FDA.reportPublic FDA data

Application 091382

Type
ANDA
Sponsor
SUN PHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LIOTHYRONINE SODIUMLIOTHYRONINE SODIUMTABLET;ORALEQ 0.005MG BASENoNo
002LIOTHYRONINE SODIUMLIOTHYRONINE SODIUMTABLET;ORALEQ 0.025MG BASENoNo
003LIOTHYRONINE SODIUMLIOTHYRONINE SODIUMTABLET;ORALEQ 0.05MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
60687-625liothyronine sodiumliothyronine sodiumAmerican Health PackagingANDACurrent
62756-589liothyronine sodiumliothyronine sodiumSun Pharmaceutical Industries, Inc.ANDACurrent
62756-589liothyronine sodiumliothyronine sodiumSun Pharmaceutical Industries, Inc.ANDACurrent
62756-590liothyronine sodiumliothyronine sodiumSun Pharmaceutical Industries, Inc.ANDACurrent
62756-590liothyronine sodiumliothyronine sodiumSun Pharmaceutical Industries, Inc.ANDACurrent
62756-591liothyronine sodiumliothyronine sodiumSun Pharmaceutical Industries, Inc.ANDACurrent
62756-591liothyronine sodiumliothyronine sodiumSun Pharmaceutical Industries, Inc.ANDACurrent
63629-8337liothyronine sodiumliothyronine sodiumBryant Ranch PrepackANDACurrent
63629-8337liothyronine sodiumliothyronine sodiumBryant Ranch PrepackANDACurrent
63629-8337liothyronine sodiumliothyronine sodiumBryant Ranch PrepackANDACurrent
71335-1671liothyronine sodiumliothyronine sodiumBryant Ranch PrepackANDACurrent
71335-1671liothyronine sodiumliothyronine sodiumBryant Ranch PrepackANDACurrent
71335-1671liothyronine sodiumliothyronine sodiumBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
31526ORIG2016-04-22