Prochlorperazine Rectal Suppository

Brand(s)
Compazine, Compro
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
G&W Laboratories, Inc. (2008-12-18)
Oldest Current Product
1993-11-30
License(s)
ANDA
RxNORM
RECTAL SUPPOSITORY\PROCHLORPERAZINE
FDAOB
RECTAL\SUPPOSITORY\PROCHLORPERAZINE
SPL Active
RECTAL\SUPPOSITORY\PROCHLORPERAZINE
SPL Moiety
RECTAL\SUPPOSITORY\PROCHLORPERAZINE

product(s) by strength(s)

prochlorperazine 25 mg rectal suppository

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005747226ComproANDAPaddock Laboratories, Llc2000-09-01PROCHLORPERAZINERECTALSUPPOSITORYANDA040246ea381bc5-0957-4c91-826a-0ff680cebacc
2007130135ANDAG&W Laboratories, Inc.1993-11-30PROCHLORPERAZINERECTALSUPPOSITORYANDA0400589595346e-76e5-e155-341b-ffaaafb885ab
3662130200CompazineANDAPbm Pharmaceuticals, Inc2013-07-01PROCHLORPERAZINERECTALSUPPOSITORYANDA0402469bdba30b-53b4-427a-af74-7a39b52130b2

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548683112ANDAPhysicians Total Care, Inc.2001-07-20PROCHLORPERAZINERECTALSUPPOSITORY007130315ANDA04005899d9e8a9-e299-4ee4-9f04-a82a83845594
2552890119ComproANDAPd-Rx Pharmaceuticals, Inc.2000-09-01PROCHLORPERAZINERECTALSUPPOSITORY005747226ANDA040246b23b67eb-78b7-48eb-84ff-c95d3ce8683c

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA040058PROCHLORPERAZINEG AND W LABORATORIES INC1993-11-24ANDA040058_001
2ANDA040246COMPROPADDOCK LABORATORIES LLC2000-06-28ANDA040246_001
3ANDA040407PROCHLORPERAZINETrueABLE LABORATORIES INC2001-07-11ANDA040407_001, ANDA040407_002, ANDA040407_003
4NDA011127COMPAZINETrueGLAXOSMITHKLINENDA011127_001, NDA011127_002, NDA011127_003

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA040058_001RXPROCHLORPERAZINE (25MG)RECTALSUPPOSITORYTrueAB1993-11-24PROCHLORPERAZINE
2ANDA040246_001RXPROCHLORPERAZINE (25MG)RECTALSUPPOSITORYFalseAB2000-06-28COMPRO
3ANDA040407_001discontinuedPROCHLORPERAZINE (2.5MG)RECTALSUPPOSITORYFalse2001-07-11PROCHLORPERAZINE
4ANDA040407_002discontinuedPROCHLORPERAZINE (5MG)RECTALSUPPOSITORYFalse2001-07-11PROCHLORPERAZINE
5ANDA040407_003discontinuedPROCHLORPERAZINE (25MG)RECTALSUPPOSITORYFalse2001-07-11PROCHLORPERAZINE
6NDA011127_001discontinuedPROCHLORPERAZINE (5MG)RECTALSUPPOSITORYFalseCOMPAZINE
7NDA011127_002discontinuedPROCHLORPERAZINE (25MG)RECTALSUPPOSITORYFalseCOMPAZINE
8NDA011127_003discontinuedPROCHLORPERAZINE (2.5MG)RECTALSUPPOSITORYFalseCOMPAZINE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
19595346e-76e5-e155-341b-ffaaafb885ab (view SPL)PROCHLORPERAZINE SUPPOSITORIES, USPprescriptionHuman PrescriptionG&W Laboratories, Inc.MANUFACTURE2008-12-184007130135
299d9e8a9-e299-4ee4-9f04-a82a83845594 (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2010-08-091548683112
39bdba30b-53b4-427a-af74-7a39b52130b2 (view SPL)Drug FactsCompazineProchlorperazine Suppositories USPprescriptionHuman PrescriptionPbm Pharmaceuticals, Inc2013-08-284662130200
4b23b67eb-78b7-48eb-84ff-c95d3ce8683c (view SPL)COMPRO PROCHLORPERAZINE SUPPOSITORIES USP, 25mgprescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2010-12-225552890119
5ea381bc5-0957-4c91-826a-0ff680cebacc (view SPL)PRESCRIBING INFORMATION COMPRO PROCHLORPERAZINE SUPPOSITORIES USP, 25 mg Rx onlyprescriptionHuman PrescriptionPaddock Laboratories, Llc2014-08-206005747226

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