FDA.reportPublic FDA data

Application 073039

Type
ANDA
Sponsor
MYLAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SULINDACSULINDACTABLET;ORAL200MGNoNo
002SULINDACSULINDACTABLET;ORAL150MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-0427SulindacsulindacMylan Pharmaceuticals Inc.ANDACurrent
0378-0427SulindacsulindacMylan Pharmaceuticals Inc.ANDACurrent
0378-0427SulindacsulindacMylan Pharmaceuticals Inc.ANDACurrent
0378-0427SulindacsulindacMylan Pharmaceuticals Inc.ANDACurrent
0378-0531SulindacsulindacMylan Pharmaceuticals Inc.ANDACurrent
0378-0531SulindacsulindacMylan Pharmaceuticals Inc.ANDACurrent
0378-0531SulindacsulindacMylan Pharmaceuticals Inc.ANDACurrent
0378-0531SulindacsulindacMylan Pharmaceuticals Inc.ANDACurrent
51079-667SulindacsulindacMylan Institutional Inc.ANDACurrent
51079-667SulindacsulindacMylan Institutional Inc.ANDACurrent
51079-667SulindacsulindacMylan Institutional Inc.ANDACurrent