FDA.reportPublic FDA data

Application 202489

Type
ANDA
Sponsor
UNIQUE PHARM LABS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TINIDAZOLETINIDAZOLETABLET;ORAL250MGNoNo
002TINIDAZOLETINIDAZOLETABLET;ORAL500MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16571-214TindazoleTinidazolePack Pharmaceuticals, LLCANDACurrent
16571-215TindazoleTinidazolePack Pharmaceuticals, LLCANDACurrent
64980-426TindazoleTinidazoleRising Pharmaceuticals, Inc.ANDACurrent
64980-426TindazoleTinidazoleRising Pharmaceuticals, Inc.ANDACurrent
64980-426TindazoleTinidazoleRising Pharmaceuticals, Inc.ANDACurrent
64980-427TindazoleTinidazoleRising Pharmaceuticals, Inc.ANDACurrent
64980-427TindazoleTinidazoleRising Pharmaceuticals, Inc.ANDACurrent
64980-427TindazoleTinidazoleRising Pharmaceuticals, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
40187SUPPL2013-11-20
32266SUPPL2013-10-11