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 8 of 12 · 226 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
pregabalinPREGABALINDr.Reddys Laboratories Incceed457b-8f43-4021-fd70-071c96e094702025-05-20Warnings, Adverse reactionsName fallback
generic name: PREGABALIN
PregabalinPREGABALINCipla USA, Inc.17a8087c-579f-42de-ae92-006ea64def2a2025-05-01Warnings, Adverse reactionsName fallback
generic name: PREGABALIN
PregabalinPREGABALINExelan Pharmaceuticals Inc.3fdc6e94-2504-416c-81dd-2db9bc194ebb2025-05-01Warnings, Adverse reactionsName fallback
generic name: PREGABALIN
LyricaPREGABALINViatris Specialty LLCd4734e7d-5079-455e-8ff5-8f4539c998a92025-04-15Warnings, Adverse reactionsName fallback
brand name: Lyrica
generic name: PREGABALIN
PregabalinPREGABALINMylan Pharmaceuticals Inc.ebe34db4-816d-4f0a-adbb-8266936627542025-04-12Warnings, Adverse reactionsName fallback
generic name: PREGABALIN
PregabalinPREGABALINAphena Pharma Solutions - Tennessee, LLCb1f4b888-ac88-4250-8db1-706e7cc01e932025-03-21Warnings, Adverse reactionsName fallback
generic name: PREGABALIN
PregabalinPREGABALINAphena Pharma Solutions - Tennessee, LLCb0f34220-0657-4868-ae01-014f9300f6222025-03-03Warnings, Adverse reactionsName fallback
generic name: PREGABALIN
PregabalinPREGABALINProficient Rx LP580955ba-86f6-4e86-b0fa-dd44e8828b0e2025-03-01Warnings, Adverse reactionsName fallback
generic name: PREGABALIN
PregabalinPREGABALINProficient Rx LPa025e4fc-e0c1-4c5b-a1c8-bd8e578a737e2025-03-01Warnings, Adverse reactionsName fallback
generic name: PREGABALIN
PregabalinPREGABALINCoupler LLC2ccc641e-6859-046e-e063-6294a90a50172025-01-28Warnings, Adverse reactionsName fallback
generic name: PREGABALIN
PREGABALINPREGABALINDirect_Rx8efb9652-86b9-4cb5-e053-2995a90adac02025-01-22Warnings, Adverse reactionsName fallback
generic name: PREGABALIN
PREGABALINPREGABALINDirect_Rx8ee9e08f-cf87-599c-e053-2995a90a563c2025-01-22Warnings, Adverse reactionsName fallback
generic name: PREGABALIN
PREGABALINPREGABALINDirect Rxd88925b8-9be6-d862-e053-2995a90a16122025-01-21Adverse reactionsName fallback
generic name: PREGABALIN
PREGABALINPREGABALINDirect_Rx91cf12b1-e1a6-dbc2-e053-2a95a90a8d5d2025-01-17Warnings, Adverse reactionsName fallback
generic name: PREGABALIN
PregabalinPREGABALINPreferred Pharmaceuticals, Inc.8c3aedae-9745-4f63-ad64-a643f02454182025-01-16Warnings, Adverse reactionsName fallback
generic name: PREGABALIN
PregabalinPREGABALINProficient Rx LP2b87989d-6411-4996-8f05-05806ab805252025-01-01Warnings, Adverse reactionsName fallback
generic name: PREGABALIN
PregabalinPREGABALINAdvanced Rx of Tennessee, LLCafc89ca3-5597-1c75-e053-2a95a90a3ff22024-12-31Warnings, Adverse reactionsName fallback
generic name: PREGABALIN
PregabalinPREGABALINAdvanced Rx of Tennessee, LLCafd59273-75d1-5f33-e053-2995a90ab25f2024-12-31Warnings, Adverse reactionsName fallback
generic name: PREGABALIN
PregabalinPREGABALINAdvanced Rx of Tennessee, LLCafc8d9f1-df31-607b-e053-2995a90a028c2024-12-31Warnings, Adverse reactionsName fallback
generic name: PREGABALIN
PregabalinPREGABALINAdvanced Rx of Tennessee, LLCafc8c76e-9b21-7ddb-e053-2a95a90ad7362024-12-31Warnings, 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