Haloperidol Oral Solution

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Teva Pharmaceuticals Usa Inc (2015-08-28)
Oldest Current Product
1988-12-01
License(s)
ANDA
RxNORM
ORAL SOLUTION\HALOPERIDOL
FDAOB
ORAL\CONCENTRATE\HALOPERIDOL LACTATE
SPL Active
ORAL\SOLUTION, CONCENTRATE\HALOPERIDOL
ORAL\SOLUTION, CONCENTRATE\HALOPERIDOL LACTATE
ORAL\SOLUTION\HALOPERIDOL
ORAL\SOLUTION\HALOPERIDOL LACTATE
SPL Moiety
ORAL\SOLUTION, CONCENTRATE\HALOPERIDOL
ORAL\SOLUTION\HALOPERIDOL

product(s) by strength(s)

haloperidol 2 mg/ml oral solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000939604ANDATeva Pharmaceuticals Usa Inc1988-12-01HALOPERIDOL LACTATEORALSOLUTION, CONCENTRATEANDA0716172d848e8c-de42-4a09-96f1-a2d250af059d
2001210581ANDAPharmaceutical Associates, Inc.2009-11-10HALOPERIDOLORALSOLUTION, CONCENTRATEANDA073037b488c106-f1ee-4b7b-8516-01162fb929f7
3006031290ANDAQualitest Pharmaceuticals1993-09-28HALOPERIDOLORALSOLUTIONANDA073364bbd719f1-3777-47bf-b1f8-8dd974d1769e
4548380501ANDASilarx Pharmaceuticals, Inc2009-09-08HALOPERIDOL LACTATEORALSOLUTIONANDA0733643e44fed0-6132-4881-a9cd-af6156c7af9c

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA070318HALOPERIDOLTrueALPHARMA USPD INC1986-04-11ANDA070318_001
2ANDA070710HALOPERIDOLTrueMORTON GROVE PHARMACEUTICALS INC1986-03-07ANDA070710_001
3ANDA070726HALOPERIDOLTrueSCS PHARMACEUTICALS1986-06-10ANDA070726_001
4ANDA071015HALOPERIDOLTrueTEVA PHARMACEUTICALS USA INC1987-08-25ANDA071015_001
5ANDA071617HALOPERIDOLTEVA PHARMACEUTICALS USA1988-12-01ANDA071617_001
6ANDA072045HALOPERIDOL INTENSOLTrueCYCLE PHARMACEUTICALS LTD1988-04-12ANDA072045_001
7ANDA073037HALOPERIDOLPHARMACEUTICAL ASSOC INC DIV BEACH PRODUCTS1993-02-26ANDA073037_001
8ANDA073364HALOPERIDOLSILARX PHARMACEUTICALS INC1993-09-28ANDA073364_001
9NDA015922HALDOLTrueORTHO MCNEIL PHARMACEUTICALNDA015922_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA070318_001discontinuedHALOPERIDOL LACTATE (EQ 2MG BASE/ML)ORALCONCENTRATEFalse1986-04-11HALOPERIDOL
2ANDA070710_001discontinuedHALOPERIDOL LACTATE (EQ 2MG BASE/ML)ORALCONCENTRATEFalse1986-03-07HALOPERIDOL
3ANDA070726_001discontinuedHALOPERIDOL LACTATE (EQ 2MG BASE/ML)ORALCONCENTRATEFalse1986-06-10HALOPERIDOL
4ANDA071015_001discontinuedHALOPERIDOL LACTATE (EQ 2MG BASE/ML)ORALCONCENTRATEFalse1987-08-25HALOPERIDOL
5ANDA071617_001RXHALOPERIDOL LACTATE (EQ 2MG BASE/ML)ORALCONCENTRATETrueAA1988-12-01HALOPERIDOL
6ANDA072045_001discontinuedHALOPERIDOL LACTATE (EQ 2MG BASE/ML)ORALCONCENTRATEFalse1988-04-12HALOPERIDOL INTENSOL
7ANDA073037_001RXHALOPERIDOL LACTATE (EQ 2MG BASE/ML)ORALCONCENTRATEFalseAA1993-02-26HALOPERIDOL
8ANDA073364_001RXHALOPERIDOL LACTATE (EQ 2MG BASE/ML)ORALCONCENTRATEFalseAA1993-09-28HALOPERIDOL
9NDA015922_001discontinuedHALOPERIDOL LACTATE (EQ 2MG BASE/ML)ORALCONCENTRATEFalseHALDOL

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
12d848e8c-de42-4a09-96f1-a2d250af059d (view SPL)HALOPERIDOL ORAL SOLUTION USP (CONCENTRATE)2 mg per mL 9604 Rx onlyprescriptionHuman PrescriptionTeva Pharmaceuticals Usa Inc2015-08-288000939604
23e44fed0-6132-4881-a9cd-af6156c7af9c (view SPL)Haloperidol Oral Solution USPprescriptionHuman PrescriptionSilarx Pharmaceuticals, Inc2014-06-2715548380501
3b488c106-f1ee-4b7b-8516-01162fb929f7 (view SPL)Haloperidol Oral Solution USP (Concentrate)prescriptionHuman PrescriptionPharmaceutical Associates, Inc.MANUFACTURE2010-09-134001210581
4bbd719f1-3777-47bf-b1f8-8dd974d1769e (view SPL)Haloperidol Oral Solution USPprescriptionHuman PrescriptionQualitest Pharmaceuticals2011-06-175006031290

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