FDA.reportPublic FDA data

Application 021724

Type
NDA
Sponsor
CP PHARMS

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
21695-276LyricaPREGABALINRebel Distributors CorpNDACurrent
21695-277LyricaPREGABALINRebel Distributors CorpNDACurrent
21695-278LyricaPREGABALINRebel Distributors CorpNDACurrent
21695-661LyricaPREGABALINRebel Distributors CorpNDACurrent
21695-662LyricaPREGABALINRebel Distributors CorpNDACurrent
21695-663LyricaPREGABALINRebel Distributors CorpNDACurrent
35356-053LyricaPREGABALINLake Erie Medical Surgical & Supply DBA Quality Care Products LLCNDACurrent
35356-054LyricaPREGABALINQuality Care Products, LLCNDA AUTHORIZED GENERICCurrent
35356-398LyricaPregabalinLake Erie Medical DBA Quality Care Products LLCNDACurrent
42254-134LyricaPREGABALINRebel Distributors CorpNDACurrent
49999-905LyricaPREGABALINQuality Care Products, LLCNDACurrent
49999-905LyricaPREGABALINQuality Care Products, LLCNDACurrent
49999-906LyricaPregabalinLake Erie Medical DBA QuaNDACurrent
52959-746LyricaPREGABALINH.J. Harkins Company, Inc.NDACurrent
52959-747LyricaPREGABALINH.J. Harkins Company, Inc.NDACurrent
52959-891LyricaPREGABALINH.J. Harkins Company, Inc.NDACurrent
52959-897LyricaPREGABALINH.J. Harkins Company, Inc.NDACurrent
55154-2430LyricapregabalinCardinal HealthNDACurrent
55154-2430LyricapregabalinCardinal HealthNDACurrent
55154-2430LyricapregabalinCardinal HealthNDACurrent
55154-2430LyricapregabalinCardinal Health 107, LLCNDACurrent
55154-2431LyricapregabalinCardinal HealthNDACurrent
55154-2431LyricapregabalinCardinal HealthNDACurrent
55154-2431LyricapregabalinCardinal HealthNDACurrent
55154-2431LyricapregabalinCardinal Health 107, LLCNDACurrent
63539-013LyricaPREGABALINU.S. PharmaceuticalsNDACurrent
63539-014LyricaPREGABALINU.S. PharmaceuticalsNDACurrent
68258-7047LyricaPREGABALINDispensing Solutions, Inc.NDACurrent
68258-7980LyricaPREGABALINDispensing Solutions, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
21793ORIG2008-01-23
44611ORIG2005-11-30
6058ORIG2005-06-14