Tinidazole Oral Tablet

Brand(s)
Tindamax
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Mission Pharmacal Company (2013-07-26)
Oldest Current Product
2004-05-17
License(s)
NDA, NDA AUTHORIZED GENERIC, ANDA
RxNORM
ORAL TABLET\TINIDAZOLE
FDAOB
ORAL\TABLET\TINIDAZOLE
SPL Active
ORAL\TABLET, FILM COATED\TINIDAZOLE
ORAL\TABLET\TINIDAZOLE
SPL Moiety
ORAL\TABLET, FILM COATED\TINIDAZOLE
ORAL\TABLET\TINIDAZOLE

product(s) by strength(s)

tinidazole 250 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001788250TindamaxNDAMission Pharmacal Company2004-05-17TINIDAZOLEORALTABLET, FILM COATEDNDA021618a0d01539-8413-4703-94cc-d221918630a1

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000540347ANDARoxane Laboratories, Inc2012-04-30TINIDAZOLEORALTABLET, FILM COATEDANDA2011724d5ea1c2-6126-432f-be61-44fb24d67b7e
2165710214ANDAPack Pharmaceuticals Llc2013-10-09TINIDAZOLEORALTABLET, FILM COATEDANDA202489c8169a92-39e3-4794-87f5-13d31f0f15b3
3400320550ANDANovel Laboratories, Inc.2012-04-30TINIDAZOLEORALTABLETANDA2020444e03b4ac-c88a-4044-9d58-0cfcda3db53c
4427990207ANDAEdenbridge Pharmaceuticals, Llc2015-08-10TINIDAZOLEORALTABLETANDA2038086f3ce597-64c1-4204-a67a-8b6f6e7e8bca
5433860550ANDAGavis Pharmaceuticals, Llc2012-04-30TINIDAZOLEORALTABLETANDA20204495ab57b2-5d7e-4986-abcd-65edf1728383
6445230425NDA AUTHORIZED GENERICBiocomp Pharma, Inc.2012-06-07TINIDAZOLEORALTABLETNDA021618f55bcc41-2e8d-4ee5-9993-05c7d86f2d2c

tinidazole 500 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001788500TindamaxNDAMission Pharmacal Company2004-05-17TINIDAZOLEORALTABLET, FILM COATEDNDA021618a0d01539-8413-4703-94cc-d221918630a1

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000540348ANDARoxane Laboratories, Inc2012-04-30TINIDAZOLEORALTABLET, FILM COATEDANDA2011724d5ea1c2-6126-432f-be61-44fb24d67b7e
2165710215ANDAPack Pharmaceuticals Llc2013-10-09TINIDAZOLEORALTABLET, FILM COATEDANDA202489c8169a92-39e3-4794-87f5-13d31f0f15b3
3400320551ANDANovel Laboratories, Inc.2012-04-30TINIDAZOLEORALTABLETANDA2020444e03b4ac-c88a-4044-9d58-0cfcda3db53c
4427990208ANDAEdenbridge Pharmaceuticals, Llc2015-08-10TINIDAZOLEORALTABLETANDA2038086f3ce597-64c1-4204-a67a-8b6f6e7e8bca
5433860551ANDAGavis Pharmaceuticals, Llc2012-04-30TINIDAZOLEORALTABLETANDA20204495ab57b2-5d7e-4986-abcd-65edf1728383
6445230450NDA AUTHORIZED GENERICBiocomp Pharma, Inc.2012-06-07TINIDAZOLEORALTABLETNDA021618f55bcc41-2e8d-4ee5-9993-05c7d86f2d2c

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548686155TindamaxNDAPhysicians Total Care, Inc.2010-08-23TINIDAZOLEORALTABLET, FILM COATED00178850020NDA021618bc5aaeb2-a7c3-4ff5-a2be-4eaf162453fb

application(s)

#idtitleapplicantapprovedapproved drug
1ANDA201172TINIDAZOLEROXANE LABORATORIES INC2012-04-30ANDA201172_001, ANDA201172_002
2ANDA202044TINIDAZOLENOVEL LABORATORIES INC2012-04-30ANDA202044_001, ANDA202044_002
3ANDA202489TINIDAZOLEUNIQUE PHARMACEUTICAL LABORATORIES2013-10-09ANDA202489_001, ANDA202489_002
4ANDA203808TINIDAZOLEEDENBRIDGE PHARMACEUTICALS LLC2015-08-04ANDA203808_001, ANDA203808_002
5NDA021618TINDAMAXMISSION PHARMACAL CO2004-05-17NDA021618_001, NDA021618_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA201172_001RXTINIDAZOLE (250MG)ORALTABLETFalseAB2012-04-30TINIDAZOLE
2ANDA201172_002RXTINIDAZOLE (500MG)ORALTABLETFalseAB2012-04-30TINIDAZOLE
3ANDA202044_001RXTINIDAZOLE (250MG)ORALTABLETFalseAB2012-04-30TINIDAZOLE
4ANDA202044_002RXTINIDAZOLE (500MG)ORALTABLETFalseAB2012-04-30TINIDAZOLE
5ANDA202489_001RXTINIDAZOLE (250MG)ORALTABLETFalseAB2013-10-09TINIDAZOLE
6ANDA202489_002RXTINIDAZOLE (500MG)ORALTABLETFalseAB2013-10-09TINIDAZOLE
7ANDA203808_001RXTINIDAZOLE (250MG)ORALTABLETFalseAB2015-08-04TINIDAZOLE
8ANDA203808_002RXTINIDAZOLE (500MG)ORALTABLETFalseAB2015-08-04TINIDAZOLE
9NDA021618_001RXTINIDAZOLE (250MG)ORALTABLETFalseAB2004-05-17TINDAMAX
10NDA021618_002RXTINIDAZOLE (500MG)ORALTABLETTrueAB2004-05-17TINDAMAX

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
14d5ea1c2-6126-432f-be61-44fb24d67b7e (view SPL)These highlights do not include all the information needed to use Tinidazole Tablets safely and effectively. See full prescribing information for Tinidazole Tablets.Tinidazole Tablets for oral use Initial U.S. Approval: 2004prescriptionHuman PrescriptionRoxane Laboratories, IncAPI MANUFACTURE, MANUFACTURE2012-05-011000540347, 000540348
24e03b4ac-c88a-4044-9d58-0cfcda3db53c (view SPL)Tinidazole Tablets Novel Laboratories, Inc.These highlights do not include all the information needed to use Tinidazole safely and effectively. See full prescribing information for Tinidazole. Tinidazole (Tinidazole) TABLET for ORAL use.Initial U.S. Approval: 2004prescriptionHuman PrescriptionNovel Laboratories, Inc.ANALYSIS, MANUFACTURE2012-05-253400320550, 400320551
36f3ce597-64c1-4204-a67a-8b6f6e7e8bca (view SPL)Tinidazole tablets for oral useThese highlights do not include all the information needed to use tinidazole tablets safely and effectively. See full prescribing information for tinidazole tablets.Initial U.S. Approval: 2004prescriptionHuman PrescriptionEdenbridge Pharmaceuticals, Llc2015-08-073427990207, 427990208
495ab57b2-5d7e-4986-abcd-65edf1728383 (view SPL)Tinidazole Tablets GAVIS Pharmaceuticals, LLCThese highlights do not include all the information needed to use Tinidazole safely and effectively. See full prescribing information for Tinidazole. Tinidazole (Tinidazole) TABLET for ORAL use.Initial U.S. Approval: 2004prescriptionHuman PrescriptionGavis Pharmaceuticals, LlcANALYSIS, MANUFACTURE2012-05-241433860550, 433860551
5a0d01539-8413-4703-94cc-d221918630a1 (view SPL)Tindamax (tinidazole) oral tabletsThese highlights do not include all the information needed to use Tindamax safely and effectively. See full prescribing information for Tindamax. Tindamax (tinidazole) oral tablets for oral solution. Initial U.S. Approval 2004prescriptionHuman PrescriptionMission Pharmacal CompanyMANUFACTURE2013-07-263001788250, 001788500
6bc5aaeb2-a7c3-4ff5-a2be-4eaf162453fb (view SPL)These highlights do not include all the information needed to use tindamax safely and effectively. See full prescribing information for tindamax. tindamax (Tinidazole) tablet, film coated for oral use Initial U.S. Approval: 2004prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2010-08-301548686155
7c8169a92-39e3-4794-87f5-13d31f0f15b3 (view SPL)These highlights do not include all the information needed to use Tinidazole Tablets safely and effectively. See full prescribing information for Tinidazole Tablets Tinidazole Tablets, for oral use Initial U.S. Approval: 2004prescriptionHuman PrescriptionPack Pharmaceuticals Llc2013-12-302165710214, 165710215
8f55bcc41-2e8d-4ee5-9993-05c7d86f2d2c (view SPL)These highlights do not include all the information needed to use tinidazole safely and effectively. See full prescribing information for tinidazole. Tinidazole tablets for oral use Initial U.S. Approval: 2004prescriptionHuman PrescriptionBiocomp Pharma, Inc.MANUFACTURE2012-06-051445230425, 445230450

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