FDA.report

Application 209743

Type
ANDA
Sponsor
AMNEAL PHARMS CO

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001PREGABALINPREGABALINCAPSULE;ORAL25MGNoNo
002PREGABALINPREGABALINCAPSULE;ORAL50MGNoNo
003PREGABALINPREGABALINCAPSULE;ORAL75MGNoNo
004PREGABALINPREGABALINCAPSULE;ORAL100MGNoNo
005PREGABALINPREGABALINCAPSULE;ORAL150MGNoNo
006PREGABALINPREGABALINCAPSULE;ORAL200MGNoNo
007PREGABALINPREGABALINCAPSULE;ORAL225MGNoNo
008PREGABALINPREGABALINCAPSULE;ORAL300MGNoNo

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
60219-1310PregabalinPregabalinAmneal Pharmaceuticals NY LLCANDACurrent
60219-1310PregabalinPregabalinAmneal Pharmaceuticals NY LLCANDACurrent
60219-1311PregabalinPregabalinAmneal Pharmaceuticals NY LLCANDACurrent
60219-1311PregabalinPregabalinAmneal Pharmaceuticals NY LLCANDACurrent
60219-1312PregabalinPregabalinAmneal Pharmaceuticals NY LLCANDACurrent
60219-1312PregabalinPregabalinAmneal Pharmaceuticals NY LLCANDACurrent
60219-1313PregabalinPregabalinAmneal Pharmaceuticals NY LLCANDACurrent
60219-1313PregabalinPregabalinAmneal Pharmaceuticals NY LLCANDACurrent
60219-1314PregabalinPregabalinAmneal Pharmaceuticals NY LLCANDACurrent
60219-1314PregabalinPregabalinAmneal Pharmaceuticals NY LLCANDACurrent
60219-1315PregabalinPregabalinAmneal Pharmaceuticals NY LLCANDACurrent
60219-1315PregabalinPregabalinAmneal Pharmaceuticals NY LLCANDACurrent
60219-1316PregabalinPregabalinAmneal Pharmaceuticals NY LLCANDACurrent
60219-1316PregabalinPregabalinAmneal Pharmaceuticals NY LLCANDACurrent
60219-1317PregabalinPregabalinAmneal Pharmaceuticals NY LLCANDACurrent
60219-1317PregabalinPregabalinAmneal Pharmaceuticals NY LLCANDACurrent
69238-1310PregabalinPregabalinAmneal Pharmaceuticals NY LLCANDACurrent
69238-1310PregabalinPregabalinAmneal Pharmaceuticals NY LLCANDACurrent
69238-1310PregabalinPregabalinAmneal Pharmaceuticals NY LLCANDACurrent
69238-1311PregabalinPregabalinAmneal Pharmaceuticals NY LLCANDACurrent
69238-1311PregabalinPregabalinAmneal Pharmaceuticals NY LLCANDACurrent
69238-1311PregabalinPregabalinAmneal Pharmaceuticals NY LLCANDACurrent
69238-1312PregabalinPregabalinAmneal Pharmaceuticals NY LLCANDACurrent
69238-1312PregabalinPregabalinAmneal Pharmaceuticals NY LLCANDACurrent
69238-1312PregabalinPregabalinAmneal Pharmaceuticals NY LLCANDACurrent
69238-1313PregabalinPregabalinAmneal Pharmaceuticals NY LLCANDACurrent
69238-1313PregabalinPregabalinAmneal Pharmaceuticals NY LLCANDACurrent
69238-1313PregabalinPregabalinAmneal Pharmaceuticals NY LLCANDACurrent
69238-1314PregabalinPregabalinAmneal Pharmaceuticals NY LLCANDACurrent
69238-1314PregabalinPregabalinAmneal Pharmaceuticals NY LLCANDACurrent
69238-1314PregabalinPregabalinAmneal Pharmaceuticals NY LLCANDACurrent
69238-1315PregabalinPregabalinAmneal Pharmaceuticals NY LLCANDACurrent
69238-1315PregabalinPregabalinAmneal Pharmaceuticals NY LLCANDACurrent
69238-1315PregabalinPregabalinAmneal Pharmaceuticals NY LLCANDACurrent
69238-1316PregabalinPregabalinAmneal Pharmaceuticals NY LLCANDACurrent
69238-1316PregabalinPregabalinAmneal Pharmaceuticals NY LLCANDACurrent
69238-1316PregabalinPregabalinAmneal Pharmaceuticals NY LLCANDACurrent
69238-1317PregabalinPregabalinAmneal Pharmaceuticals NY LLCANDACurrent
69238-1317PregabalinPregabalinAmneal Pharmaceuticals NY LLCANDACurrent
69238-1317PregabalinPregabalinAmneal Pharmaceuticals NY LLCANDACurrent
70518-2364PregabalinPregabalinREMEDYREPACK INC.ANDACurrent
70518-2364PregabalinPregabalinREMEDYREPACK INC.ANDACurrent
70518-2364PregabalinPregabalinREMEDYREPACK INC.ANDACurrent
70518-2364PregabalinPregabalinREMEDYREPACK INC.ANDACurrent
70518-2364PregabalinPregabalinREMEDYREPACK INC.ANDACurrent
70518-2483PregabalinPregabalinREMEDYREPACK INC.ANDACurrent
70518-2483PregabalinPregabalinREMEDYREPACK INC.ANDACurrent
70518-2483PregabalinPregabalinREMEDYREPACK INC.ANDACurrent
70518-2483PregabalinPregabalinREMEDYREPACK INC.ANDACurrent
70518-2571PregabalinPregabalinREMEDYREPACK INC.ANDACurrent
70518-2571PregabalinPregabalinREMEDYREPACK INC.ANDACurrent
70518-2571PregabalinPregabalinREMEDYREPACK INC.ANDACurrent
70518-2571PregabalinPregabalinREMEDYREPACK INC.ANDACurrent
70518-2571PregabalinPregabalinREMEDYREPACK INC.ANDACurrent
70518-2948PregabalinPregabalinREMEDYREPACK INC.ANDACurrent
70518-2948PregabalinPregabalinREMEDYREPACK INC.ANDACurrent
70518-2948PregabalinPregabalinREMEDYREPACK INC.ANDACurrent
70518-2948PregabalinPregabalinREMEDYREPACK INC.ANDACurrent
70518-2978PregabalinPregabalinREMEDYREPACK INC.ANDACurrent
70518-2978PregabalinPregabalinREMEDYREPACK INC.ANDACurrent
70518-2980PregabalinPregabalinREMEDYREPACK INC.ANDACurrent
70518-2980PregabalinPregabalinREMEDYREPACK INC.ANDACurrent
72189-028PREGABALINPREGABALINDirect_RxANDACurrent
72189-028PREGABALINPREGABALINDirect_RxANDACurrent
72189-028PREGABALINPREGABALINDirect_RxANDACurrent
72189-032PREGABALINPREGABALINDirect_RxANDACurrent
72189-032PREGABALINPREGABALINDirect_RxANDACurrent
72189-032PREGABALINPREGABALINDirect_RxANDACurrent
72189-033PREGABALINPREGABALINDirect_RxANDACurrent
72189-033PREGABALINPREGABALINDirect_RxANDACurrent
72189-033PREGABALINPREGABALINDirect_RxANDACurrent
72189-033PREGABALINPREGABALINDirect_RxANDACurrent
72189-033PREGABALINPREGABALINDirect_RxANDACurrent
72189-033PREGABALINPREGABALINDirect_RxANDACurrent
72189-033PREGABALINPREGABALINDirect_RxANDACurrent
72189-033PREGABALINPREGABALINDirect_RxANDACurrent
72189-033PREGABALINPREGABALINDirect_RxANDACurrent
72189-033PREGABALINPREGABALINDirect_RxANDACurrent
72189-034PREGABALINPREGABALINDirect_RxANDACurrent
72189-034PREGABALINPREGABALINDirect_RxANDACurrent