Fluphenazine Oral Tablet

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Mylan Institutional Inc. (2013-02-01)
Oldest Current Product
1987-10-16
License(s)
ANDA
RxNORM
ORAL TABLET\FLUPHENAZINE
FDAOB
INJECTION\INJECTION\FLUPHENAZINE HYDROCHLORIDE\rdfq
ORAL\TABLET\FLUPHENAZINE HYDROCHLORIDE
SPL Active
ORAL\TABLET, FILM COATED\FLUPHENAZINE HYDROCHLORIDE
ORAL\TABLET\FLUPHENAZINE HYDROCHLORIDE
SPL Moiety
ORAL\TABLET, FILM COATED\FLUPHENAZINE
ORAL\TABLET\FLUPHENAZINE

product(s) by strength(s)

fluphenazine hydrochloride 1 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003786004ANDAMylan Pharmaceuticals Inc.1988-08-12FLUPHENAZINE HYDROCHLORIDEORALTABLET, FILM COATEDANDA08980433bffb02-f1cc-4554-a3b7-9f2291feb4ac
2005271788ANDALannett Company, Inc.2010-09-27FLUPHENAZINE HYDROCHLORIDEORALTABLET, FILM COATEDANDA0897406cd6ba35-3481-48c1-87db-dc74ce9d7d75
3007811436ANDASandoz Inc1987-10-16FLUPHENAZINE HYDROCHLORIDEORALTABLET, FILM COATEDANDA089586e2cfc2bf-8916-4e34-9a25-79efd74d00d1
4510790485ANDAMylan Institutional Inc.1998-04-30FLUPHENAZINE HYDROCHLORIDEORALTABLET, FILM COATEDANDA089804a61e5bf9-b545-43e9-9f20-cdcb31abda91

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1493490005ANDARemedyrepack Inc.2011-08-02FLUPHENAZINE HYDROCHLORIDEORALTABLET003786004ANDA089804b20e1d8a-1040-48ad-b0d5-adf1fa18e6e9
2493490369ANDARemedyrepack Inc.2011-07-11FLUPHENAZINE HYDROCHLORIDEORALTABLET007811436ANDA089583e235e2ea-9d09-426f-8849-468302aee1ae
3581181436ANDAClinical Solutions Wholesale1987-10-16FLUPHENAZINE HYDROCHLORIDEORALTABLET, FILM COATED007811436ANDA089586bd9c7abe-ad50-4409-b841-e60b1ee5e915

fluphenazine hydrochloride 10 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003786097ANDAMylan Pharmaceuticals Inc.1988-08-12FLUPHENAZINE HYDROCHLORIDEORALTABLET, FILM COATEDANDA08980433bffb02-f1cc-4554-a3b7-9f2291feb4ac
2005271791ANDALannett Company, Inc.2010-09-27FLUPHENAZINE HYDROCHLORIDEORALTABLET, FILM COATEDANDA0897436cd6ba35-3481-48c1-87db-dc74ce9d7d75
3007811439ANDASandoz Inc1987-10-16FLUPHENAZINE HYDROCHLORIDEORALTABLET, FILM COATEDANDA089586e2cfc2bf-8916-4e34-9a25-79efd74d00d1
4510790488ANDAMylan Institutional Inc.1998-07-15FLUPHENAZINE HYDROCHLORIDEORALTABLET, FILM COATEDANDA089804a61e5bf9-b545-43e9-9f20-cdcb31abda91

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1006153574ANDANcs Healthcare Of Ky, Inc Dba Vangard Labs1988-08-12FLUPHENAZINE HYDROCHLORIDEORALTABLET, FILM COATED003786097ANDA0898043f70d690-8f53-4bbf-94f4-003ade36eacf
2493490189ANDARemedyrepack Inc.2010-12-23FLUPHENAZINE HYDROCHLORIDEORALTABLET, FILM COATED003786097ANDA08980426d6bc24-7ed7-4690-81f8-072da76e5199
3521250694ANDARemedyrepack Inc.2013-09-26FLUPHENAZINE HYDROCHLORIDEORALTABLET, FILM COATED007811439ANDA0895864ff01dd0-0322-4761-a7d7-bd0e19958316
4538080600ANDAState Of Florida Doh Central Pharmacy2009-07-01FLUPHENAZINE HYDROCHLORIDEORALTABLET, FILM COATED003786097ANDA08980469b5a8a7-03b1-41ad-b1ed-f922e3ab4bdd
5581181439ANDAClinical Solutions Wholesale1987-10-16FLUPHENAZINE HYDROCHLORIDEORALTABLET, FILM COATED007811439ANDA089586bd9c7abe-ad50-4409-b841-e60b1ee5e915
6680840950ANDAAmerican Health Packaging2015-03-31FLUPHENAZINE HYDROCHLORIDEORALTABLET, FILM COATED005271791ANDA089743653b9cc3-dd87-427e-80f5-1c73bc764393

fluphenazine hydrochloride 2.5 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003786009ANDAMylan Pharmaceuticals Inc.1988-08-12FLUPHENAZINE HYDROCHLORIDEORALTABLET, FILM COATEDANDA08980433bffb02-f1cc-4554-a3b7-9f2291feb4ac
2005271789ANDALannett Company, Inc.2010-09-27FLUPHENAZINE HYDROCHLORIDEORALTABLET, FILM COATEDANDA0897416cd6ba35-3481-48c1-87db-dc74ce9d7d75
3007811437ANDASandoz Inc1987-10-16FLUPHENAZINE HYDROCHLORIDEORALTABLET, FILM COATEDANDA089586e2cfc2bf-8916-4e34-9a25-79efd74d00d1
4510790486ANDAMylan Institutional Inc.1998-06-02FLUPHENAZINE HYDROCHLORIDEORALTABLET, FILM COATEDANDA089804a61e5bf9-b545-43e9-9f20-cdcb31abda91

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1493490279ANDARemedyrepack Inc.2011-06-03FLUPHENAZINE HYDROCHLORIDEORALTABLET007811437ANDA08958437a7fed7-d9b2-4c92-bfa6-986e1eef8ebe
2581181437ANDAClinical Solutions Wholesale1987-10-16FLUPHENAZINE HYDROCHLORIDEORALTABLET, FILM COATED007811437ANDA089586bd9c7abe-ad50-4409-b841-e60b1ee5e915

fluphenazine hydrochloride 5 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003786074ANDAMylan Pharmaceuticals Inc.1988-08-12FLUPHENAZINE HYDROCHLORIDEORALTABLET, FILM COATEDANDA08980433bffb02-f1cc-4554-a3b7-9f2291feb4ac
2005271790ANDALannett Company, Inc.2010-09-27FLUPHENAZINE HYDROCHLORIDEORALTABLET, FILM COATEDANDA0897426cd6ba35-3481-48c1-87db-dc74ce9d7d75
3007811438ANDASandoz Inc1987-10-16FLUPHENAZINE HYDROCHLORIDEORALTABLET, FILM COATEDANDA089586e2cfc2bf-8916-4e34-9a25-79efd74d00d1
4510790487ANDAMylan Institutional Inc.1998-06-04FLUPHENAZINE HYDROCHLORIDEORALTABLET, FILM COATEDANDA089804a61e5bf9-b545-43e9-9f20-cdcb31abda91

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1006151501ANDANcs Healthcare Of Ky, Inc Dba Vangard Labs1988-08-12FLUPHENAZINE HYDROCHLORIDEORALTABLET, FILM COATED003786074ANDA0898043f70d690-8f53-4bbf-94f4-003ade36eacf
2493490354ANDARemedyrepack Inc.2010-12-23FLUPHENAZINE HYDROCHLORIDEORALTABLET, FILM COATED003786074ANDA0898040dd24d38-a421-4337-a423-b4e459e570af
3493490598ANDARemedyrepack Inc.2011-10-25FLUPHENAZINE HYDROCHLORIDEORALTABLET007811438ANDA089585c11bd5c4-0c84-4ce8-ab91-a4fb2d1bf203
4538080247ANDAState Of Florida Doh Central Pharmacy2009-07-01FLUPHENAZINE HYDROCHLORIDEORALTABLET, FILM COATED003786074ANDA08980469b5a8a7-03b1-41ad-b1ed-f922e3ab4bdd
5581181438ANDAClinical Solutions Wholesale1987-10-16FLUPHENAZINE HYDROCHLORIDEORALTABLET, FILM COATED007811438ANDA089586bd9c7abe-ad50-4409-b841-e60b1ee5e915
6647251438ANDATya Pharmaceuticals1987-10-16FLUPHENAZINE HYDROCHLORIDEORALTABLET, FILM COATED007811438ANDA08958650c7e742-1165-4c45-bbf6-172cf70a387a
7680840846ANDAAmerican Health Packaging2014-10-13FLUPHENAZINE HYDROCHLORIDEORALTABLET, FILM COATED005271790ANDA089742653b9cc3-dd87-427e-80f5-1c73bc764393

application(s)

#idtitledeprecatedapplicantapprovedapproved drugin other drug docs
1ANDA088527FLUPHENAZINE HYDROCHLORIDETrueWATSON LABORATORIES INC1987-12-18ANDA088527_001
2ANDA088544FLUPHENAZINE HYDROCHLORIDETrueWATSON LABORATORIES INC1987-12-18ANDA088544_001
3ANDA088550FLUPHENAZINE HYDROCHLORIDETrueWATSON LABORATORIES INC1987-12-18ANDA088550_001
4ANDA088555FLUPHENAZINE HYDROCHLORIDETrueWATSON LABORATORIES INC1987-12-18ANDA088555_001
5ANDA089583FLUPHENAZINE HYDROCHLORIDESANDOZ INC1987-10-16ANDA089583_001
6ANDA089584FLUPHENAZINE HYDROCHLORIDESANDOZ INC1987-10-16ANDA089584_001
7ANDA089585FLUPHENAZINE HYDROCHLORIDESANDOZ INC1987-10-16ANDA089585_001
8ANDA089586FLUPHENAZINE HYDROCHLORIDESANDOZ INC1987-10-16ANDA089586_001
9ANDA089740FLUPHENAZINE HYDROCHLORIDELANNETT HOLDINGS INC1988-08-25ANDA089740_001
10ANDA089741FLUPHENAZINE HYDROCHLORIDELANNETT HOLDINGS INC1988-08-25ANDA089741_001
11ANDA089742FLUPHENAZINE HYDROCHLORIDELANNETT HOLDINGS INC1988-08-25ANDA089742_001
12ANDA089743FLUPHENAZINE HYDROCHLORIDELANNETT HOLDINGS INC1988-08-25ANDA089743_001
13ANDA089804FLUPHENAZINE HYDROCHLORIDEMYLAN PHARMACEUTICALS INC1988-08-12ANDA089804_001, ANDA089804_002, ANDA089804_003, ANDA089804_004
14NDA011751PROLIXINTrueAPOTHECON INC DIV BRISTOL MYERS SQUIBBNDA011751_001, NDA011751_002, NDA011751_003, NDA011751_004, NDA011751_005Fluphenazine Injectable Solution
15NDA012034PERMITILTrueSCHERING CORP SUB SCHERING PLOUGH CORPNDA012034_001, NDA012034_004, NDA012034_005, NDA012034_006

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA088527_001discontinuedFLUPHENAZINE HYDROCHLORIDE (5MG)ORALTABLETFalse1987-12-18FLUPHENAZINE HYDROCHLORIDE
2ANDA088544_001discontinuedFLUPHENAZINE HYDROCHLORIDE (2.5MG)ORALTABLETFalse1987-12-18FLUPHENAZINE HYDROCHLORIDE
3ANDA088550_001discontinuedFLUPHENAZINE HYDROCHLORIDE (10MG)ORALTABLETFalse1987-12-18FLUPHENAZINE HYDROCHLORIDE
4ANDA088555_001discontinuedFLUPHENAZINE HYDROCHLORIDE (1MG)ORALTABLETFalse1987-12-18FLUPHENAZINE HYDROCHLORIDE
5ANDA089583_001RXFLUPHENAZINE HYDROCHLORIDE (1MG)ORALTABLETFalseAB1987-10-16FLUPHENAZINE HYDROCHLORIDE
6ANDA089584_001RXFLUPHENAZINE HYDROCHLORIDE (2.5MG)ORALTABLETFalseAB1987-10-16FLUPHENAZINE HYDROCHLORIDE
7ANDA089585_001RXFLUPHENAZINE HYDROCHLORIDE (5MG)ORALTABLETFalseAB1987-10-16FLUPHENAZINE HYDROCHLORIDE
8ANDA089586_001RXFLUPHENAZINE HYDROCHLORIDE (10MG)ORALTABLETFalseAB1987-10-16FLUPHENAZINE HYDROCHLORIDE
9ANDA089740_001RXFLUPHENAZINE HYDROCHLORIDE (1MG)ORALTABLETFalseAB1988-08-25FLUPHENAZINE HYDROCHLORIDE
10ANDA089741_001RXFLUPHENAZINE HYDROCHLORIDE (2.5MG)ORALTABLETFalseAB1988-08-25FLUPHENAZINE HYDROCHLORIDE
11ANDA089742_001RXFLUPHENAZINE HYDROCHLORIDE (5MG)ORALTABLETFalseAB1988-08-25FLUPHENAZINE HYDROCHLORIDE
12ANDA089743_001RXFLUPHENAZINE HYDROCHLORIDE (10MG)ORALTABLETFalseAB1988-08-25FLUPHENAZINE HYDROCHLORIDE
13ANDA089804_001RXFLUPHENAZINE HYDROCHLORIDE (10MG)ORALTABLETTrueAB1988-08-12FLUPHENAZINE HYDROCHLORIDE
14ANDA089804_002RXFLUPHENAZINE HYDROCHLORIDE (1MG)ORALTABLETFalseAB1988-08-12FLUPHENAZINE HYDROCHLORIDE
15ANDA089804_003RXFLUPHENAZINE HYDROCHLORIDE (2.5MG)ORALTABLETFalseAB1988-08-12FLUPHENAZINE HYDROCHLORIDE
16ANDA089804_004RXFLUPHENAZINE HYDROCHLORIDE (5MG)ORALTABLETFalseAB1988-08-12FLUPHENAZINE HYDROCHLORIDE
17NDA011751_001discontinuedFLUPHENAZINE HYDROCHLORIDE (2.5MG)ORALTABLETFalsePROLIXIN
18NDA011751_002discontinuedFLUPHENAZINE HYDROCHLORIDE (10MG)ORALTABLETFalsePROLIXIN
19NDA011751_003discontinuedFLUPHENAZINE HYDROCHLORIDE (5MG)ORALTABLETFalsePROLIXIN
20NDA011751_004discontinuedFLUPHENAZINE HYDROCHLORIDE (1MG)ORALTABLETFalsePROLIXIN
21NDA011751_005discontinuedFLUPHENAZINE HYDROCHLORIDE (2.5MG/ML)INJECTIONFalsePROLIXIN
22NDA012034_001discontinuedFLUPHENAZINE HYDROCHLORIDE (0.25MG)ORALTABLETFalsePERMITIL
23NDA012034_004discontinuedFLUPHENAZINE HYDROCHLORIDE (2.5MG)ORALTABLETFalsePERMITIL
24NDA012034_005discontinuedFLUPHENAZINE HYDROCHLORIDE (5MG)ORALTABLETFalsePERMITIL
25NDA012034_006discontinuedFLUPHENAZINE HYDROCHLORIDE (10MG)ORALTABLETFalsePERMITIL

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
10dd24d38-a421-4337-a423-b4e459e570af (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2010-12-23164493490354
226d6bc24-7ed7-4690-81f8-072da76e5199 (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2010-12-23168493490189
333bffb02-f1cc-4554-a3b7-9f2291feb4ac (view SPL)prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2010-09-165003786004, 003786009, 003786074, 003786097
437a7fed7-d9b2-4c92-bfa6-986e1eef8ebe (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2011-06-031493490279
53f70d690-8f53-4bbf-94f4-003ade36eacf (view SPL)FLUPHENAZINE HYDROCHLORIDE TABLETS, USP1 mg, 2.5 mg, 5 mg and 10 mgprescriptionHuman PrescriptionNcs Healthcare Of Ky, Inc Dba Vangard LabsRELABEL, REPACK2010-05-121006151501, 006153574
64ff01dd0-0322-4761-a7d7-bd0e19958316 (view SPL)Fluphenazine Hydrochloride Tablets, USPprescriptionHuman PrescriptionRemedyrepack Inc.2013-09-262521250694
750c7e742-1165-4c45-bbf6-172cf70a387a (view SPL)Fluphenazine Hydrochloride Tablets, USPprescriptionHuman PrescriptionTya PharmaceuticalsRELABEL, REPACK2013-10-142647251438
8653b9cc3-dd87-427e-80f5-1c73bc764393 (view SPL)Fluphenazine Hydrochloride Tablets, USPprescriptionHuman PrescriptionAmerican Health PackagingREPACK2015-09-113680840846, 680840950
969b5a8a7-03b1-41ad-b1ed-f922e3ab4bdd (view SPL)FLUPHENAZINE HYDROCHLORIDE TABLETS, USP1 mg, 2.5 mg, 5 mg and 10 mgprescriptionHuman PrescriptionState Of Florida Doh Central Pharmacyrepack2010-04-132538080247, 538080600
106cd6ba35-3481-48c1-87db-dc74ce9d7d75 (view SPL)Fluphenazine Hydrochloride Tablets, USPprescriptionHuman PrescriptionLannett Company, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2011-11-187005271788, 005271789, 005271790, 005271791
11a61e5bf9-b545-43e9-9f20-cdcb31abda91 (view SPL)prescriptionHuman PrescriptionMylan Institutional Inc.2013-02-013510790485, 510790486, 510790487, 510790488
12b20e1d8a-1040-48ad-b0d5-adf1fa18e6e9 (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2011-08-0215493490005
13bd9c7abe-ad50-4409-b841-e60b1ee5e915 (view SPL)Fluphenazine Hydrochloride Tablets, USPprescriptionHuman PrescriptionClinical Solutions WholesaleRELABEL, REPACK2014-07-011581181436, 581181437, 581181438, 581181439
14c11bd5c4-0c84-4ce8-ab91-a4fb2d1bf203 (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2011-10-251493490598
15e235e2ea-9d09-426f-8849-468302aee1ae (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2011-07-111493490369
16e2cfc2bf-8916-4e34-9a25-79efd74d00d1 (view SPL)Fluphenazine Hydrochloride Tablets, USPprescriptionHuman PrescriptionSandoz Inc2013-10-1414007811436, 007811437, 007811438, 007811439

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