FDA.reportPublic FDA data

Application 209250

Type
ANDA
Sponsor
UNICHEM LABS LTD

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
29300-286tadalafiltadalafilUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-286tadalafiltadalafilUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-286tadalafiltadalafilUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-287tadalafiltadalafilUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-287tadalafiltadalafilUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-287tadalafiltadalafilUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-288tadalafiltadalafilUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-288tadalafiltadalafilUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-288tadalafiltadalafilUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-289tadalafiltadalafilUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-289tadalafiltadalafilUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-289tadalafiltadalafilUnichem Pharmaceuticals (USA), Inc.ANDACurrent
73160-010TadalafiltadalafilCarePartners Pharmacy, LLCANDACurrent
73160-015TadalafiltadalafilCarePartners Pharmacy, LLCANDACurrent