Pentoxifylline Extended Release Oral Tablet

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Mylan Pharmaceuticals Inc. (2015-09-16)
Oldest Current Product
1997-07-08
License(s)
ANDA
RxNORM
EXTENDED RELEASE ORAL TABLET\PENTOXIFYLLINE
FDAOB
ORAL\TABLET, EXTENDED RELEASE\PENTOXIFYLLINE
SPL Active
ORAL\TABLET, EXTENDED RELEASE\PENTOXIFYLLINE
ORAL\TABLET, FILM COATED, EXTENDED RELEASE\PENTOXIFYLLINE
SPL Moiety
ORAL\TABLET, EXTENDED RELEASE\PENTOXIFYLLINE
ORAL\TABLET, FILM COATED, EXTENDED RELEASE\PENTOXIFYLLINE

product(s) by strength(s)

pentoxifylline 400 mg extended release oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000935116ANDATeva Pharmaceuticals Usa Inc1998-07-31PENTOXIFYLLINEORALTABLET, EXTENDED RELEASEANDA07502874a51821-8d41-47a6-88e9-6ed3c20df7db
2003780357ANDAMylan Pharmaceuticals Inc.1997-07-08PENTOXIFYLLINEORALTABLET, FILM COATED, EXTENDED RELEASEANDA0744250ea37402-987c-4964-a810-e8989e0e5358
3009045448ANDAMajor2004-02-16PENTOXIFYLLINEORALTABLET, EXTENDED RELEASEANDA07519159c9a583-1f93-480f-879c-457a574374da
4605050033ANDAApotex Corp1999-06-10PENTOXIFYLLINEORALTABLET, EXTENDED RELEASEANDA07519140ae2d9a-0d95-640d-0640-f76e7e1a13cb
5686820101ANDAOceanside Pharmaceuticals2014-08-22PENTOXIFYLLINEORALTABLET, EXTENDED RELEASEANDA075028c28cf3c3-8c13-46c6-a051-6de99db19882

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1538080757ANDAState Of Florida Doh Central Pharmacy2009-07-01PENTOXIFYLLINEORALTABLET, EXTENDED RELEASE000935116ANDA07519973f8cef4-39f3-4f71-b3cc-8da07b8fd65f

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1006154523ANDANcs Healthcare Of Ky, Inc Dba Vangard Labs2009-09-21PENTOXIFYLLINEORALTABLET, FILM COATED, EXTENDED RELEASE003780357ANDA0744257096593b-0054-4d51-83df-0208ccdcc147
2165900856ANDAStat Rx Usa Llc1998-07-20PENTOXIFYLLINEORALTABLET, EXTENDED RELEASE000935116ANDA07502824eb2c70-ca20-490c-837c-9de4f5914225
3332610992ANDAAidarex Pharmaceuticals Llc1999-06-10PENTOXIFYLLINEORALTABLET, EXTENDED RELEASE605050033ANDA075191e09702d1-43d4-47ed-9563-5af3cd667727
4422910687ANDAAvkare, Inc.2013-07-31PENTOXIFYLLINEORALTABLET, EXTENDED RELEASE000935116ANDA0750284645a25f-f6d8-02a7-5a36-b2a413ab75e9
5430630188ANDAPd-Rx Pharmaceuticals, Inc.2010-11-15PENTOXIFYLLINEORALTABLET, EXTENDED RELEASE000935116ANDA075028a2363acb-717f-4401-ad5d-ea068e971410
6499990542ANDALake Erie Medical Dba Quality Care Products Llc1998-07-31PENTOXIFYLLINEORALTABLET, EXTENDED RELEASE000935116ANDA0750283c85a22f-4d48-49c7-8f03-51d522aae4f8
7510790889ANDAMylan Institutional Inc.1998-01-15PENTOXIFYLLINEORALTABLET, FILM COATED, EXTENDED RELEASE003780357ANDA07442581a0e173-0dc6-4d46-a699-37d2ac5b4df1
8521250214ANDARemedyrepack Inc.2013-03-29PENTOXIFYLLINEORALTABLET, FILM COATED, EXTENDED RELEASE003780357ANDA0744250bf7f0b1-987d-4e73-9bb3-3a0cc3a79c76
9538080516ANDAState Of Florida Doh Central Pharmacy2009-07-01PENTOXIFYLLINEORALTABLET, FILM COATED, EXTENDED RELEASE605050033ANDA075191a6c39757-4551-4493-b27f-5b311fd1fc77
10538080758ANDAState Of Florida Doh Central Pharmacy2009-07-01PENTOXIFYLLINEORALTABLET, FILM COATED, EXTENDED RELEASE003780357ANDA07442583d5ef4b-8b46-48b6-ae5a-9a0e493350a0
11548684515ANDAPhysicians Total Care, Inc.2003-03-25PENTOXIFYLLINEORALTABLET, EXTENDED RELEASE000935116ANDA075028edd4dbbc-04ed-4741-9cd9-42e9b744f99e
12551540672ANDACardinal Health2004-02-16PENTOXIFYLLINEORALTABLET, EXTENDED RELEASE009045448ANDA07519142bc2552-3c8c-47c9-aa4f-2487096f4a2a
13551545483ANDACardinal Health2010-07-23PENTOXIFYLLINEORALTABLET, FILM COATED, EXTENDED RELEASE510790889ANDA074425af8bf978-45e7-4548-a314-beb205f36749
14551546243ANDACardinal Health2009-09-21PENTOXIFYLLINEORALTABLET, FILM COATED, EXTENDED RELEASE003780357ANDA0744254b6435e3-d102-449f-b21b-ac53130b3c78
15551546662ANDACardinal Health1999-06-10PENTOXIFYLLINEORALTABLET, FILM COATED, EXTENDED RELEASE605050033ANDA0751914963034a-3667-472e-97e9-5e07db32b68f
16604290703ANDAGolden State Medical Supply, Inc.2001-06-18PENTOXIFYLLINEORALTABLET, EXTENDED RELEASE605050033ANDA075191b218b02c-e6a1-410c-95fa-f798260c51ab
17636292910ANDABryant Ranch Prepack1999-06-10PENTOXIFYLLINEORALTABLET, EXTENDED RELEASE605050033ANDA07519184816505-9253-41cf-8894-2b2d0e4aff67
18675440252ANDAAphena Pharma Solutions - Tennessee, Inc.1999-06-10PENTOXIFYLLINEORALTABLET, EXTENDED RELEASE605050033ANDA07519173a76a95-ada5-4707-ab89-fd60e8eda64e
19687889742ANDAPreferred Pharmaceuticals, Inc.2012-09-28PENTOXIFYLLINEORALTABLET, EXTENDED RELEASE605050033ANDA075191ff347283-b9ce-4570-8501-43cab7e2ecc8
20762370225ANDAMckesson Contract Packaging2012-01-30PENTOXIFYLLINEORALTABLET, FILM COATED, EXTENDED RELEASE003780357ANDA0744256b902d5e-1526-4f80-bb31-57c1b4e5a4f5

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA074425PENTOXIFYLLINEMYLAN PHARMACEUTICALS INC1997-07-08ANDA074425_001
2ANDA074874PENTOXIFYLLINEPLIVA INC1999-05-25ANDA074874_001
3ANDA074877PENTOXIFYLLINETrueHERITAGE PHARMACEUTICALS INC1997-07-08ANDA074877_001
4ANDA074878PENTOXIFYLLINETrueACTAVIS ELIZABETH LLC1997-07-09ANDA074878_001
5ANDA074962PENTOXILUPSHER SMITH LABORATORIES INC1999-03-31ANDA074962_001
6ANDA075028PENTOXIFYLLINEVALEANT PHARMACEUTICALS NORTH AMERICA LLC1998-07-20ANDA075028_001
7ANDA075093PENTOXIFYLLINEIMPAX LABORATORIES INC1999-08-10ANDA075093_001
8ANDA075107PENTOXIFYLLINETrueWATSON LABORATORIES INC1998-09-04ANDA075107_001
9ANDA075191PENTOXIFYLLINEAPOTEX INC1999-06-09ANDA075191_001
10ANDA075199PENTOXIFYLLINETrueTEVA PHARMACEUTICALS USA INC1999-09-03ANDA075199_001
11NDA018631TRENTALTrueSANOFI AVENTIS US LLC1984-08-30NDA018631_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA074425_001RXPENTOXIFYLLINE (400MG)ORALTABLET, EXTENDED RELEASEFalseAB1997-07-08PENTOXIFYLLINE
2ANDA074874_001RXPENTOXIFYLLINE (400MG)ORALTABLET, EXTENDED RELEASEFalseAB1999-05-25PENTOXIFYLLINE
3ANDA074877_001discontinuedPENTOXIFYLLINE (400MG)ORALTABLET, EXTENDED RELEASEFalse1997-07-08PENTOXIFYLLINE
4ANDA074878_001discontinuedPENTOXIFYLLINE (400MG)ORALTABLET, EXTENDED RELEASEFalse1997-07-09PENTOXIFYLLINE
5ANDA074962_001RXPENTOXIFYLLINE (400MG)ORALTABLET, EXTENDED RELEASEFalseAB1999-03-31PENTOXIL
6ANDA075028_001RXPENTOXIFYLLINE (400MG)ORALTABLET, EXTENDED RELEASEFalseAB1998-07-20PENTOXIFYLLINE
7ANDA075093_001RXPENTOXIFYLLINE (400MG)ORALTABLET, EXTENDED RELEASEFalseAB1999-08-10PENTOXIFYLLINE
8ANDA075107_001discontinuedPENTOXIFYLLINE (400MG)ORALTABLET, EXTENDED RELEASEFalse1998-09-04PENTOXIFYLLINE
9ANDA075191_001RXPENTOXIFYLLINE (400MG)ORALTABLET, EXTENDED RELEASEFalseAB1999-06-09PENTOXIFYLLINE
10ANDA075199_001discontinuedPENTOXIFYLLINE (400MG)ORALTABLET, EXTENDED RELEASEFalse1999-09-03PENTOXIFYLLINE
11NDA018631_001discontinuedPENTOXIFYLLINE (400MG)ORALTABLET, EXTENDED RELEASEFalse1984-08-30TRENTAL

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
10bf7f0b1-987d-4e73-9bb3-3a0cc3a79c76 (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2013-03-291521250214
20ea37402-987c-4964-a810-e8989e0e5358 (view SPL)prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2015-09-167003780357
324eb2c70-ca20-490c-837c-9de4f5914225 (view SPL)Pentoxifylline Extended-release Tablets, 400 mg.prescriptionHuman PrescriptionStat Rx Usa Llcrelabel, repack2011-04-261165900856
43c85a22f-4d48-49c7-8f03-51d522aae4f8 (view SPL)PENTOXIFYLLINE Extended-Release Tablets, 400 mgprescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcrepack2015-03-241499990542
540ae2d9a-0d95-640d-0640-f76e7e1a13cb (view SPL)PENTOXIFYLLINE EXTENDED-RELEASE TABLETS, USP 400 mg Rx OnlyprescriptionHuman PrescriptionApotex Corp2015-07-025605050033
642bc2552-3c8c-47c9-aa4f-2487096f4a2a (view SPL)PENTOXIFYLLINE EXTENDED-RELEASE TABLETS, USP 400 mgprescriptionHuman PrescriptionCardinal HealthREPACK2013-03-271551540672
74645a25f-f6d8-02a7-5a36-b2a413ab75e9 (view SPL)Pentoxifylline Extended-release Tablets, 400 mg.prescriptionHuman PrescriptionAvkare, Inc.2013-12-053422910687
84963034a-3667-472e-97e9-5e07db32b68f (view SPL)PENTOXIFYLLINE EXTENDED-RELEASE TABLETS, USP 400 mgprescriptionHuman PrescriptionCardinal HealthREPACK2011-06-211551546662
94b6435e3-d102-449f-b21b-ac53130b3c78 (view SPL)prescriptionHuman PrescriptionCardinal HealthREPACK2011-05-181551546243
1059c9a583-1f93-480f-879c-457a574374da (view SPL)PENTOXIFYLLINE EXTENDED-RELEASE TABLETS, USP 400 mgprescriptionHuman PrescriptionMajor2012-07-201009045448
116b902d5e-1526-4f80-bb31-57c1b4e5a4f5 (view SPL)prescriptionHuman PrescriptionMckesson Contract PackagingREPACK2012-02-011762370225
127096593b-0054-4d51-83df-0208ccdcc147 (view SPL)PENTOXIFYLLINE EXTENDED-RELEASE TABLETS, USP 400MG RX onlyprescriptionHuman PrescriptionNcs Healthcare Of Ky, Inc Dba Vangard LabsREPACK2015-08-247006154523
1373a76a95-ada5-4707-ab89-fd60e8eda64e (view SPL)PENTOXIFYLLINE EXTENDED-RELEASE TABLETS, USP 400 mgprescriptionHuman PrescriptionAphena Pharma Solutions - Tennessee, Inc.Repack2014-06-251675440252
1473f8cef4-39f3-4f71-b3cc-8da07b8fd65f (view SPL)Pentoxifylline Extended-release Tablets, 400 mg.prescriptionHuman PrescriptionState Of Florida Doh Central Pharmacyrepack2010-05-311538080757
1574a51821-8d41-47a6-88e9-6ed3c20df7db (view SPL)PENTOXIFYLLINE Extended-Release Tablets, 400 mgprescriptionHuman PrescriptionTeva Pharmaceuticals Usa IncMANUFACTURE2014-07-016000935116
1681a0e173-0dc6-4d46-a699-37d2ac5b4df1 (view SPL)prescriptionHuman PrescriptionMylan Institutional Inc.2013-10-042510790889
1783d5ef4b-8b46-48b6-ae5a-9a0e493350a0 (view SPL)prescriptionHuman PrescriptionState Of Florida Doh Central Pharmacyrepack2010-05-311538080758
1884816505-9253-41cf-8894-2b2d0e4aff67 (view SPL)PENTOXIFYLLINE EXTENDED-RELEASE TABLETS, USP 400 mgprescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2010-05-101000636292910
19a2363acb-717f-4401-ad5d-ea068e971410 (view SPL)Pentoxifylline Extended-release Tablets, 400 mg.prescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2010-11-082430630188
20a6c39757-4551-4493-b27f-5b311fd1fc77 (view SPL)prescriptionHuman PrescriptionState Of Florida Doh Central Pharmacyrepack2010-05-311538080516
21af8bf978-45e7-4548-a314-beb205f36749 (view SPL)prescriptionHuman PrescriptionCardinal HealthREPACK2011-05-251551545483
22b218b02c-e6a1-410c-95fa-f798260c51ab (view SPL)PENTOXIFYLLINE EXTENDED-RELEASE TABLETS, USPprescriptionHuman PrescriptionGolden State Medical Supply, Inc.RELABEL, REPACK2012-01-091604290703
23c28cf3c3-8c13-46c6-a051-6de99db19882 (view SPL)PENTOXIFYLLINE Extended-Release Tablets, 400 mgprescriptionHuman PrescriptionOceanside PharmaceuticalsMANUFACTURE2015-04-082686820101
24e09702d1-43d4-47ed-9563-5af3cd667727 (view SPL)PENTOXIFYLLINE EXTENDED-RELEASE TABLETS, USP 400 mgprescriptionHuman PrescriptionAidarex Pharmaceuticals Llc2014-01-231332610992
25edd4dbbc-04ed-4741-9cd9-42e9b744f99e (view SPL)Pentoxifylline Extended-release Tablets, 400 mg.prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2012-09-142548684515
26ff347283-b9ce-4570-8501-43cab7e2ecc8 (view SPL)PENTOXIFYLLINE EXTENDED-RELEASE TABLETS, USP 400 mgprescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.REPACK2012-09-281687889742

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