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 10 of 12 · 226 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PregabalinPREGABALINBryant Ranch Prepack8923d776-b374-4c06-a208-abeffb1ba5782024-09-06Warnings, Adverse reactionsName fallback
generic name: PREGABALIN
PregabalinPREGABALINBryant Ranch Prepackfac0eb4e-12ef-4e8e-8cbe-c43c26f0faee2024-08-23Warnings, Adverse reactionsName fallback
generic name: PREGABALIN
PregabalinPREGABALINAdvanced Rx Pharmacy of Tennessee, LLCf98c5df7-9b85-eacc-e053-6294a90a88ec2024-08-22Warnings, Adverse reactionsName fallback
generic name: PREGABALIN
PregabalinPREGABALINBryant Ranch Prepackc72b0bed-b7b4-4ae1-914e-756d76b66ed92024-08-20Warnings, Adverse reactionsName fallback
generic name: PREGABALIN
PregabalinPREGABALINBryant Ranch Prepackaac1f2f4-5ef5-49dd-b914-54f2cf2b1bc12024-08-12Warnings, Adverse reactionsName fallback
generic name: PREGABALIN
PregabalinPREGABALINBryant Ranch Prepackb2d45d41-a787-4912-962d-0bd98b70d58a2024-08-12Warnings, Adverse reactionsName fallback
generic name: PREGABALIN
PregabalinPREGABALINBryant Ranch Prepack616b37d6-93d5-44de-a993-bddf59eaee9a2024-08-12Warnings, Adverse reactionsName fallback
generic name: PREGABALIN
PregabalinPREGABALINAphena Pharma Solutions - Tennessee, LLC8bb9495e-1354-4a70-baa5-9b80eb3518c82024-07-28Warnings, Adverse reactionsName fallback
generic name: PREGABALIN
PregabalinPREGABALINAphena Pharma Solutions - Tennessee, LLCaa55a53c-96f6-4e0a-8b1d-e9d36e6ef2ec2024-07-28Warnings, Adverse reactionsName fallback
generic name: PREGABALIN
PregabalinPREGABALINBryant Ranch Prepack29a869b8-0d9f-4e3f-820a-061aa42ee4822024-07-16Warnings, Adverse reactionsName fallback
generic name: PREGABALIN
PregabalinPREGABALINBryant Ranch Prepackd70a5102-eb8d-45f1-acd0-692e9208428e2024-07-08Warnings, Adverse reactionsName fallback
generic name: PREGABALIN
PregabalinPREGABALINBryant Ranch Prepack59f94cd9-0fc9-4e55-8004-578971a1b42f2024-07-08Warnings, Adverse reactionsName fallback
generic name: PREGABALIN
PregabalinPREGABALINAmerican Health Packaging59da1a16-d409-49eb-9b44-397c770060432024-06-13Warnings, Adverse reactionsName fallback
generic name: PREGABALIN
PregabalinPREGABALINAdvanced Rx of Tennessee, LLC1a15cd11-0db9-2bc8-e063-6394a90a11fb2024-06-05Warnings, Adverse reactionsName fallback
generic name: PREGABALIN
PREGABALINPREGABALINBryant Ranch Prepack15b5e3d0-2bad-4363-99cb-e15819c41fda2024-05-20Warnings, Adverse reactionsName fallback
generic name: PREGABALIN
PregabalinPREGABALINAphena Pharma Solutions - Tennessee, LLC15ea709a-d502-41ea-e063-6394a90ad97d2024-04-12Warnings, Adverse reactionsName fallback
generic name: PREGABALIN
PregabalinPREGABALINAphena Pharma Solutions - Tennessee, LLC124d7552-e48d-b160-e063-6294a90a196f2024-02-26Warnings, Adverse reactionsName fallback
generic name: PREGABALIN
PregabalinPREGABALINAphena Pharma Solutions - Tennessee, LLC11fe25cd-1aca-0e63-e063-6394a90a197e2024-02-22Warnings, Adverse reactionsName fallback
generic name: PREGABALIN
PregabalinPREGABALINAphena Pharma Solutions - Tennessee, LLC4ed3e73c-13e7-4646-874d-276b6c75d2c92024-02-08Warnings, Adverse reactionsName fallback
generic name: PREGABALIN
PregabalinPREGABALINSun Pharmaceutical Industries, Inc.ee7b9119-e88f-48ad-ae97-55e53374e62f2023-12-21Warnings, 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