Application 021618

Type
NDA
Sponsor
MISSION PHARMA

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001TINDAMAXTINIDAZOLETABLET;ORAL250MGYesNo
002TINDAMAXTINIDAZOLETABLET;ORAL500MGYesYes

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
0178-8250TindamaxtinidazoleMission Pharmacal CompanyNDACurrent
0178-8250TindamaxtinidazoleMission Pharmacal CompanyNDACurrent
0178-8250TindamaxtinidazoleMission Pharmacal CompanyNDACurrent
0178-8250TindamaxtinidazoleMission Pharmacal CompanyNDACurrent
0178-8500TindamaxtinidazoleMission Pharmacal CompanyNDACurrent
0178-8500TindamaxtinidazoleMission Pharmacal CompanyNDACurrent
0178-8500TindamaxtinidazoleMission Pharmacal CompanyNDACurrent
0178-8500TindamaxtinidazoleMission Pharmacal CompanyNDACurrent
44523-425TinidazoleTinidazoleBiocomp Pharma, Inc.NDA AUTHORIZED GENERICCurrent
44523-450TinidazoleTinidazoleBiocomp Pharma, Inc.NDA AUTHORIZED GENERICCurrent

Documents

DocumentSubmission typeDate
69679SUPPL2021-12-20
69612SUPPL2021-12-17
64908SUPPL2020-10-14
64897SUPPL2020-10-14
59003SUPPL2019-06-10
59001SUPPL2019-06-10
37343SUPPL2007-05-29
5864SUPPL2007-05-29
42235ORIG2004-08-30
15880ORIG2004-05-27
5863ORIG2004-05-26