Flavoxate Oral Tablet

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Paddock Laboratories, Llc (2014-07-24)
Oldest Current Product
2003-08-28
License(s)
ANDA
RxNORM
ORAL TABLET\FLAVOXATE
FDAOB
ORAL\TABLET\FLAVOXATE HYDROCHLORIDE
SPL Active
ORAL\TABLET, FILM COATED\FLAVOXATE HYDROCHLORIDE
ORAL\TABLET\FLAVOXATE HYDROCHLORIDE
SPL Moiety
ORAL\TABLET, FILM COATED\FLAVOXATE
ORAL\TABLET\FLAVOXATE

product(s) by strength(s)

flavoxate hydrochloride 100 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001151811ANDAGlobal Pharmaceuticals2003-08-28FLAVOXATE HYDROCHLORIDEORALTABLET, FILM COATEDANDA0762347a60170f-37d1-429f-9726-b4ae27015ddf
2005740115ANDAPaddock Laboratories, Llc2004-12-22FLAVOXATE HYDROCHLORIDEORALTABLET, FILM COATEDANDA076831a9c44c4b-5b3c-45bf-9bc9-ce858e3d06c5
3428060058ANDAEpic Pharma, Llc2011-02-21FLAVOXATE HYDROCHLORIDEORALTABLETANDA076835b4260d7e-2ab3-49f6-aa57-bae19a23d82a
4512240154ANDATagi Pharma, Inc.2011-03-25FLAVOXATE HYDROCHLORIDEORALTABLET, FILM COATEDANDA0768355cc7ad48-0918-444d-a97e-64c43852f3a6

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1502680324ANDAAvpak2012-11-30FLAVOXATE HYDROCHLORIDEORALTABLET428060058ANDA0768359422e67e-d64c-3ba1-b2b9-ca9d3eeda743
2548686326ANDAPhysicians Total Care, Inc.2012-01-04FLAVOXATE HYDROCHLORIDEORALTABLET, FILM COATED512240154ANDA076835e05f4892-0be8-4178-a274-3289edca0137
3604290290ANDAGolden State Medical Supply, Inc.2011-02-21FLAVOXATE HYDROCHLORIDEORALTABLET428060058ANDA07683522a99f74-2718-48b3-b686-caf102d3071c
4681513826ANDACarilion Materials Management2004-12-22FLAVOXATE HYDROCHLORIDEORALTABLET, FILM COATED005740115ANDA0768314c4470d2-4e62-4cce-af3c-113b6be7d986

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA076234FLAVOXATE HYDROCHLORIDEIMPAX PHARMACEUTICALS2003-08-28ANDA076234_001
2ANDA076831FLAVOXATE HYDROCHLORIDEPADDOCK LABORATORIES LLC2004-12-16ANDA076831_001
3ANDA076835FLAVOXATE HYDROCHLORIDEEPIC PHARMA LLC2005-11-30ANDA076835_001
4NDA016769URISPASTrueORTHO MCNEIL JANSSEN PHARMACEUTICALS INCNDA016769_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA076234_001RXFLAVOXATE HYDROCHLORIDE (100MG)ORALTABLETFalseAB2003-08-28FLAVOXATE HYDROCHLORIDE
2ANDA076831_001RXFLAVOXATE HYDROCHLORIDE (100MG)ORALTABLETTrueAB2004-12-16FLAVOXATE HYDROCHLORIDE
3ANDA076835_001RXFLAVOXATE HYDROCHLORIDE (100MG)ORALTABLETFalseAB2005-11-30FLAVOXATE HYDROCHLORIDE
4NDA016769_001discontinuedFLAVOXATE HYDROCHLORIDE (100MG)ORALTABLETFalseURISPAS

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
122a99f74-2718-48b3-b686-caf102d3071c (view SPL)Flavoxate Hydrochloride Tablets 100 mg, Film-CoatedRx onlyprescriptionHuman PrescriptionGolden State Medical Supply, Inc.RELABEL, REPACK2011-07-011604290290
24c4470d2-4e62-4cce-af3c-113b6be7d986 (view SPL)Flavoxate HCl Tablets 100 mgprescriptionHuman PrescriptionCarilion Materials ManagementREPACK2014-07-242681513826
35cc7ad48-0918-444d-a97e-64c43852f3a6 (view SPL)Flavoxate Hydrochloride Tablets, 100 mg Film-CoatedprescriptionHuman PrescriptionTagi Pharma, Inc.2011-02-171512240154
47a60170f-37d1-429f-9726-b4ae27015ddf (view SPL)FLAVOXATE HYDROCHLORIDE TABLETS, 100 mgprescriptionHuman PrescriptionGlobal PharmaceuticalsMANUFACTURE, REPACK2010-09-171001151811
59422e67e-d64c-3ba1-b2b9-ca9d3eeda743 (view SPL)Flavoxate Hydrochloride Tablets 100 mg, Film-CoatedRx onlyprescriptionHuman PrescriptionAvpak2014-09-243502680324
6a9c44c4b-5b3c-45bf-9bc9-ce858e3d06c5 (view SPL)Flavoxate HCl Tablets 100 mgprescriptionHuman PrescriptionPaddock Laboratories, Llc2014-07-247005740115
7b4260d7e-2ab3-49f6-aa57-bae19a23d82a (view SPL)Flavoxate Hydrochloride Tablets 100 mg, Film-CoatedRx onlyprescriptionHuman PrescriptionEpic Pharma, LlcMANUFACTURE2015-03-164428060058
8e05f4892-0be8-4178-a274-3289edca0137 (view SPL)Flavoxate Hydrochloride Tablets, 100 mg Film-CoatedprescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2012-01-251548686326

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