FDA.reportPublic FDA data

Application 210420

Type
ANDA
Sponsor
QILU

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TADALAFILTADALAFILTABLET;ORAL2.5MGNoNo
002TADALAFILTADALAFILTABLET;ORAL5MGNoNo
003TADALAFILTADALAFILTABLET;ORAL10MGNoNo
004TADALAFILTADALAFILTABLET;ORAL20MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
45865-991TadalafilTadalafilmedsource pharmaceuticalsANDACurrent
51293-839TadalafilTadalafilECI Pharmaceuticals, LLCANDACurrent
51293-840TadalafilTadalafilECI Pharmaceuticals, LLCANDACurrent
51293-841TadalafilTadalafilECI Pharmaceuticals, LLCANDACurrent
51293-842TadalafilTadalafilECI Pharmaceuticals, LLCANDACurrent
60505-4683TadalafilTadalafilApotex Corp.ANDACurrent
60505-4683TadalafilTadalafilApotex Corp.ANDACurrent
60505-4683TadalafilTadalafilApotex Corp.ANDACurrent
60505-4684TadalafilTadalafilApotex Corp.ANDACurrent
60505-4684TadalafilTadalafilApotex Corp.ANDACurrent
60505-4684TadalafilTadalafilApotex Corp.ANDACurrent
60505-4685TadalafilTadalafilApotex Corp.ANDACurrent
60505-4685TadalafilTadalafilApotex Corp.ANDACurrent
60505-4685TadalafilTadalafilApotex Corp.ANDACurrent
60505-4686TadalafilTadalafilApotex Corp.ANDACurrent
60505-4686TadalafilTadalafilApotex Corp.ANDACurrent
60505-4686TadalafilTadalafilApotex Corp.ANDACurrent
67184-0523TadalafilTadalafilQilu Pharmaceutical Co., Ltd.ANDACurrent
67184-0523TadalafilTadalafilQilu Pharmaceutical Co., Ltd.ANDACurrent
67184-0524TadalafilTadalafilQilu Pharmaceutical Co., Ltd.ANDACurrent
67184-0524TadalafilTadalafilQilu Pharmaceutical Co., Ltd.ANDACurrent
67184-0525TadalafilTadalafilQilu Pharmaceutical Co., Ltd.ANDACurrent
67184-0525TadalafilTadalafilQilu Pharmaceutical Co., Ltd.ANDACurrent
67184-0526TadalafilTadalafilQilu Pharmaceutical Co., Ltd.ANDACurrent
67184-0526TadalafilTadalafilQilu Pharmaceutical Co., Ltd.ANDACurrent
67184-0526TadalafilTadalafilQilu Pharmaceutical Co., Ltd.ANDACurrent
67184-0526TadalafilTadalafilQilu Pharmaceutical Co., Ltd.ANDACurrent
68071-4912TadalafilTadalafilNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4912TadalafilTadalafilNuCare Pharmaceuticals,Inc.ANDACurrent
71205-400TadalafilTadalafilProficient Rx LPANDACurrent
71335-1372TadalafilTadalafilBryant Ranch PrepackANDACurrent
71335-1372TadalafilTadalafilBryant Ranch PrepackANDACurrent