FDA.reportPublic FDA data

Application 211384

Type
ANDA
Sponsor
INVAGEN PHARMS

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-5177PregabalinPREGABALINA-S Medication SolutionsANDACurrent
69097-954PregabalinPREGABALINCipla USA, Inc.ANDACurrent
69097-954PregabalinPREGABALINCipla USA, Inc.ANDACurrent
69097-955PregabalinPREGABALINCipla USA, Inc.ANDACurrent
69097-955PregabalinPREGABALINCipla USA, Inc.ANDACurrent
69097-956PregabalinPREGABALINCipla USA, Inc.ANDACurrent
69097-956PregabalinPREGABALINCipla USA, Inc.ANDACurrent
69097-957PregabalinPREGABALINCipla USA, Inc.ANDACurrent
69097-957PregabalinPREGABALINCipla USA, Inc.ANDACurrent
69097-958PregabalinPREGABALINCipla USA, Inc.ANDACurrent
69097-958PregabalinPREGABALINCipla USA, Inc.ANDACurrent
69097-959PregabalinPREGABALINCipla USA, Inc.ANDACurrent
69097-959PregabalinPREGABALINCipla USA, Inc.ANDACurrent
69097-961PregabalinPREGABALINCipla USA, Inc.ANDACurrent
69097-961PregabalinPREGABALINCipla USA, Inc.ANDACurrent
69097-962PregabalinPREGABALINCipla USA, Inc.ANDACurrent
69097-962PregabalinPREGABALINCipla USA, Inc.ANDACurrent
71610-313PregabalinPREGABALINAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-314PregabalinPREGABALINAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-315PregabalinPREGABALINAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-316PregabalinPREGABALINAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-317PregabalinPREGABALINAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-318PregabalinPREGABALINAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-319PregabalinPREGABALINAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-320PregabalinPREGABALINAphena Pharma Solutions - Tennessee, LLCANDACurrent
76282-568PregabalinPREGABALINExelan Pharmaceuticals Inc.ANDACurrent
76282-568PregabalinPREGABALINExelan Pharmaceuticals Inc.ANDACurrent
76282-569PregabalinPREGABALINExelan Pharmaceuticals Inc.ANDACurrent
76282-569PregabalinPREGABALINExelan Pharmaceuticals Inc.ANDACurrent
76282-570PregabalinPREGABALINExelan Pharmaceuticals Inc.ANDACurrent
76282-570PregabalinPREGABALINExelan Pharmaceuticals Inc.ANDACurrent
76282-571PregabalinPREGABALINExelan Pharmaceuticals Inc.ANDACurrent
76282-571PregabalinPREGABALINExelan Pharmaceuticals Inc.ANDACurrent
76282-572PregabalinPREGABALINExelan Pharmaceuticals Inc.ANDACurrent
76282-572PregabalinPREGABALINExelan Pharmaceuticals Inc.ANDACurrent
76282-573PregabalinPREGABALINExelan Pharmaceuticals Inc.ANDACurrent
76282-573PregabalinPREGABALINExelan Pharmaceuticals Inc.ANDACurrent
76282-574PregabalinPREGABALINExelan Pharmaceuticals Inc.ANDACurrent
76282-574PregabalinPREGABALINExelan Pharmaceuticals Inc.ANDACurrent
76282-575PregabalinPREGABALINExelan Pharmaceuticals Inc.ANDACurrent
76282-575PregabalinPREGABALINExelan Pharmaceuticals Inc.ANDACurrent