MG/ML)INJECTIONFalseAO1996-08-30FLUPHENAZINE DECANOATE
3ANDA074795_001discontinuedFLUPHENAZINE DECANOATE (25MG/ML)INJECTIONFalse1996-09-10FLUPHENAZINE DECANOATE
4ANDA074966_001discontinuedFLUPHENAZINE DECANOATE (25MG/ML)INJECTIONFalse1998-04-16FLUPHENAZINE DECANOATE
5ANDA075918_001discontinuedFLUPHENAZINE DECANOATE (25MG/ML)INJECTIONFalse2001-08-17FLUPHENAZINE DECANOATE
6ANDA089556_001RXFLUPHENAZINE HYDROCHLORIDE (2.5MG/ML)INJECTIONTrue1987-04-16FLUPHENAZINE HYDROCHLORIDE
7ANDA203732_001RXFLUPHENAZINE DECANOATE (25MG/ML)INJECTIONFalseAO2014-07-03FLUPHENAZINE DECANOATE
8NDA011751_001discontinuedFLUPHENAZINE HYDROCHLORIDE (2.5MG)ORALTABLETFalsePROLIXIN
9NDA011751_002discontinuedFLUPHENAZINE HYDROCHLORIDE (10MG)ORALTABLETFalsePROLIXIN
10NDA011751_003discontinuedFLUPHENAZINE HYDROCHLORIDE (5MG)ORALTABLETFalsePROLIXIN
11NDA011751_004discontinuedFLUPHENAZINE HYDROCHLORIDE (1MG)ORALTABLETFalsePROLIXIN
12NDA011751_005discontinuedFLUPHENAZINE HYDROCHLORIDE (2.5MG/ML)INJECTIONFalsePROLIXIN
13NDA016727_001discontinuedFLUPHENAZINE DECANOATE (25MG/ML)INJECTIONFalsePROLIXIN DECANOATE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
12a8ef5f7-c806-470d-96ff-3b3827dc8938 (view SPL)prescriptionHuman PrescriptionTya PharmaceuticalsRELABEL, REPACK2011-01-042647252810
273d85626-abf8-493a-bb8c-ce9a4f2ae08b (view SPL)Fluphenazine Decanoate Injection, USPprescriptionHuman PrescriptionTya PharmaceuticalsRELABEL, REPACK2010-12-162647250272
3b580471f-44a1-4da0-96ad-2f537eabec3e (view SPL)Fluphenazine Decanoate Injection, USPprescriptionHuman PrescriptionPar Pharmaceutical Inc.2014-12-153420230129
4d571f04f-6190-42f2-932c-5a075fd978b9 (view SPL)prescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2011-01-041633230281
5f8ba014e-aea0-49bc-8345-4e0a384b484e (view SPL)Fluphenazine Decanoate Injection, USPprescriptionHuman PrescriptionApp Pharmaceuticals, LlcMANUFACTURE2010-12-161633230272

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