Orphenadrine Extended Release Oral Tablet

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Eon Labs, Inc. (2011-12-20)
Oldest Current Product
1998-06-19
License(s)
ANDA
RxNORM
EXTENDED RELEASE ORAL TABLET\ORPHENADRINE
FDAOB
ORAL\TABLET, EXTENDED RELEASE\ORPHENADRINE CITRATE
SPL Active
ORAL\TABLET, EXTENDED RELEASE\ORPHENADRINE CITRATE
ORAL\TABLET\ORPHENADRINE CITRATE
SPL Moiety
ORAL\TABLET, EXTENDED RELEASE\ORPHENADRINE
ORAL\TABLET\ORPHENADRINE

product(s) by strength(s)

12 hr orphenadrine citrate 100 mg extended release oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001152011ANDAGlobal Pharmaceuticals2000-06-23ORPHENADRINE CITRATEORALTABLET, EXTENDED RELEASEANDA0403686e89e43d-a3fc-481e-8aed-d6955fa2a14b
2001850022ANDAEon Labs, Inc.2000-02-15ORPHENADRINE CITRATEORALTABLETANDA040327239018ff-cec6-46de-ae9d-26c9ec034a32
3433860480ANDAGavis Pharmaceuticals, Llc1998-06-19ORPHENADRINE CITRATEORALTABLET, EXTENDED RELEASEANDA0402847b76c8a7-dd0c-481c-8299-26dfd38ce066

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1105440283ANDABlenheim Pharmacal, Inc.2011-08-10ORPHENADRINE CITRATEORALTABLET, EXTENDED RELEASE433860480ANDA04028411a33d71-ca38-2da0-e054-00144ff8d46c
2165900177ANDAStat Rx Usa Llc2000-06-23ORPHENADRINE CITRATEORALTABLET, EXTENDED RELEASE001152011ANDA040368e506b8dc-36b3-44f2-9fd6-316233efeb8b
3216950099ANDARebel Distributors Corp1998-06-19ORPHENADRINE CITRATEORALTABLET, EXTENDED RELEASE433860480ANDA04028434769dda-f555-460e-9064-98ab205393c5
4332610088ANDAAidarex Pharmaceuticals Llc1998-06-19ORPHENADRINE CITRATEORALTABLET, EXTENDED RELEASE433860480ANDA04028419b31a8f-d07e-43df-a0f0-a9b34406c904
5333580274ANDARxchange Co.2014-11-15ORPHENADRINE CITRATEORALTABLET, EXTENDED RELEASE433860480ANDA040284b32eb120-fbc3-4ef0-b418-3d1739130475
6353560987ANDALake Erie Medical Dba Quality Care Products Llc2000-02-15ORPHENADRINE CITRATEORALTABLET001850022ANDA0403272fecb370-2763-4e88-b0fa-c0a7ed2ce488
7422910647ANDAAvkare, Inc.2015-11-02ORPHENADRINE CITRATEORALTABLET, EXTENDED RELEASE433860480ANDA040284451093f9-45d6-2025-f79c-c86e65d3d3c3
8425490559ANDAStat Rx Usa Llc2000-06-23ORPHENADRINE CITRATEORALTABLET, EXTENDED RELEASE001152011ANDA040368942ef941-eb4e-4b27-8c79-b2d9ec129641
9430630407ANDAPd-Rx Pharmaceuticals, Inc.1998-06-19ORPHENADRINE CITRATEORALTABLET, EXTENDED RELEASE433860480ANDA04028487d78229-f022-4b42-a03c-4e6a985c714f
10458650363ANDAMedsource Pharmaceuticals2000-02-15ORPHENADRINE CITRATEORALTABLET001850022ANDA0403271d38a57b-946f-0776-e054-00144ff8d46c
11499990046ANDALake Erie Medical Dba Quality Care Products Llc2011-02-07ORPHENADRINE CITRATEORALTABLET, EXTENDED RELEASE433860480ANDA040284233915f1-7d58-4b4c-a2bb-e73179d61d07
12504367601ANDAUnit Dose Services1998-06-19ORPHENADRINE CITRATEORALTABLET, EXTENDED RELEASE433860480ANDA0402842753a96d-406b-47d1-b0a5-3f9e0cebd789
13529590527ANDAH.J. Harkins Company, Inc.2000-06-23ORPHENADRINE CITRATEORALTABLET, EXTENDED RELEASE001152011ANDA040368b0a4eb39-ec35-4e60-99c2-422ef5287585
14545690838ANDAA-S Medication Solutions Llc1998-06-19ORPHENADRINE CITRATEORALTABLET, EXTENDED RELEASE433860480ANDA040284ceb53c19-9ea0-4ddf-8b6d-2c30ddaa8705
15548684102ANDAPhysicians Total Care, Inc.2000-04-17ORPHENADRINE CITRATEORALTABLET, EXTENDED RELEASE433860480ANDA04028428d5753e-862a-4811-8b9f-6707361f8475
16552890877ANDAPd-Rx Pharmaceuticals, Inc.1998-06-19ORPHENADRINE CITRATEORALTABLET, EXTENDED RELEASE433860480ANDA040284d0ea1b70-97a9-4593-905e-93c53ead73a7
17581180480ANDAClinical Solutions Wholesale1998-06-19ORPHENADRINE CITRATEORALTABLET, EXTENDED RELEASE433860480ANDA0402846cc36873-1f83-4233-aa12-d6c4fb4f9733
18619190177ANDADirect Rx2014-01-01ORPHENADRINE CITRATEORALTABLET, EXTENDED RELEASE433860480ANDA0402848a258480-2f47-4b62-850c-1beed383ba29
19631870122ANDAProficient Rx Lp1998-06-19ORPHENADRINE CITRATEORALTABLET, EXTENDED RELEASE433860480ANDA040284cf620257-7497-44c1-9853-87f96d262fbd
20636291564ANDABryant Ranch Prepack1998-06-19ORPHENADRINE CITRATEORALTABLET, EXTENDED RELEASE433860480ANDA0402848408d24e-3948-548d-bb12-b1edf0c05e12
21663360554ANDADispensing Solutions, Inc.1998-06-19ORPHENADRINE CITRATEORALTABLET, EXTENDED RELEASE433860480ANDA040284c8dcda72-efd3-4203-8cc3-f6121cfdd5b0
22680840820ANDAAmerican Health Packaging2014-09-15ORPHENADRINE CITRATEORALTABLET, EXTENDED RELEASE001152011ANDA04036817a5fd73-9342-4ce7-8730-530b07337362
23687889138ANDAPreferred Pharmaceuticals, Inc.1998-06-19ORPHENADRINE CITRATEORALTABLET, EXTENDED RELEASE433860480ANDA0402848ca9438d-320f-4499-aee7-6b8ca7cccc65
24687889150ANDAPreferred Pharmaceuticals, Inc.1998-06-19ORPHENADRINE CITRATEORALTABLET, EXTENDED RELEASE433860480ANDA0402840f50125a-6d89-4b2b-b48b-daac6129182c

application(s)

#idtitledeprecatedapplicantapprovedapproved drugin other drug docs
1ANDA040249ORPHENADRINE CITRATETEDOR PHARMA INC1999-01-29ANDA040249_001Orphenadrine Oral Tablet
2ANDA040284ORPHENADRINE CITRATEGAVIS PHARMACEUTICALS LLC1998-06-19ANDA040284_001Orphenadrine Oral Tablet
3ANDA040327ORPHENADRINE CITRATESANDOZ INC2000-02-15ANDA040327_001Orphenadrine Oral Tablet
4ANDA040368ORPHENADRINE CITRATEIMPAX PHARMACEUTICALS2000-06-23ANDA040368_001Orphenadrine Oral Tablet
5ANDA084303ORPHENADRINE CITRATETrueWATSON LABORATORIES INCANDA084303_001Orphenadrine Oral Tablet
6ANDA085046ORPHENADRINE CITRATETrueSANDOZ INCANDA085046_001Orphenadrine Oral Tablet
7ANDA088067ORPHENADRINE CITRATETrueASCOT HOSP PHARMACEUTICALS INC DIV TRAVENOL LABORATORIES INC1983-04-06ANDA088067_001Orphenadrine Oral Tablet
8ANDA091158ORPHENADRINE CITRATEINVAGEN PHARMACEUTICALS INC2012-07-27ANDA091158_001Orphenadrine Oral Tablet
9NDA012157NORFLEXTrueMEDICIS PHARMACEUTICAL CORPNDA012157_001Orphenadrine 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)
10f50125a-6d89-4b2b-b48b-daac6129182c (view SPL)Orphenadrine Citrate Extended-Release TabletsprescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.repack2010-01-291687889150
211a33d71-ca38-2da0-e054-00144ff8d46c (view SPL)Orphenadrine Citrate Extended-Release Tablets Gavis Pharmaceuticals, LLC.prescriptionHuman PrescriptionBlenheim Pharmacal, Inc.repack2015-03-191105440283
317a5fd73-9342-4ce7-8730-530b07337362 (view SPL)Orphenadrine Citrate Extended-Release TabletsprescriptionHuman PrescriptionAmerican Health PackagingREPACK2014-10-071680840820
419b31a8f-d07e-43df-a0f0-a9b34406c904 (view SPL)Orphenadrine Citrate Extended-Release TabletsprescriptionHuman PrescriptionAidarex Pharmaceuticals Llc2012-10-041332610088
51d38a57b-946f-0776-e054-00144ff8d46c (view SPL)Orphenadrine Citrate Extended-Release TabletsprescriptionHuman PrescriptionMedsource Pharmaceuticalsrepack2015-08-131458650363
6233915f1-7d58-4b4c-a2bb-e73179d61d07 (view SPL)Orphenadrine Citrate Extended-Release TabletsprescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products LlcMANUFACTURE, repack2011-11-183221499990046
7239018ff-cec6-46de-ae9d-26c9ec034a32 (view SPL)Orphenadrine Citrate Extended-Release TabletsprescriptionHuman PrescriptionEon Labs, Inc.2011-12-2014001850022
82753a96d-406b-47d1-b0a5-3f9e0cebd789 (view SPL)Orphenadrine Citrate Extended-Release TabletsprescriptionHuman PrescriptionUnit Dose ServicesREPACK2011-10-212504367601
928d5753e-862a-4811-8b9f-6707361f8475 (view SPL)Orphenadrine Citrate Extended-Release TabletsprescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2010-01-291548684102
102fecb370-2763-4e88-b0fa-c0a7ed2ce488 (view SPL)Orphenadrine Citrate Extended-Release TabletsprescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcrepack2013-05-311353560987
1134769dda-f555-460e-9064-98ab205393c5 (view SPL)Orphenadrine Citrate Extended-Release TabletsprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2010-10-221216950099
12451093f9-45d6-2025-f79c-c86e65d3d3c3 (view SPL)Orphenadrine Citrate Extended-Release TabletsRx OnlyprescriptionHuman PrescriptionAvkare, Inc.2015-11-021422910647
136cc36873-1f83-4233-aa12-d6c4fb4f9733 (view SPL)Orphenadrine Citrate Extended-Release TabletsprescriptionHuman PrescriptionClinical Solutions Wholesalerelabel, repack2013-08-112581180480
146e89e43d-a3fc-481e-8aed-d6955fa2a14b (view SPL)Orphenadrine Citrate Extended-release Tablets, 100 mgprescriptionHuman PrescriptionGlobal PharmaceuticalsMANUFACTURE, REPACK2013-11-142001152011
157b76c8a7-dd0c-481c-8299-26dfd38ce066 (view SPL)Orphenadrine Citrate Extended-Release Tablets Gavis Pharmaceuticals, LLC.prescriptionHuman PrescriptionGavis Pharmaceuticals, LlcANALYSIS, MANUFACTURE2013-06-1812433860480
168408d24e-3948-548d-bb12-b1edf0c05e12 (view SPL)Orphenadrine Citrate Extended-Release TabletsprescriptionHuman PrescriptionBryant Ranch PrepackMANUFACTURE, RELABEL, REPACK2012-10-122636291564
1787d78229-f022-4b42-a03c-4e6a985c714f (view SPL)Orphenadrine Citrate Extended-Release Tablets Gavis Pharmaceuticals, LLC.prescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2013-06-1816430630407
188a258480-2f47-4b62-850c-1beed383ba29 (view SPL)Orphenadrine CitrateprescriptionHuman PrescriptionDirect Rxrelabel, repack2015-11-052619190177
198ca9438d-320f-4499-aee7-6b8ca7cccc65 (view SPL)Orphenadrine Citrate Extended-Release Tablets Gavis Pharmaceuticals, LLC.prescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.REPACK2015-03-033687889138
20942ef941-eb4e-4b27-8c79-b2d9ec129641 (view SPL)Orphenadrine Citrate Extended-release Tablets, 100 mgprescriptionHuman PrescriptionStat Rx Usa Llcrelabel, repack2012-05-011425490559
21b0a4eb39-ec35-4e60-99c2-422ef5287585 (view SPL)Orphenadrine CitrateExtended-release Tablets, 100 mgprescriptionHuman PrescriptionH.J. Harkins Company, Inc.MANUFACTURE, REPACK2011-08-112529590527
22b32eb120-fbc3-4ef0-b418-3d1739130475 (view SPL)Orphenadrine Citrate Extended-Release Tablets Gavis Pharmaceuticals, LLC.prescriptionHuman PrescriptionRxchange Co.manufacture2014-12-012333580274
23c8dcda72-efd3-4203-8cc3-f6121cfdd5b0 (view SPL)Orphenadrine Citrate Extended-Release Tablets Gavis Pharmaceuticals, LLC.prescriptionHuman PrescriptionDispensing Solutions, Inc.relabel, repack2013-07-242663360554
24ceb53c19-9ea0-4ddf-8b6d-2c30ddaa8705 (view SPL)Orphenadrine Citrate Extended-Release TabletsprescriptionHuman PrescriptionA-S Medication Solutions Llcrepack2013-06-171545690838
25cf620257-7497-44c1-9853-87f96d262fbd (view SPL)Orphenadrine Citrate Extended-Release Tablets Gavis Pharmaceuticals, LLC.prescriptionHuman PrescriptionProficient Rx LpRELABEL, REPACK2014-06-062631870122
26d0ea1b70-97a9-4593-905e-93c53ead73a7 (view SPL)Orphenadrine Citrate Extended-Release TabletsprescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2011-10-2111552890877
27e506b8dc-36b3-44f2-9fd6-316233efeb8b (view SPL)prescriptionHuman PrescriptionStat Rx Usa Llcrelabel, repack2011-04-201165900177

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