Haloperidol Injectable Solution

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Sagent Pharmaceuticals (2015-06-30)
Oldest Current Product
1999-07-01
License(s)
ANDA
RxNORM
INJECTABLE SOLUTION\HALOPERIDOL
FDAOB
INJECTION\INJECTION\HALOPERIDOL DECANOATE\rdfq
INJECTION\INJECTION\HALOPERIDOL LACTATE\rdfq
SPL Active
INTRAMUSCULAR\INJECTION, SOLUTION\HALOPERIDOL LACTATE
INTRAMUSCULAR\INJECTION\HALOPERIDOL DECANOATE
INTRAMUSCULAR\INJECTION\HALOPERIDOL LACTATE
SPL Moiety
INTRAMUSCULAR\INJECTION, SOLUTION\HALOPERIDOL
INTRAMUSCULAR\INJECTION\HALOPERIDOL

product(s) by strength(s)

haloperidol 5 mg/ml injectable solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1007037045ANDATeva Parenteral Medicines, Inc2002-03-01HALOPERIDOL LACTATEINTRAMUSCULARINJECTIONANDA0760352a541687-12e1-4ccf-ad4d-8aa29b4a9de4
2250210823ANDASagent Pharmaceuticals2011-10-24HALOPERIDOL LACTATEINTRAMUSCULARINJECTION, SOLUTIONANDA2007427ce7f23c-f58b-4b8b-a31a-47bd4e792345

haloperidol decanoate 100 mg/ml injectable solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1007037023ANDATeva Parenteral Medicines, Inc1999-07-01HALOPERIDOL DECANOATEINTRAMUSCULARINJECTIONANDA0753935632ada4-05bd-4638-a27a-81d37a66a084
2531500489ANDAAmneal-Agila, Llc2013-04-23HALOPERIDOL DECANOATEINTRAMUSCULARINJECTIONANDA075440754b7218-29e0-49df-b929-c79a6e121763

haloperidol decanoate 50 mg/ml injectable solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1007037013ANDATeva Parenteral Medicines, Inc1999-07-01HALOPERIDOL DECANOATEINTRAMUSCULARINJECTIONANDA0753935632ada4-05bd-4638-a27a-81d37a66a084
2531500422ANDAAmneal-Agila, Llc2013-04-23HALOPERIDOL DECANOATEINTRAMUSCULARINJECTIONANDA075440754b7218-29e0-49df-b929-c79a6e121763

application(s)

#idtitledeprecatedapplicantapprovedapproved drugin other drug docs
1ANDA070713HALOPERIDOLTrueWATSON LABORATORIES INC1988-05-17ANDA070713_001Haloperidol Injection
2ANDA070714HALOPERIDOLTrueWATSON LABORATORIES INC1988-05-17ANDA070714_001Haloperidol Injection
3ANDA070744HALOPERIDOLTrueWATSON LABORATORIES INC1988-05-17ANDA070744_001Haloperidol Injection
4ANDA070800HALOPERIDOLTrueSOLOPAK MEDICAL PRODUCTS INC1987-12-14ANDA070800_001Haloperidol Injection
5ANDA070801HALOPERIDOLTrueSOLOPAK LABORATORIES INC1987-12-14ANDA070801_001Haloperidol Injection
6ANDA070802HALOPERIDOLTrueSMITH AND NEPHEW SOLOPAK DIV SMITH AND NEPHEW1987-12-14ANDA070802_001Haloperidol Injection
7ANDA070864HALOPERIDOLTrueSOLOPAK LABORATORIES INC1987-12-14ANDA070864_001Haloperidol Injection
8ANDA071187HALOPERIDOLTrueABRAXIS PHARMACEUTICAL PRODUCTS1987-01-20ANDA071187_001Haloperidol Injection
9ANDA072516HALOPERIDOLTrueMARSAM PHARMACEUTICALS LLC1993-02-25ANDA072516_001Haloperidol Injection
10ANDA072517HALOPERIDOLTrueMARSAM PHARMACEUTICALS LLC1993-02-25ANDA072517_001Haloperidol Injection
11ANDA074811HALOPERIDOL DECANOATEEUROHEALTH INTERNATIONAL SARL1998-01-30ANDA074811_001Haloperidol Injection
12ANDA074893HALOPERIDOL DECANOATEFRESENIUS KABI USA LLC1997-12-19ANDA074893_001, ANDA074893_002Haloperidol Injection
13ANDA075176HALOPERIDOL DECANOATETrueHOSPIRA INC2000-02-09ANDA075176_001, ANDA075176_002Haloperidol Injection
14ANDA075305HALOPERIDOL DECANOATEEUROHEALTH INTERNATIONAL SARL1998-09-28ANDA075305_001Haloperidol Injection
15ANDA075393HALOPERIDOL DECANOATETEVA PHARMACEUTICALS USA1999-05-11ANDA075393_001, ANDA075393_002Haloperidol Injection
16ANDA075440HALOPERIDOL DECANOATEMYLAN LABORATORIES LTD2000-02-28ANDA075440_001, ANDA075440_002Haloperidol Injection
17ANDA075689HALOPERIDOLFRESENIUS KABI USA LLC2001-03-09ANDA075689_001Haloperidol Injection
18ANDA075858HALOPERIDOLEUROHEALTH INTERNATIONAL SARL2001-06-18ANDA075858_001Haloperidol Injection
19ANDA076035HALOPERIDOLTEVA PHARMACEUTICALS USA2001-08-29ANDA076035_001Haloperidol Injection
20ANDA076463HALOPERIDOL DECANOATETrueSANDOZ CANADA INC2005-06-24ANDA076463_001, ANDA076463_002Haloperidol Injection
21ANDA076464HALOPERIDOLTrueSANDOZ CANADA INC2004-09-29ANDA076464_001Haloperidol Injection
22ANDA076774HALOPERIDOLGLAND PHARMA LTD2004-08-25ANDA076774_001Haloperidol Injection
23ANDA076791HALOPERIDOLTrueCLARIS PHARMASERVICES2004-08-25ANDA076791_001Haloperidol Injection
24ANDA076828HALOPERIDOLTrueCLARIS PHARMASERVICES2004-08-25ANDA076828_001Haloperidol Injection
25ANDA078347HALOPERIDOLMYLAN LABORATORIES LTD2009-09-14ANDA078347_001Haloperidol Injection
26ANDA091637HALOPERIDOLSAGENT PHARMACEUTICALS INC2011-09-02ANDA091637_001Haloperidol Injection
27ANDA200742HALOPERIDOLSAGENT PHARMACEUTICALS INC2011-09-02ANDA200742_001Haloperidol Injection
28NDA015923HALDOLJANSSEN PHARMACEUTICALS INCNDA015923_001Haloperidol Injection
29NDA018701HALDOLJANSSEN PHARMACEUTICALS INC1986-01-14NDA018701_001, NDA018701_002Haloperidol Injection

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA070713_001discontinuedHALOPERIDOL LACTATE (EQ 5MG BASE/ML)INJECTIONFalse1988-05-17HALOPERIDOL
2ANDA070714_001discontinuedHALOPERIDOL LACTATE (EQ 5MG BASE/ML)INJECTIONFalse1988-05-17HALOPERIDOL
3ANDA070744_001discontinuedHALOPERIDOL LACTATE (EQ 5MG BASE/ML)INJECTIONFalse1988-05-17HALOPERIDOL
4ANDA070800_001discontinuedHALOPERIDOL LACTATE (EQ 5MG BASE/ML)INJECTIONFalse1987-12-14HALOPERIDOL
5ANDA070801_001discontinuedHALOPERIDOL LACTATE (EQ 5MG BASE/ML)INJECTIONFalse1987-12-14HALOPERIDOL
6ANDA070802_001discontinuedHALOPERIDOL LACTATE (EQ 5MG BASE/ML)INJECTIONFalse1987-12-14HALOPERIDOL
7ANDA070864_001discontinuedHALOPERIDOL LACTATE (EQ 5MG BASE/ML)INJECTIONFalse1987-12-14HALOPERIDOL
8ANDA071187_001discontinuedHALOPERIDOL LACTATE (EQ 5MG BASE/ML)INJECTIONFalse1987-01-20HALOPERIDOL
9ANDA072516_001discontinuedHALOPERIDOL LACTATE (EQ 5MG BASE/ML)INJECTIONFalse1993-02-25HALOPERIDOL
10ANDA072517_001discontinuedHALOPERIDOL LACTATE (EQ 5MG BASE/ML)INJECTIONFalse1993-02-25HALOPERIDOL
11ANDA074811_001RXHALOPERIDOL DECANOATE (EQ 50MG BASE/ML)INJECTIONFalseAO1998-01-30HALOPERIDOL DECANOATE
12ANDA074893_001RXHALOPERIDOL DECANOATE (EQ 50MG BASE/ML)INJECTIONFalseAO1997-12-19HALOPERIDOL DECANOATE
13ANDA074893_002RXHALOPERIDOL DECANOATE (EQ 100MG BASE/ML)INJECTIONFalseAO1997-12-19HALOPERIDOL DECANOATE
14ANDA075176_001discontinuedHALOPERIDOL DECANOATE (EQ 50MG BASE/ML)INJECTIONFalse2000-02-09HALOPERIDOL DECANOATE
15ANDA075176_002discontinuedHALOPERIDOL DECANOATE (EQ 100MG BASE/ML)INJECTIONFalse2000-02-09HALOPERIDOL DECANOATE
16ANDA075305_001RXHALOPERIDOL DECANOATE (EQ 100MG BASE/ML)INJECTIONFalseAO1998-09-28HALOPERIDOL DECANOATE
17ANDA075393_001RXHALOPERIDOL DECANOATE (EQ 50MG BASE/ML)INJECTIONFalseAO1999-05-11HALOPERIDOL DECANOATE
18ANDA075393_002RXHALOPERIDOL DECANOATE (EQ 100MG BASE/ML)INJECTIONFalseAO1999-05-11HALOPERIDOL DECANOATE
19ANDA075440_001RXHALOPERIDOL DECANOATE (EQ 50MG BASE/ML)INJECTIONFalseAO2000-02-28HALOPERIDOL DECANOATE
20ANDA075440_002RXHALOPERIDOL DECANOATE (EQ 100MG BASE/ML)INJECTIONFalseAO2000-02-28HALOPERIDOL DECANOATE
21ANDA075689_001RXHALOPERIDOL LACTATE (EQ 5MG BASE/ML)INJECTIONFalseAP2001-03-09HALOPERIDOL
22ANDA075858_001RXHALOPERIDOL LACTATE (EQ 5MG BASE/ML)INJECTIONFalseAP2001-06-18HALOPERIDOL
23ANDA076035_001RXHALOPERIDOL LACTATE (EQ 5MG BASE/ML)INJECTIONFalseAP2001-08-29HALOPERIDOL
24ANDA076463_001discontinuedHALOPERIDOL DECANOATE (EQ 50MG BASE/ML)INJECTIONFalse2005-06-24HALOPERIDOL DECANOATE
25ANDA076463_002discontinuedHALOPERIDOL DECANOATE (EQ 100MG BASE/ML)INJECTIONFalse2005-06-24HALOPERIDOL DECANOATE
26ANDA076464_001discontinuedHALOPERIDOL LACTATE (EQ 5MG BASE/ML)INJECTIONFalse2004-09-29HALOPERIDOL
27ANDA076774_001RXHALOPERIDOL LACTATE (EQ 5MG BASE/ML)INJECTIONFalseAP2004-08-25HALOPERIDOL
28ANDA076791_001discontinuedHALOPERIDOL LACTATE (EQ 5MG BASE/ML)INJECTIONFalse2004-08-25HALOPERIDOL
29ANDA076828_001discontinuedHALOPERIDOL LACTATE (EQ 5MG BASE/ML)INJECTIONFalse2004-08-25HALOPERIDOL
30ANDA078347_001RXHALOPERIDOL LACTATE (EQ 5MG BASE/ML)INJECTIONFalseAP2009-09-14HALOPERIDOL
31ANDA091637_001RXHALOPERIDOL LACTATE (EQ 5MG BASE/ML)INJECTIONFalseAP2011-09-02HALOPERIDOL
32ANDA200742_001RXHALOPERIDOL LACTATE (EQ 5MG BASE/ML)INJECTIONFalseAP2011-09-02HALOPERIDOL
33NDA015923_001RXHALOPERIDOL LACTATE (EQ 5MG BASE/ML)INJECTIONTrueAPHALDOL
34NDA018701_001RXHALOPERIDOL DECANOATE (EQ 50MG BASE/ML)INJECTIONTrueAO1986-01-14HALDOL
35NDA018701_002RXHALOPERIDOL DECANOATE (EQ 100MG BASE/ML)INJECTIONTrueAO1997-01-31HALDOL

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
12a541687-12e1-4ccf-ad4d-8aa29b4a9de4 (view SPL)Haloperidol Injection USP (For Immediate Release)prescriptionHuman PrescriptionTeva Parenteral Medicines, Inc2015-07-139007037045, 007037041Haloperidol Injection
25632ada4-05bd-4638-a27a-81d37a66a084 (view SPL)Haloperidol Decanoate InjectionprescriptionHuman PrescriptionTeva Parenteral Medicines, Inc2015-08-188007037013, 007037023, 007037011, 007037021Haloperidol Injection
3754b7218-29e0-49df-b929-c79a6e121763 (view SPL)HALOPERIDOL DECANOATE INJECTION 50 mg/mL HALOPERIDOL DECANOATE INJECTION 100 mg/mL For IM Injection Only RX ONLYprescriptionHuman PrescriptionAmneal-Agila, LlcANALYSIS, MANUFACTURE, PACK, STERILIZE2013-01-311531500422, 531500489, 531500415, 531500485Haloperidol Injection
47ce7f23c-f58b-4b8b-a31a-47bd4e792345 (view SPL)Haloperidol Injection, USP(For Immediate Release)(For Intramuscular Use)prescriptionHuman PrescriptionSagent Pharmaceuticals2015-06-308250210823, 250210806Haloperidol Injection

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