FDA.reportPublic FDA data

Application 212865

Type
ANDA
Sponsor
CELLTRION

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PREGABALINPREGABALINCAPSULE;ORAL50MGNoNo
002PREGABALINPREGABALINCAPSULE;ORAL75MGNoNo
003PREGABALINPREGABALINCAPSULE;ORAL100MGNoNo
004PREGABALINPREGABALINCAPSULE;ORAL150MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
71335-2000PregabalinpregabalinBryant Ranch PrepackANDACurrent
71335-2012PregabalinpregabalinBryant Ranch PrepackANDACurrent
71335-2015PregabalinpregabalinBryant Ranch PrepackANDACurrent
71335-2030PregabalinpregabalinBryant Ranch PrepackANDACurrent
72606-005PregabalinpregabalinCELLTRION USA, INC.ANDACurrent
72606-005PregabalinpregabalinCELLTRION USA, INC.ANDACurrent
72606-006PregabalinpregabalinCELLTRION USA, INC.ANDACurrent
72606-006PregabalinpregabalinCELLTRION USA, INC.ANDACurrent
72606-007PregabalinpregabalinCELLTRION USA, INC.ANDACurrent
72606-007PregabalinpregabalinCELLTRION USA, INC.ANDACurrent
72606-008PregabalinpregabalinCELLTRION USA, INC.ANDACurrent
72606-008PregabalinpregabalinCELLTRION USA, INC.ANDACurrent
76420-221PregabalinpregabalinAsclemed USA, Inc.ANDACurrent
76420-221PregabalinpregabalinAsclemed USA, Inc.ANDACurrent
76420-247PregabalinpregabalinAsclemed USA, Inc.ANDACurrent
76420-247PregabalinpregabalinAsclemed USA, Inc.ANDACurrent
76420-248PregabalinpregabalinAsclemed USA, Inc.ANDACurrent
76420-249PregabalinpregabalinAsclemed USA, Inc.ANDACurrent
76420-249PregabalinpregabalinAsclemed USA, Inc.ANDACurrent
80425-0166LyricaPregabalin 100mgAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0166PregabalinPregabalinAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0166PregabalinPregabalinAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent