Quinidine Extended Release Oral Tablet

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Mutual Pharmaceutical Company, Inc. (2015-02-13)
Oldest Current Product
1987-02-10
License(s)
ANDA
RxNORM
EXTENDED RELEASE ORAL TABLET\QUINIDINE
FDAOB
ORAL\TABLET, EXTENDED RELEASE\QUINIDINE GLUCONATE
SPL Active
ORAL\TABLET, EXTENDED RELEASE\QUINIDINE GLUCONATE
SPL Moiety
ORAL\TABLET, EXTENDED RELEASE\QUINIDINE

product(s) by strength(s)

quinidine gluconate 324 mg extended release oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1534890141ANDAMutual Pharmaceutical Company, Inc.1987-02-10QUINIDINE GLUCONATEORALTABLET, EXTENDED RELEASEANDA0893385023f053-fcc4-4c2c-aa59-9ec198ad185e
2547380901ANDARichmond Pharmaceuticals1987-02-10QUINIDINE GLUCONATEORALTABLET, EXTENDED RELEASEANDA0893384fb02ad7-6e93-4aff-9aca-5162559b99a5

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1681512701ANDACarilion Materials Management1987-02-10QUINIDINE GLUCONATEORALTABLET, EXTENDED RELEASE534890141ANDA0893383af30c3b-944e-4293-baa5-38965b1d1137

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA087448QUINATIMETrueWATSON LABORATORIES INCANDA087448_001
2ANDA087785QUINIDINE GLUCONATETrueWATSON LABORATORIES INC1983-01-24ANDA087785_001
3ANDA087810QUINIDINE GLUCONATETrueWATSON LABORATORIES INC1982-09-29ANDA087810_001
4ANDA088081QUINALANTrueLANNETT CO INC1986-02-10ANDA088081_001
5ANDA088431QUINIDINE GLUCONATETrueCYCLE PHARMACEUTICALS LTD1984-01-06ANDA088431_001
6ANDA088582QUINIDINE GLUCONATETrueASCOT HOSP PHARMACEUTICALS INC DIV TRAVENOL LABORATORIES INC1985-06-17ANDA088582_001
7ANDA089164QUINIDINE GLUCONATETrueSUPERPHARM CORP1985-11-21ANDA089164_001
8ANDA089338QUINIDINE GLUCONATEMUTUAL PHARMACEUTICAL CO INC1987-02-11ANDA089338_001
9ANDA089476QUINIDINE GLUCONATETrueHALSEY DRUG CO INC1987-04-10ANDA089476_001
10ANDA089894QUINIDINE GLUCONATETrueSANDOZ INC1988-12-15ANDA089894_001
11NDA016647QUINAGLUTETrueBAYER HEALTHCARE PHARMACEUTICALS INCNDA016647_001
12NDA017917DURAQUINTrueWARNER CHILCOTT DIV WARNER LAMBERT CONDA017917_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA087448_001discontinuedQUINIDINE GLUCONATE (324MG)ORALTABLET, EXTENDED RELEASEFalseQUINATIME
2ANDA087785_001discontinuedQUINIDINE GLUCONATE (324MG)ORALTABLET, EXTENDED RELEASEFalse1983-01-24QUINIDINE GLUCONATE
3ANDA087810_001discontinuedQUINIDINE GLUCONATE (324MG)ORALTABLET, EXTENDED RELEASEFalse1982-09-29QUINIDINE GLUCONATE
4ANDA088081_001discontinuedQUINIDINE GLUCONATE (324MG)ORALTABLET, EXTENDED RELEASEFalse1986-02-10QUINALAN
5ANDA088431_001discontinuedQUINIDINE GLUCONATE (324MG)ORALTABLET, EXTENDED RELEASEFalse1984-01-06QUINIDINE GLUCONATE
6ANDA088582_001discontinuedQUINIDINE GLUCONATE (324MG)ORALTABLET, EXTENDED RELEASEFalse1985-06-17QUINIDINE GLUCONATE
7ANDA089164_001discontinuedQUINIDINE GLUCONATE (324MG)ORALTABLET, EXTENDED RELEASEFalse1985-11-21QUINIDINE GLUCONATE
8ANDA089338_001RXQUINIDINE GLUCONATE (324MG)ORALTABLET, EXTENDED RELEASETrueBX1987-02-11QUINIDINE GLUCONATE
9ANDA089476_001discontinuedQUINIDINE GLUCONATE (324MG)ORALTABLET, EXTENDED RELEASEFalse1987-04-10QUINIDINE GLUCONATE
10ANDA089894_001discontinuedQUINIDINE GLUCONATE (324MG)ORALTABLET, EXTENDED RELEASEFalse1988-12-15QUINIDINE GLUCONATE
11NDA016647_001discontinuedQUINIDINE GLUCONATE (324MG)ORALTABLET, EXTENDED RELEASEFalseQUINAGLUTE
12NDA017917_001discontinuedQUINIDINE GLUCONATE (330MG)ORALTABLET, EXTENDED RELEASEFalseDURAQUIN

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
13af30c3b-944e-4293-baa5-38965b1d1137 (view SPL)QUINIDINE GLUCONATE EXTENDED-RELEASE TABLETS USPprescriptionHuman PrescriptionCarilion Materials ManagementREPACK2009-09-302681512701
24fb02ad7-6e93-4aff-9aca-5162559b99a5 (view SPL)QUINIDINE GLUCONATE EXTENDED-RELEASE TABLETS USPprescriptionHuman PrescriptionRichmond Pharmaceuticals2012-01-122547380901
35023f053-fcc4-4c2c-aa59-9ec198ad185e (view SPL)QUINIDINE GLUCONATEEXTENDED-RELEASE TABLETS USPprescriptionHuman PrescriptionMutual Pharmaceutical Company, Inc.2015-02-133534890141

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