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 9 of 12 · 226 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PregabalinPREGABALINAdvanced Rx of Tennessee, LLCaf739a0d-a3cd-754f-e053-2a95a90ad6552024-12-31Warnings, Adverse reactionsName fallback
generic name: PREGABALIN
PregabalinPREGABALINAdvanced Rx Pharmacy of Tennessee, LLCd28168cd-9b7a-f8df-e053-2995a90ad97f2024-12-31Warnings, Adverse reactionsName fallback
generic name: PREGABALIN
PregabalinPREGABALINAdvanced Rx Pharmacy of Tennessee, LLCb8172d6b-a646-e559-e053-2a95a90ac24d2024-12-31Warnings, Adverse reactionsName fallback
generic name: PREGABALIN
PregabalinPREGABALINAdvanced Rx Pharmacy of Tennessee, LLCbc1b143d-feaf-9498-e053-2995a90acf502024-12-31Warnings, Adverse reactionsName fallback
generic name: PREGABALIN
PregabalinPREGABALINAdvanced Rx Pharmacy of Tennessee, LLCb817083c-b535-2269-e053-2a95a90af5b92024-12-31Warnings, Adverse reactionsName fallback
generic name: PREGABALIN
PregabalinPREGABALINAdvanced Rx Pharmacy of Tennessee, LLCc6b456ca-9d07-7789-e053-2a95a90a20c52024-12-31Warnings, Adverse reactionsName fallback
generic name: PREGABALIN
PregabalinPREGABALINAdvanced Rx Pharmacy of Tennessee, LLCc8bfc4f9-6208-4eaa-e053-2a95a90ada972024-12-31Warnings, Adverse reactionsName fallback
generic name: PREGABALIN
PregabalinPREGABALINAdvanced Rx Pharmacy of Tennessee, LLCc8acdbcf-3076-63b2-e053-2a95a90aa3c42024-12-31Warnings, Adverse reactionsName fallback
generic name: PREGABALIN
PregabalinPREGABALINAdvanced Rx Pharmacy of Tennessee, LLCc89a3514-f637-e54f-e053-2a95a90a68812024-12-31Warnings, Adverse reactionsName fallback
generic name: PREGABALIN
PregabalinPREGABALINAdvanced Rx Pharmacy of Tennessee, LLCd2804923-a466-6dc6-e053-2a95a90a41822024-12-31Warnings, Adverse reactionsName fallback
generic name: PREGABALIN
PregabalinPREGABALINAdvanced Rx Pharmacy of Tennessee, LLCf5d9b625-783c-bd78-e053-2995a90a37d22024-12-31Warnings, Adverse reactionsName fallback
generic name: PREGABALIN
PregabalinPREGABALINAdvanced Rx Pharmacy of Tennessee, LLCf8ae62be-3a68-be6b-e053-6394a90ab6272024-12-31Warnings, Adverse reactionsName fallback
generic name: PREGABALIN
PregabalinPREGABALINAphena Pharma Solutions - Tennessee, LLC29b91992-c853-a57d-e063-6394a90ab3652024-12-20Warnings, Adverse reactionsName fallback
generic name: PREGABALIN
PregabalinPREGABALINQuality Care Products, LLC59432752-c8d8-4396-95dd-0e04c55bc82b2024-12-19Warnings, Adverse reactionsName fallback
generic name: PREGABALIN
PregabalinPREGABALINQuality Care Products, LLC1e087436-0534-4de2-b310-a5cc0e46adbd2024-12-18Warnings, Adverse reactionsName fallback
generic name: PREGABALIN
PREGABALINPREGABALINQuality Care Products, LLCff386af0-17d3-4f95-803b-b51cb79e52952024-12-18Warnings, Adverse reactionsName fallback
generic name: PREGABALIN
PREGABALINPREGABALINAdvanced Rx Pharmacy of Tennessee, LLCd2813712-d7f6-6144-e053-2995a90a3c5d2024-11-20Warnings, Adverse reactionsName fallback
generic name: PREGABALIN
PregabalinPREGABALINBryant Ranch Prepack4cda70e8-9ae1-4958-8c86-1bc633be982b2024-09-06Warnings, Adverse reactionsName fallback
generic name: PREGABALIN
PregabalinPREGABALINBryant Ranch Prepackcf7f0fd0-bac2-4836-9363-79d32ad0cc102024-09-06Warnings, Adverse reactionsName fallback
generic name: PREGABALIN
PregabalinPREGABALINBryant Ranch Prepack08ad87e3-e00c-46d1-98f8-df493cf1712e2024-09-06Warnings, 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