FDA.reportPublic FDA data

Application 050697

Type
NDA
Sponsor
ABBVIE INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BIAXIN XLCLARITHROMYCINTABLET;ORAL250MGNoNo
002BIAXIN XLCLARITHROMYCINTABLET;ORAL500MGNoNo

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 1 of 3 · 42 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ClarithromycinCLARITHROMYCINSportpharm LLCd836ae7e-fdbf-4dcb-a90d-ede1dcbc3e672026-06-24Warnings, Adverse reactionsName fallback
generic name: CLARITHROMYCIN
ClarithromycinCLARITHROMYCINREMEDYREPACK INC.9d5848f0-e9f0-4112-a7ca-bcc8ea2e69c62026-06-24Warnings, Adverse reactionsName fallback
generic name: CLARITHROMYCIN
ClarithromycinCLARITHROMYCINSportpharm LLCde33ba3a-9df1-4076-8d5f-b603d26980962026-04-17Warnings, Adverse reactionsName fallback
generic name: CLARITHROMYCIN
ClarithromycinCLARITHROMYCINSolaris Pharma Corporation4d42821d-ce7a-7d64-e063-6294a90a08752026-04-09Warnings, Adverse reactionsName fallback
generic name: CLARITHROMYCIN
ClarithromycinCLARITHROMYCINProficient Rx LP88c7ded8-333c-408d-b693-a72881710f592026-04-01Warnings, Adverse reactionsName fallback
generic name: CLARITHROMYCIN
ClarithromycinCLARITHROMYCINPreferred Pharmaceuticals Inc.81c0c69e-b1ae-42f3-9e85-09b8daa75d8d2026-03-30Warnings, Adverse reactionsName fallback
generic name: CLARITHROMYCIN
ClarithromycinCLARITHROMYCINMajor Pharmaceuticalsd0a66646-6774-4fc6-9b26-a98c3a5df2742026-03-26Warnings, Adverse reactionsName fallback
generic name: CLARITHROMYCIN
ClarithromycinCLARITHROMYCINAmerican Health Packaging59ebe6cb-c830-45c7-8242-52f9f42a90a02026-03-19Warnings, Adverse reactionsName fallback
generic name: CLARITHROMYCIN
ClarithromycinCLARITHROMYCINSolaris Pharma Corporation4d4303f8-88dd-8b88-e063-6394a90ab48f2026-03-17Warnings, Adverse reactionsName fallback
generic name: CLARITHROMYCIN
ClarithromycinCLARITHROMYCINAmerican Health Packagingfa69ea92-0b41-43fb-918f-ed80e0dedf042026-03-04Warnings, Adverse reactionsName fallback
generic name: CLARITHROMYCIN
ClarithromycinCLARITHROMYCINA-S Medication Solutionsfad1e5a3-59f9-4868-9937-d3b061ab8f002026-02-19Warnings, Adverse reactionsName fallback
generic name: CLARITHROMYCIN
ClarithromycinCLARITHROMYCINAvPAK1920f943-bbf1-cfd9-7475-96a35680a9e02026-02-11Warnings, Adverse reactionsName fallback
generic name: CLARITHROMYCIN
ClarithromycinCLARITHROMYCINNorthwind Health Company, LLC471f638a-9dd1-09d3-e063-6294a90a2d4f2026-01-08Warnings, Adverse reactionsName fallback
generic name: CLARITHROMYCIN
ClarithromycinCLARITHROMYCINNorthwind Health Company, LLCf98aacb4-2f01-3e94-e053-6294a90a9aa02026-01-01Warnings, Adverse reactionsName fallback
generic name: CLARITHROMYCIN
CLARITHROMYCINCLARITHROMYCINChartwell RX, LLCdea5bd78-7f93-4bc4-a2e4-1b021f5fe0982025-12-10Warnings, Adverse reactionsName fallback
generic name: CLARITHROMYCIN
ClarithromycinCLARITHROMYCINProficient Rx LP9eb306e0-ccfb-418c-82ca-204f20a788f72025-11-01Warnings, Adverse reactionsName fallback
generic name: CLARITHROMYCIN
ClarithromycinCLARITHROMYCINPD-Rx Pharmaceuticals, Inc.1d328f5d-73c1-4df7-a3df-71d0e02211812025-10-17Warnings, Adverse reactionsName fallback
generic name: CLARITHROMYCIN
ClarithromycinCLARITHROMYCINPD-Rx Pharmaceuticals, Inc.1cb8a78a-0f07-49e8-a23e-a776280062092025-10-16Warnings, Adverse reactionsName fallback
generic name: CLARITHROMYCIN
ClarithromycinCLARITHROMYCINPD-Rx Pharmaceuticals, Inc.0be243c6-de02-45dd-8210-cab1bbc8dfa72025-10-15Warnings, Adverse reactionsName fallback
generic name: CLARITHROMYCIN
ClarithromycinCLARITHROMYCINDirect_Rx3ba1da51-ba5b-323f-e063-6294a90a03332025-09-08Warnings, Adverse reactionsName fallback
generic name: CLARITHROMYCIN

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
8022SUPPL2004-07-21