Prochlorperazine Injectable Solution

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
West-Ward Pharmaceuticals Corp. (2015-11-13)
Oldest Current Product
1989-08-29
License(s)
ANDA
RxNORM
INJECTABLE SOLUTION\PROCHLORPERAZINE
FDAOB
INJECTION\INJECTION\PROCHLORPERAZINE EDISYLATE\rdfq
SPL Active
INTRAMUSCULAR\INJECTION\PROCHLORPERAZINE EDISYLATE
SPL Moiety
INTRAMUSCULAR\INJECTION\PROCHLORPERAZINE

product(s) by strength(s)

prochlorperazine 5 mg/ml injectable solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1006410491ANDAWest-Ward Pharmaceuticals Corp.2011-01-14PROCHLORPERAZINE EDISYLATEINTRAMUSCULARINJECTIONANDA0899035e771ba7-983f-49b4-a1f2-0f335b637433
2006416135ANDAWest-Ward Pharmaceuticals Corp.1989-08-29PROCHLORPERAZINE EDISYLATEINTRAMUSCULARINJECTIONANDA089903baf59816-7577-4652-b065-fb6de9e54569
3231550294ANDAHeritage Pharmaceuticals Inc.2012-03-26PROCHLORPERAZINE EDISYLATEINTRAMUSCULARINJECTIONANDA2041470dc48e66-6081-421b-952b-4867c9c4c794
4231550497ANDAHeritage Pharmaceuticals Inc.2015-01-14PROCHLORPERAZINE EDISYLATEINTRAMUSCULARINJECTIONANDA204147328bcba6-a2f8-4216-8f6f-c40959fe8779
5231550523ANDAHeritage Pharmaceuticals Inc.2015-06-26PROCHLORPERAZINE EDISYLATEINTRAMUSCULARINJECTIONANDA2041470338b221-db43-45c9-a829-d970fe6643ab

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1525840077ANDAGeneral Injecatables & Vaccines, Inc2010-08-01PROCHLORPERAZINE EDISYLATEINTRAMUSCULARINJECTION553900077ANDA040540daabf2ee-7f0e-4b45-a2be-8ab6d8c9d3e7
2548680261ANDAPhysicians Total Care, Inc.2004-07-26PROCHLORPERAZINE EDISYLATEINTRAMUSCULARINJECTION553900077ANDA040540016b4aa0-ec8f-4bbc-aa07-58e3da801c3b
3551540370ANDACardinal Health2004-07-26PROCHLORPERAZINE EDISYLATEINTRAMUSCULARINJECTION553900077ANDA040540a0e65883-9d67-4569-af69-b6ab7ee4a536
4551544183ANDACardinal Health2012-03-26PROCHLORPERAZINE EDISYLATEINTRAMUSCULARINJECTION231550294ANDA2041476135944c-3ee2-4491-9704-33f56ad435f4
5617860219ANDARemedyrepack Inc.2015-03-12PROCHLORPERAZINE EDISYLATEINTRAMUSCULARINJECTION231550294ANDA204147479dc389-1b0a-4de4-b20e-d537cda326aa

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA040505PROCHLORPERAZINE EDISYLATETrueTEVA PARENTERAL MEDICINES INC2003-05-30ANDA040505_001
2ANDA040540PROCHLORPERAZINE EDISYLATEBEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC2004-05-28ANDA040540_001
3ANDA086348PROCHLORPERAZINE EDISYLATETrueWYETH AYERST LABORATORIESANDA086348_001
4ANDA087759PROCHLORPERAZINETrueBAXTER HEALTHCARE CORP ANESTHESIA AND CRITICAL CARE1982-10-01ANDA087759_001
5ANDA089251PROCHLORPERAZINE EDISYLATETrueSMITH AND NEPHEW SOLOPAK DIV SMITH AND NEPHEW1986-12-04ANDA089251_001
6ANDA089523PROCHLORPERAZINE EDISYLATETrueHIKMA MAPLE LTD1988-05-03ANDA089523_001
7ANDA089530PROCHLORPERAZINE EDISYLATETrueWATSON LABORATORIES INC1987-07-08ANDA089530_001
8ANDA089605PROCHLORPERAZINE EDISYLATETrueWATSON LABORATORIES INC1987-07-08ANDA089605_001
9ANDA089606PROCHLORPERAZINE EDISYLATETrueWATSON LABORATORIES INC1987-07-08ANDA089606_001
10ANDA089675PROCHLORPERAZINE EDISYLATETrueMARSAM PHARMACEUTICALS LLC1988-12-05ANDA089675_001
11ANDA089703PROCHLORPERAZINE EDISYLATETrueHOSPIRA INC1988-04-07ANDA089703_001
12ANDA089903PROCHLORPERAZINE EDISYLATEEUROHEALTH INTERNATIONAL SARL1989-08-29ANDA089903_001
13ANDA204147PROCHLORPERAZINE EDISYLATEEMCURE PHARMACEUTICALS LTD2013-10-15ANDA204147_001
14NDA010742COMPAZINETrueGLAXOSMITHKLINENDA010742_002

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA040505_001discontinuedPROCHLORPERAZINE EDISYLATE (EQ 5MG BASE/ML)INJECTIONFalse2003-05-30PROCHLORPERAZINE EDISYLATE
2ANDA040540_001RXPROCHLORPERAZINE EDISYLATE (EQ 5MG BASE/ML)INJECTIONFalseAP2004-05-28PROCHLORPERAZINE EDISYLATE
3ANDA086348_001discontinuedPROCHLORPERAZINE EDISYLATE (EQ 5MG BASE/ML)INJECTIONFalsePROCHLORPERAZINE EDISYLATE
4ANDA087759_001discontinuedPROCHLORPERAZINE EDISYLATE (EQ 5MG BASE/ML)INJECTIONFalse1982-10-01PROCHLORPERAZINE
5ANDA089251_001discontinuedPROCHLORPERAZINE EDISYLATE (EQ 5MG BASE/ML)INJECTIONFalse1986-12-04PROCHLORPERAZINE EDISYLATE
6ANDA089523_001discontinuedPROCHLORPERAZINE EDISYLATE (EQ 5MG BASE/ML)INJECTIONFalse1988-05-03PROCHLORPERAZINE EDISYLATE
7ANDA089530_001discontinuedPROCHLORPERAZINE EDISYLATE (EQ 5MG BASE/ML)INJECTIONFalse1987-07-08PROCHLORPERAZINE EDISYLATE
8ANDA089605_001discontinuedPROCHLORPERAZINE EDISYLATE (EQ 5MG BASE/ML)INJECTIONFalse1987-07-08PROCHLORPERAZINE EDISYLATE
9ANDA089606_001discontinuedPROCHLORPERAZINE EDISYLATE (EQ 5MG BASE/ML)INJECTIONFalse1987-07-08PROCHLORPERAZINE EDISYLATE
10ANDA089675_001discontinuedPROCHLORPERAZINE EDISYLATE (EQ 5MG BASE/ML)INJECTIONFalse1988-12-05PROCHLORPERAZINE EDISYLATE
11ANDA089703_001discontinuedPROCHLORPERAZINE EDISYLATE (EQ 5MG BASE/ML)INJECTIONFalse1988-04-07PROCHLORPERAZINE EDISYLATE
12ANDA089903_001RXPROCHLORPERAZINE EDISYLATE (EQ 5MG BASE/ML)INJECTIONTrueAP1989-08-29PROCHLORPERAZINE EDISYLATE
13ANDA204147_001RXPROCHLORPERAZINE EDISYLATE (EQ 5MG BASE/ML)INJECTIONFalseAP2013-10-15PROCHLORPERAZINE EDISYLATE
14NDA010742_002discontinuedPROCHLORPERAZINE EDISYLATE (EQ 5MG BASE/ML)INJECTIONFalseCOMPAZINE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1016b4aa0-ec8f-4bbc-aa07-58e3da801c3b (view SPL)PROCHLORPERAZINE EDISYLATE INJECTION USPprescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2010-04-211548680261
20338b221-db43-45c9-a829-d970fe6643ab (view SPL)Rx onlyprescriptionHuman PrescriptionHeritage Pharmaceuticals Inc.analysis, label, manufacture, pack2015-06-261231550523
30dc48e66-6081-421b-952b-4867c9c4c794 (view SPL)Rx onlyprescriptionHuman PrescriptionHeritage Pharmaceuticals Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2013-11-154231550294
4328bcba6-a2f8-4216-8f6f-c40959fe8779 (view SPL)Rx onlyprescriptionHuman PrescriptionHeritage Pharmaceuticals Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2015-01-201231550497
5479dc389-1b0a-4de4-b20e-d537cda326aa (view SPL)Rx onlyprescriptionHuman PrescriptionRemedyrepack Inc.2015-03-121617860219
65e771ba7-983f-49b4-a1f2-0f335b637433 (view SPL)Prochlorperazine Edisylate Injection, USPRx onlyprescriptionHuman PrescriptionWest-Ward Pharmaceuticals Corp.MANUFACTURE2011-01-043006410491
76135944c-3ee2-4491-9704-33f56ad435f4 (view SPL)Rx onlyprescriptionHuman PrescriptionCardinal HealthREPACK2015-10-011551544183
8a0e65883-9d67-4569-af69-b6ab7ee4a536 (view SPL)PROCHLORPERAZINE EDISYLATE INJECTION, USPprescriptionHuman PrescriptionCardinal HealthREPACK2014-09-303551540370
9baf59816-7577-4652-b065-fb6de9e54569 (view SPL)Prochlorperazine Edisylate Injection, USPprescriptionHuman PrescriptionWest-Ward Pharmaceuticals Corp.ANALYSIS, LABEL, MANUFACTURE, PACK2015-11-132006416135
10daabf2ee-7f0e-4b45-a2be-8ab6d8c9d3e7 (view SPL)Prochlorperazine Edisylate 10 mg/2mL Injection, USP 2 mL VialprescriptionHuman PrescriptionGeneral Injecatables & Vaccines, Inc2010-08-251525840077

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