FDA.reportPublic FDA data

Application 021723

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 7 of 12 · 226 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PregabalinPREGABALINAphena Pharma Solutions - Tennessee, LLC3e9cfeb9-1e2b-ea79-e063-6394a90a67b12025-09-12Warnings, Adverse reactionsName fallback
generic name: PREGABALIN
PregabalinPREGABALINPreferred Pharmaceuticals Inc.e8e272a4-c181-4573-822b-2bb315b6ad372025-09-12Warnings, Adverse reactionsName fallback
generic name: PREGABALIN
PREGABALINPREGABALINCadila Pharmaceuticals Limited170c0c95-2ee8-4dff-bbd6-b87a21e8cf812025-09-12Warnings, Adverse reactionsName fallback
generic name: PREGABALIN
PregabalinPREGABALINPreferred Pharmaceuticals, Inc.ceedde96-fdaf-4708-9ca1-e48e052cde752025-09-12Warnings, Adverse reactionsName fallback
generic name: PREGABALIN
PregabalinPREGABALINPreferred Pharmaceuticals Inc.a0da0534-b386-4c93-ae89-03b0e3325e022025-09-11Warnings, Adverse reactionsName fallback
generic name: PREGABALIN
PregabalinPREGABALINPreferred Pharmaceuticals, Inc.1760ccdc-46f7-4182-a563-96b13212cb7e2025-09-11Warnings, Adverse reactionsName fallback
generic name: PREGABALIN
PregabalinPREGABALINPreferred Pharmaceuticals, Inc.3dbfd868-8408-4514-ba1c-04a5d095c16a2025-09-10Warnings, Adverse reactionsName fallback
generic name: PREGABALIN
PregabalinPREGABALINAphena Pharma Solutions - Tennessee, LLC31e7caf6-0a8b-f343-e063-6294a90ad7292025-09-08Warnings, Adverse reactionsName fallback
generic name: PREGABALIN
PREGABALINPREGABALINRising Pharma Holdings, Inc.dbebfa61-0685-41b4-8364-00b8d8b737142025-09-05Warnings, Adverse reactionsName fallback
generic name: PREGABALIN
PregabalinPREGABALINNovadoz Pharmaceuticals LLC193666f7-3c55-43b1-947a-2ffec40c687f2025-08-28Warnings, Adverse reactionsName fallback
generic name: PREGABALIN
pregabalinPREGABALINIndoco Remedies Limited0a8d9e35-46fd-4c70-bb7f-4e8b754f27942025-08-25Warnings, Adverse reactionsName fallback
generic name: PREGABALIN
PregabalinPREGABALINAphena Pharma Solutions - Tennessee, LLC3c6daa12-5284-d9f1-e063-6294a90ae0602025-08-15Warnings, Adverse reactionsName fallback
generic name: PREGABALIN
PregabalinPREGABALINAlembic Pharmaceuticals Inc.cf7b4b67-b017-47ac-af3f-bde5bd07bb0c2025-07-29Warnings, Adverse reactionsName fallback
generic name: PREGABALIN
PregabalinPREGABALINAphena Pharma Solutions - Tennessee, LLC3ab4efb3-1ae5-2504-e063-6294a90a6d1d2025-07-24Warnings, Adverse reactionsName fallback
generic name: PREGABALIN
PregabalinPREGABALINAphena Pharma Solutions - Tennessee, LLC3ab57054-02c2-5e28-e063-6294a90a71ab2025-07-24Warnings, Adverse reactionsName fallback
generic name: PREGABALIN
PregabalinPREGABALINAphena Pharma Solutions - Tennessee, LLC3a124f59-38c2-7280-e063-6394a90a43b42025-07-16Warnings, Adverse reactionsName fallback
generic name: PREGABALIN
PregabalinPREGABALINAphena Pharma Solutions - Tennessee, LLC3a1374f4-79dd-ebbc-e063-6394a90a53b02025-07-16Warnings, Adverse reactionsName fallback
generic name: PREGABALIN
PregabalinPREGABALINAphena Pharma Solutions - Tennessee, LLCef7c2e2c-c314-4bfd-a9fa-39f0b0884d342025-07-11Warnings, Adverse reactionsName fallback
generic name: PREGABALIN
PregabalinPREGABALINAmneal Pharmaceuticals NY LLC3099759f-cb24-40e8-b482-9388c38c73b92025-06-19Warnings, Adverse reactionsName fallback
generic name: PREGABALIN
PregabalinPREGABALINMARKSANS PHARMA LIMITEDb2b81bb6-5423-4221-8a61-f70a38d6a1e92025-06-10Warnings, Adverse reactionsName fallback
generic name: PREGABALIN

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
21792ORIG2005-12-02
44610ORIG2005-11-30
28471ORIG2005-01-11