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

Source provenance: Browse the complete Orange Book source catalog.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 12 of 12 · 226 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PregabalinPREGABALINProficient Rx LPd58c0808-2ff9-4ce6-9c07-56f7235923852022-04-01Warnings, Adverse reactionsName fallback
generic name: PREGABALIN
PregabalinPREGABALINProficient Rx LPa0f2b8af-0a04-4db0-adb3-d9d9369223d92022-04-01Warnings, Adverse reactionsName fallback
generic name: PREGABALIN
PREGABALINPREGABALINAsclemed USA, Inc.69b8a843-a3a8-4d76-8418-f482886250302020-06-25Warnings, Adverse reactionsName fallback
generic name: PREGABALIN
LyricaPREGABALINParke-Davis Div of Pfizer Inc60185c88-ecfd-46f9-adb9-b97c6b00a5532020-06-15Warnings, Adverse reactionsName fallback
brand name: Lyrica
generic name: PREGABALIN
PREGABALINPREGABALINProficient Rx LP4624c58f-8f77-48fa-be0f-fca4010cc8ae2019-10-01Warnings, Adverse reactionsName fallback
generic name: PREGABALIN
PREGABALINPREGABALINProficient Rx LP6022939f-92a8-4cb4-9f04-f237a4d73f6f2019-10-01Warnings, Adverse reactionsName fallback
generic name: PREGABALIN

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 29 matching rows.

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