Orphenadrine Oral Tablet

Category(s)
prescription
SPL Type(s)
Human Prescription
Oldest Current Product
2000-02-15
License(s)
ANDA
RxNORM
ORAL TABLET\ORPHENADRINE
FDAOB
ORAL\TABLET, EXTENDED RELEASE\ORPHENADRINE CITRATE
SPL Active
ORAL\TABLET\ORPHENADRINE CITRATE
SPL Moiety
ORAL\TABLET\ORPHENADRINE

product(s) by strength(s)

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1681511463ANDACarilion Materials Management2000-02-15ORPHENADRINE CITRATEORALTABLET001850022ANDA0403279c986cc2-3b57-43c4-b6c8-55ea6383ec9d
2687889306ANDAPreferred Pharmaceuticals, Inc.2000-02-15ORPHENADRINE CITRATEORALTABLET001850022ANDA04032776c0186e-3bad-4378-9f2f-f444d85281bf

application(s)

#idtitledeprecatedapplicantapprovedapproved drugin other drug docs
1ANDA040249ORPHENADRINE CITRATETEDOR PHARMA INC1999-01-29ANDA040249_001Orphenadrine Extended Release Oral Tablet
2ANDA040284ORPHENADRINE CITRATEGAVIS PHARMACEUTICALS LLC1998-06-19ANDA040284_001Orphenadrine Extended Release Oral Tablet
3ANDA040327ORPHENADRINE CITRATESANDOZ INC2000-02-15ANDA040327_001Orphenadrine Extended Release Oral Tablet
4ANDA040368ORPHENADRINE CITRATEIMPAX PHARMACEUTICALS2000-06-23ANDA040368_001Orphenadrine Extended Release Oral Tablet
5ANDA084303ORPHENADRINE CITRATETrueWATSON LABORATORIES INCANDA084303_001Orphenadrine Extended Release Oral Tablet
6ANDA085046ORPHENADRINE CITRATETrueSANDOZ INCANDA085046_001Orphenadrine Extended Release Oral Tablet
7ANDA088067ORPHENADRINE CITRATETrueASCOT HOSP PHARMACEUTICALS INC DIV TRAVENOL LABORATORIES INC1983-04-06ANDA088067_001Orphenadrine Extended Release Oral Tablet
8ANDA091158ORPHENADRINE CITRATEINVAGEN PHARMACEUTICALS INC2012-07-27ANDA091158_001Orphenadrine Extended Release Oral Tablet
9NDA012157NORFLEXTrueMEDICIS PHARMACEUTICAL CORPNDA012157_001Orphenadrine Extended Release Oral Tablet

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA040249_001RXORPHENADRINE CITRATE (100MG)ORALTABLET, EXTENDED RELEASEFalseAB1999-01-29ORPHENADRINE CITRATE
2ANDA040284_001RXORPHENADRINE CITRATE (100MG)ORALTABLET, EXTENDED RELEASEFalseAB1998-06-19ORPHENADRINE CITRATE
3ANDA040327_001RXORPHENADRINE CITRATE (100MG)ORALTABLET, EXTENDED RELEASETrueAB2000-02-15ORPHENADRINE CITRATE
4ANDA040368_001RXORPHENADRINE CITRATE (100MG)ORALTABLET, EXTENDED RELEASEFalseAB2000-06-23ORPHENADRINE CITRATE
5ANDA084303_001discontinuedORPHENADRINE CITRATE (100MG)ORALTABLET, EXTENDED RELEASEFalseORPHENADRINE CITRATE
6ANDA085046_001discontinuedORPHENADRINE CITRATE (100MG)ORALTABLET, EXTENDED RELEASEFalseORPHENADRINE CITRATE
7ANDA088067_001discontinuedORPHENADRINE CITRATE (100MG)ORALTABLET, EXTENDED RELEASEFalse1983-04-06ORPHENADRINE CITRATE
8ANDA091158_001RXORPHENADRINE CITRATE (100MG)ORALTABLET, EXTENDED RELEASEFalseAB2012-07-27ORPHENADRINE CITRATE
9NDA012157_001discontinuedORPHENADRINE CITRATE (100MG)ORALTABLET, EXTENDED RELEASEFalseNORFLEX

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
176c0186e-3bad-4378-9f2f-f444d85281bf (view SPL)Orphenadrine Citrate Extended-Release TabletsprescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.REPACK2015-04-151687889306
29c986cc2-3b57-43c4-b6c8-55ea6383ec9d (view SPL)Orphenadrine Citrate Extended-Release TabletsprescriptionHuman PrescriptionCarilion Materials ManagementREPACK2011-12-202681511463

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