FDA.reportPublic FDA data

Application 201510

Type
ANDA
Sponsor
LUPIN LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PIRMELLA 7/7/7ETHINYL ESTRADIOL; NORETHINDRONETABLET;ORAL-280.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68180-892PIRMELLA 7/7/7NORETHINDRONE AND ETHINYL ESTRADIOLLupin Pharmaceuticals, Inc.ANDACurrent
68180-892PIRMELLA 7/7/7NORETHINDRONE AND ETHINYL ESTRADIOLLupin Pharmaceuticals, Inc.ANDACurrent
68180-892PIRMELLA 7/7/7NORETHINDRONE AND ETHINYL ESTRADIOLLupin Pharmaceuticals, Inc.ANDACurrent
68180-892PIRMELLA 7/7/7NORETHINDRONE AND ETHINYL ESTRADIOLLupin Pharmaceuticals, Inc.ANDACurrent
68180-892PIRMELLA 7/7/7NORETHINDRONE AND ETHINYL ESTRADIOLLupin Pharmaceuticals, Inc.ANDACurrent
76413-150PIRMELLA 7/7/7NORETHINDRONE AND ETHINYL ESTRADIOLCentral Texas Community Health CentersANDACurrent