FDA.reportPublic FDA data

Application 214684

Type
ANDA
Sponsor
UNIQUE PHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LORATADINELORATADINETABLET;ORAL10MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16571-822LoratadineloratadineRising Pharmaceuticals, IncANDACurrent
68210-4126LoratadineLoratadineSpirit Pharmaceuticals LLCANDACurrent
68210-4126LoratadineLoratadineSpirit Pharmaceuticals LLCANDACurrent
68210-4126LoratadineLoratadineSpirit Pharmaceuticals LLCANDACurrent
70677-0134LoratadineLoratadineStrategic Sourcing Services, LLCANDACurrent
70677-0134LoratadineLoratadineStrategic Sourcing Services, LLCANDACurrent
70677-0134LoratadineLoratadineStrategic Sourcing Services, LLCANDACurrent
70677-0134LoratadineLoratadineStrategic Sourcing Services, LLCANDACurrent
70985-017LoratadineLoratadineDRUG OCEAN LLCANDACurrent
82501-1580LoratadineLoratadineGobrands, IncANDACurrent