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#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 12 · 222 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-73effbe0d0542026-07-01Warnings, 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
PregabalinPREGABALINREMEDYREPACK INC.d095accf-9cea-4948-b43d-ae1b8fbce7c22026-06-11Warnings, 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

Documents#

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