oxybutynin Oral Tablet

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Qualitest Pharmaceuticals (2015-08-24)
Oldest Current Product
1990-09-30
License(s)
ANDA
RxNORM
ORAL TABLET\OXYBUTYNIN
FDAOB
ORAL\TABLET\OXYBUTYNIN CHLORIDE
SPL Active
ORAL\TABLET\OXYBUTYNIN CHLORIDE
SPL Moiety
ORAL\TABLET\OXYBUTYNIN

product(s) by strength(s)

oxybutynin chloride 5 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1006034975ANDAQualitest Pharmaceuticals1997-10-31OXYBUTYNIN CHLORIDEORALTABLETANDA075079fd72314e-773a-4e9d-8aa7-ec51592e4c90
2008320038ANDAUpsher-Smith Laboratories, Inc.2011-11-07OXYBUTYNIN CHLORIDEORALTABLETANDA0746253ee6835a-7a7d-49a9-8460-2f1dd270ead3
3009042821ANDAMajor2004-02-03OXYBUTYNIN CHLORIDEORALTABLETANDA071655b037d82b-a8f0-498d-b096-3ae6507205ed
4501110456ANDAPliva Inc.1990-09-30OXYBUTYNIN CHLORIDEORALTABLETANDA071655cb7aba8d-6913-4f57-8eb4-c6d6ff0b2a29

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1006153512ANDANcs Healthcare Of Ky, Inc Dba Vangard Labs2012-10-30OXYBUTYNIN CHLORIDEORALTABLET006034975ANDA0750792bdf2a79-d631-47de-a282-2744ab6caf44
2105440559ANDABlenheim Pharmacal, Inc.2013-11-13OXYBUTYNIN CHLORIDEORALTABLET501110456ANDA0716550fed0008-6569-3728-e054-00144ff88e88
3216950406ANDARebel Distributors Corp1997-10-31OXYBUTYNIN CHLORIDEORALTABLET006034975ANDA0750799211307b-a1cc-412f-9de2-323d42dfac21
4242360551ANDARemedyrepack Inc.2013-04-05OXYBUTYNIN CHLORIDEORALTABLET501110456ANDA0716559c57f71b-1607-4a4a-92f8-d160e585b520
5332610342ANDAAidarex Pharmaceuticals Llc1997-10-31OXYBUTYNIN CHLORIDEORALTABLET006034975ANDA075079d9e99b34-00c8-4532-9e9b-ea16d91c0168
6353560958ANDALake Erie Medical Dba Quality Care Products Llc1990-09-30OXYBUTYNIN CHLORIDEORALTABLET501110456ANDA071655bdd7aafa-480e-44eb-ad81-257cd0c8bd09
7430630145ANDAPd-Rx Pharmaceuticals, Inc.1997-10-31OXYBUTYNIN CHLORIDEORALTABLET006034975ANDA0750799e22e910-f2f3-4dbb-91c3-09483361fa47
8433530367ANDAAphena Pharma Solutions - Tennessee, Llc1997-10-31OXYBUTYNIN CHLORIDEORALTABLET006034975ANDA075079fad7574c-07fc-4311-90ea-5ccc7244e782
9493490545ANDARemedyrepack Inc.2011-09-29OXYBUTYNIN CHLORIDEORALTABLET501110456ANDA071655b15f1a2c-dcae-4c3e-923f-ec81078ba3c4
10504364777ANDAUnit Dose Services1990-09-30OXYBUTYNIN CHLORIDEORALTABLET501110456ANDA071655ae579cb4-3a03-4138-b277-a87fe5150762
11521250611ANDARemedyrepack Inc.2013-05-29, 2013-07-31, 2015-05-21OXYBUTYNIN CHLORIDEORALTABLET008320038ANDA074625731a85e3-3e20-480e-974e-33beb991b24c, aaf0ef8c-fcae-415a-b15a-d505d1c38e4d, aceb2637-8986-4d4b-a97f-a201287aade1, d4bb11b1-c905-448f-a0e9-1e9c8938b448
12538080618ANDAState Of Florida Doh Central Pharmacy2009-07-01OXYBUTYNIN CHLORIDEORALTABLET006034975ANDA0750795fcc6e9f-d5f0-4521-b6f3-315146b65f82
13538080747ANDAState Of Florida Doh Central Pharmacy2009-07-01OXYBUTYNIN CHLORIDEORALTABLET501110456ANDA071655d2aa1b90-bea7-4a93-b2e7-22710548ff55
14538080873ANDAState Of Florida Doh Central Pharmacy2013-01-01OXYBUTYNIN CHLORIDEORALTABLET008320038ANDA074625841eea91-2112-4940-868d-25ef085e8c76
15545691990ANDAA-S Medication Solutions Llc1997-10-31OXYBUTYNIN CHLORIDEORALTABLET006034975ANDA075079d01d72a8-29c6-42dd-ac19-1d77e5963c77
16548682157ANDAPhysicians Total Care, Inc.2006-12-11OXYBUTYNIN CHLORIDEORALTABLET501110456ANDA07165519fba9db-69ff-4136-ad6b-04a33b6b6789
17551540657ANDACardinal Health2004-02-03OXYBUTYNIN CHLORIDEORALTABLET009042821ANDA0716553a0edd83-7936-4a35-afee-ac92445d4d57
18551540828ANDACardinal Health1997-10-31OXYBUTYNIN CHLORIDEORALTABLET006034975ANDA07507912c48560-20f6-4f2a-a4f3-d2b92acdaee1
19551545537ANDACardinal Health2011-05-20OXYBUTYNIN CHLORIDEORALTABLET510790628ANDA0746252325ddde-9a20-40c6-9a3d-5ac6dc6de91d
20551545628ANDACardinal Health2011-11-07OXYBUTYNIN CHLORIDEORALTABLET008320038ANDA074625254605fb-232a-4e08-a1f8-96bb6d06afee
21551546647ANDACardinal Health2010-01-13OXYBUTYNIN CHLORIDEORALTABLET680840400ANDA075079f3afe813-0d7f-4f78-8795-342be513cc65
22551547225ANDACardinal Health1997-10-31OXYBUTYNIN CHLORIDEORALTABLET006034975ANDA0750794a4dc781-9955-45b8-82a3-75034dd39ccc
23607600980ANDASt Marys Medical Park Pharmacy2013-05-16OXYBUTYNIN CHLORIDEORALTABLET501110456ANDA071655e71d50ad-81eb-4748-a227-62e5a5fd9f17
24636291354ANDABryant Ranch Prepack1997-10-31OXYBUTYNIN CHLORIDEORALTABLET006034975ANDA07507998526d8f-9f39-d138-1cf9-fa5335bf2ba5
25680840400ANDAAmerican Health Packaging2010-01-13OXYBUTYNIN CHLORIDEORALTABLET006034975ANDA075079b332845c-5c31-44d7-a5c0-020c0688b42b
26762370216ANDAMckesson Contract Packaging2011-12-23OXYBUTYNIN CHLORIDEORALTABLET006034975ANDA0750790c019ff6-ce85-4711-a9d1-39804ebfae56

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA070746OXYBUTYNIN CHLORIDETrueUSL PHARMA INC1988-03-10ANDA070746_001
2ANDA071655OXYBUTYNIN CHLORIDETEVA PHARMACEUTICALS USA INC1988-11-14ANDA071655_001
3ANDA072296OXYBUTYNIN CHLORIDETrueQUANTUM PHARMICS LTD1988-12-08ANDA072296_001
4ANDA072485OXYBUTYNIN CHLORIDETrueWATSON LABORATORIES INC1989-04-19ANDA072485_001
5ANDA074625OXYBUTYNIN CHLORIDEUSL PHARMA INC1996-07-31ANDA074625_001
6ANDA075079OXYBUTYNIN CHLORIDEVINTAGE PHARMACEUTICALS INC1997-10-31ANDA075079_001
7NDA017577DITROPANTrueJANSSEN PHARMACEUTICALS INCNDA017577_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA070746_001discontinuedOXYBUTYNIN CHLORIDE (5MG)ORALTABLETFalse1988-03-10OXYBUTYNIN CHLORIDE
2ANDA071655_001RXOXYBUTYNIN CHLORIDE (5MG)ORALTABLETFalseAB1988-11-14OXYBUTYNIN CHLORIDE
3ANDA072296_001discontinuedOXYBUTYNIN CHLORIDE (5MG)ORALTABLETFalse1988-12-08OXYBUTYNIN CHLORIDE
4ANDA072485_001discontinuedOXYBUTYNIN CHLORIDE (5MG)ORALTABLETFalse1989-04-19OXYBUTYNIN CHLORIDE
5ANDA074625_001RXOXYBUTYNIN CHLORIDE (5MG)ORALTABLETFalseAB1996-07-31OXYBUTYNIN CHLORIDE
6ANDA075079_001RXOXYBUTYNIN CHLORIDE (5MG)ORALTABLETTrueAB1997-10-31OXYBUTYNIN CHLORIDE
7NDA017577_001discontinuedOXYBUTYNIN CHLORIDE (5MG)ORALTABLETFalseDITROPAN

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
10c019ff6-ce85-4711-a9d1-39804ebfae56 (view SPL)OXYBUTYNIN CHLORIDE TABLETS, USPprescriptionHuman PrescriptionMckesson Contract PackagingREPACK2012-03-191762370216
20fed0008-6569-3728-e054-00144ff88e88 (view SPL)OXYBUTYNIN CHLORIDE Tablets USPprescriptionHuman PrescriptionBlenheim Pharmacal, Inc.repack2015-02-251105440559
312c48560-20f6-4f2a-a4f3-d2b92acdaee1 (view SPL)OXYBUTYNIN CHLORIDE TABLETS, USPprescriptionHuman PrescriptionCardinal HealthREPACK2011-05-181551540828
419fba9db-69ff-4136-ad6b-04a33b6b6789 (view SPL)OXYBUTYNIN CHLORIDE Tablets USPprescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2013-03-184548682157
52325ddde-9a20-40c6-9a3d-5ac6dc6de91d (view SPL)OXYBUTYNIN CHLORIDE TABLETS, USPprescriptionHuman PrescriptionCardinal HealthREPACK2012-05-082551545537
6254605fb-232a-4e08-a1f8-96bb6d06afee (view SPL)OXYBUTYNIN CHLORIDE TABLETS, USPprescriptionHuman PrescriptionCardinal HealthREPACK2015-01-062551545628
72bdf2a79-d631-47de-a282-2744ab6caf44 (view SPL)Oxybutynin Chloride TabletsprescriptionHuman PrescriptionNcs Healthcare Of Ky, Inc Dba Vangard LabsRELABEL, REPACK2012-11-082006153512
83a0edd83-7936-4a35-afee-ac92445d4d57 (view SPL)OXYBUTYNIN CHLORIDE Tablets USPprescriptionHuman PrescriptionCardinal HealthREPACK2014-04-093551540657
93ee6835a-7a7d-49a9-8460-2f1dd270ead3 (view SPL)OXYBUTYNIN CHLORIDE TABLETS, USPprescriptionHuman PrescriptionUpsher-Smith Laboratories, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2015-08-178008320038
104a4dc781-9955-45b8-82a3-75034dd39ccc (view SPL)OXYBUTYNIN CHLORIDE TABLETS, USPprescriptionHuman PrescriptionCardinal HealthREPACK2015-07-211551547225
115fcc6e9f-d5f0-4521-b6f3-315146b65f82 (view SPL)OXYBUTYNIN CHLORIDE TABLETS, USPprescriptionHuman PrescriptionState Of Florida Doh Central Pharmacyrepack2010-06-071538080618
12731a85e3-3e20-480e-974e-33beb991b24c (view SPL)OXYBUTYNIN CHLORIDE TABLETS, USPprescriptionHuman PrescriptionRemedyrepack Inc.2013-07-311521250611
13841eea91-2112-4940-868d-25ef085e8c76 (view SPL)OXYBUTYNIN CHLORIDE TABLETS, USPprescriptionHuman PrescriptionState Of Florida Doh Central Pharmacyrepack2013-09-261538080873
149211307b-a1cc-412f-9de2-323d42dfac21 (view SPL)OXYBUTYNIN CHLORIDE TABLETS, USPprescriptionHuman PrescriptionRebel Distributors Corprelabel, repack2009-09-041216950406
1598526d8f-9f39-d138-1cf9-fa5335bf2ba5 (view SPL)OXYBUTYNIN CHLORIDEprescriptionHuman PrescriptionBryant Ranch PrepackMANUFACTURE, RELABEL, REPACK1997-10-312636291354
169c57f71b-1607-4a4a-92f8-d160e585b520 (view SPL)OXYBUTYNIN CHLORIDE Tablets USPprescriptionHuman PrescriptionRemedyrepack Inc.2013-04-051242360551
179e22e910-f2f3-4dbb-91c3-09483361fa47 (view SPL)OXYBUTYNIN CHLORIDE TABLETS, USPprescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2011-08-298430630145
18aaf0ef8c-fcae-415a-b15a-d505d1c38e4d (view SPL)OXYBUTYNIN CHLORIDE TABLETS, USPprescriptionHuman PrescriptionRemedyrepack Inc.2015-05-211521250611
19aceb2637-8986-4d4b-a97f-a201287aade1 (view SPL)OXYBUTYNIN CHLORIDE TABLETS, USPprescriptionHuman PrescriptionRemedyrepack Inc.2013-05-291521250611
20ae579cb4-3a03-4138-b277-a87fe5150762 (view SPL)OXYBUTYNIN CHLORIDE Tablets USPprescriptionHuman PrescriptionUnit Dose ServicesREPACK2012-09-283504364777
21b037d82b-a8f0-498d-b096-3ae6507205ed (view SPL)OXYBUTYNIN CHLORIDE Tablets USPprescriptionHuman PrescriptionMajor2012-07-111009042821
22b15f1a2c-dcae-4c3e-923f-ec81078ba3c4 (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2011-09-291493490545
23b332845c-5c31-44d7-a5c0-020c0688b42b (view SPL)OXYBUTYNIN CHLORIDE TABLETS, USPprescriptionHuman PrescriptionAmerican Health PackagingREPACK2014-01-284680840400
24bdd7aafa-480e-44eb-ad81-257cd0c8bd09 (view SPL)OXYBUTYNIN CHLORIDE Tablets USPprescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcrepack2013-07-301353560958
25cb7aba8d-6913-4f57-8eb4-c6d6ff0b2a29 (view SPL)OXYBUTYNIN CHLORIDE Tablets USPprescriptionHuman PrescriptionPliva Inc.2012-09-287501110456
26d01d72a8-29c6-42dd-ac19-1d77e5963c77 (view SPL)OXYBUTYNIN CHLORIDE TABLETS, USPprescriptionHuman PrescriptionA-S Medication Solutions Llcrepack2013-10-061545691990
27d2aa1b90-bea7-4a93-b2e7-22710548ff55 (view SPL)Oxybutynin Chloride Tablets, USPprescriptionHuman PrescriptionState Of Florida Doh Central Pharmacyrepack2010-06-071538080747
28d4bb11b1-c905-448f-a0e9-1e9c8938b448 (view SPL)OXYBUTYNIN CHLORIDE TABLETS, USPprescriptionHuman PrescriptionRemedyrepack Inc.2015-05-211521250611
29d9e99b34-00c8-4532-9e9b-ea16d91c0168 (view SPL)OXYBUTYNIN CHLORIDE TABLETS, USPprescriptionHuman PrescriptionAidarex Pharmaceuticals Llc2014-01-211332610342
30e71d50ad-81eb-4748-a227-62e5a5fd9f17 (view SPL)OXYBUTYNIN CHLORIDE Tablets USPprescriptionHuman PrescriptionSt Marys Medical Park Pharmacymanufacture, relabel, repack2014-10-302607600980
31f3afe813-0d7f-4f78-8795-342be513cc65 (view SPL)OXYBUTYNIN CHLORIDE TABLETS, USPprescriptionHuman PrescriptionCardinal HealthREPACK2014-12-083551546647
32fad7574c-07fc-4311-90ea-5ccc7244e782 (view SPL)OXYBUTYNIN CHLORIDE TABLETS, USPprescriptionHuman PrescriptionAphena Pharma Solutions - Tennessee, LlcRepack2014-05-121433530367
33fd72314e-773a-4e9d-8aa7-ec51592e4c90 (view SPL)OXYBUTYNIN CHLORIDE TABLETS, USPprescriptionHuman PrescriptionQualitest PharmaceuticalsANALYSIS, LABEL, MANUFACTURE, PACK2015-08-2412006034975

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