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 2 of 12 · 226 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PregabalinPREGABALINREMEDYREPACK INC.91edbe87-cd22-43a5-9952-1cd523b138202026-07-29Warnings, Adverse reactionsName fallback
generic name: PREGABALIN
PregabalinPREGABALINREMEDYREPACK INC.14f3f9ba-7a4a-45d5-a25e-efe5cdff117d2026-07-28Warnings, Adverse reactionsName fallback
generic name: PREGABALIN
PregabalinPREGABALINREMEDYREPACK INC.44ec2918-4e0c-4e2d-9157-81295a15df572026-07-28Warnings, Adverse reactionsName fallback
generic name: PREGABALIN
PregabalinPREGABALINBryant Ranch Prepack1e6fa742-f658-495f-88bb-8eddf9a45ffe2026-07-27Warnings, Adverse reactionsName fallback
generic name: PREGABALIN
PregabalinPREGABALINBryant Ranch Prepack48798c13-3ef4-4e7f-9f73-92dccac0af142026-07-24Warnings, Adverse reactionsName fallback
generic name: PREGABALIN
PREGABALINPREGABALINCardinal Health 107, LLC124176c7-d8ab-4bbe-b468-3e5d12f03e442026-07-21Warnings, Adverse reactionsName fallback
generic name: PREGABALIN
PregabalinPREGABALINSt. Mary's Medical Park Pharmacyfc5dd378-950f-949b-e053-6394a90a3ca22026-07-17Warnings, Adverse reactionsName fallback
generic name: PREGABALIN
PregabalinPREGABALINSt. Mary's Medical Park Pharmacy9235cd08-7a25-4b81-e053-2995a90a539c2026-07-02Warnings, Adverse reactionsName fallback
generic name: PREGABALIN
PregabalinPREGABALINProficient Rx LP189b610e-3e29-42fa-ab6e-73effbe0d0542026-07-02Warnings, Adverse reactionsName fallback
generic name: PREGABALIN
PregabalinPREGABALINSt. Mary's Medical Park Pharmacy35d3486c-c6ea-4d31-e063-6294a90a12192026-06-30Warnings, Adverse reactionsName fallback
generic name: PREGABALIN
PregabalinPREGABALINSt. Mary's Medical Park Pharmacy35d387dd-bc7f-37a4-e063-6394a90abbbb2026-06-30Warnings, Adverse reactionsName fallback
generic name: PREGABALIN
PregabalinPREGABALINSt. Mary's Medical Park Pharmacy36c3dda1-67fb-4dc5-e063-6294a90a1c3e2026-06-26Warnings, Adverse reactionsName fallback
generic name: PREGABALIN
PregabalinPREGABALINSt. Mary's Medical Park Pharmacy2c62e63a-fe81-a463-e063-6394a90a65ee2026-06-26Warnings, Adverse reactionsName fallback
generic name: PREGABALIN
PregabalinPREGABALINSt. Mary's Medical Park Pharmacy2e6e6f9c-a14c-2d75-e063-6294a90a827e2026-06-20Warnings, Adverse reactionsName fallback
generic name: PREGABALIN
PregabalinPREGABALINREMEDYREPACK INC.ba3006b7-991f-4ae0-b908-5910e827e5bf2026-06-12Warnings, Adverse reactionsName fallback
generic name: PREGABALIN
PregabalinPREGABALINClinical Solutions Wholesale, LLC150c8b71-98b0-4c6b-b20f-fd0fca2d3c262026-06-11Warnings, Adverse reactionsName fallback
generic name: PREGABALIN
PREGABALINPREGABALINNovadoz Pharmaceuticals LLCf6aa5977-97c8-4a56-8e35-d9ab5cc243692026-06-10Warnings, Adverse reactionsName fallback
generic name: PREGABALIN
PregabalinPREGABALINCoupler LLC5383c0de-0c85-f702-e063-6294a90a1d8d2026-06-05Warnings, Adverse reactionsName fallback
generic name: PREGABALIN
PregabalinPREGABALINST. MARY'S MEDICAL PARK PHARMACY923743f0-f557-9143-e053-2a95a90a21ae2026-06-05Warnings, Adverse reactionsName fallback
generic name: PREGABALIN
PregabalinPREGABALINA-S Medication Solutionsb740832a-6e90-4b20-bfed-be0415f1aebe2026-06-03Warnings, 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