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 2 of 3 · 41 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ClarithromycinCLARITHROMYCINA-S Medication Solutions25debd85-0840-4f8d-9898-027772061dd22025-06-09Warnings, Adverse reactionsName fallback
generic name: CLARITHROMYCIN
clarithromycinCLARITHROMYCINActavis Pharma, Inc.d5be5f12-6392-4d7d-ab23-ebc205ac1a852025-05-30Warnings, Adverse reactionsName fallback
generic name: CLARITHROMYCIN
ClarithromycinCLARITHROMYCINCoupler LLC2d6cfd87-9b8c-bba9-e063-6294a90aff5a2025-02-05Warnings, Adverse reactionsName fallback
generic name: CLARITHROMYCIN
ClarithromycinCLARITHROMYCINNuCare Pharmaceuticals,Inc.9143b79c-4c79-43ac-e053-2995a90ad7082025-02-04Warnings, Adverse reactionsName fallback
generic name: CLARITHROMYCIN
ClarithromycinCLARITHROMYCINDirectRxd22bd12c-737b-4aab-e053-2995a90aff602025-01-20Warnings, Adverse reactionsName fallback
generic name: CLARITHROMYCIN
ClarithromycinCLARITHROMYCINBryant Ranch Prepack27e02b77-4332-49e0-8d0c-a072cf5dff922024-05-01Warnings, Adverse reactionsName fallback
generic name: CLARITHROMYCIN
ClarithromycinCLARITHROMYCINProficient Rx LP28f60574-4ecd-441c-aebe-5b1d18033ef62024-02-01Warnings, Adverse reactionsName fallback
generic name: CLARITHROMYCIN
ClarithromycinCLARITHROMYCINBryant Ranch Prepack0c7d8391-50ef-4827-abe6-e0fc0c2f16362024-01-16Warnings, Adverse reactionsName fallback
generic name: CLARITHROMYCIN
ClarithromycinCLARITHROMYCINRising Pharma Holdings, Inc.0c4db97f-f4c9-4cac-9f12-9db1d967ebeb2024-01-05Warnings, Adverse reactionsName fallback
generic name: CLARITHROMYCIN
ClarithromycinCLARITHROMYCINA-S Medication Solutionsadba78c2-9e51-4bed-8c6a-6f977f79c40c2023-12-14Warnings, Adverse reactionsName fallback
generic name: CLARITHROMYCIN
ClarithromycinCLARITHROMYCINLannett Company, Inc.9bf207c0-86eb-4f3b-92e7-f65f3fccd5a72023-11-13Warnings, Adverse reactionsName fallback
generic name: CLARITHROMYCIN
ClarithromycinCLARITHROMYCINAurobindo Pharma Limited9aaffb41-408c-4372-8fd5-1d649450c0e92023-10-10Warnings, Adverse reactionsName fallback
generic name: CLARITHROMYCIN
ClarithromycinCLARITHROMYCINLannett Company, Inc.71a836d0-d60f-6418-e053-2a95a90aa6ef2023-09-22Warnings, Adverse reactionsName fallback
generic name: CLARITHROMYCIN
ClarithromycinCLARITHROMYCINSandoz Inc22457862-0f88-4be8-b507-1c8f264269f22023-09-13Warnings, Adverse reactionsName fallback
generic name: CLARITHROMYCIN
ClarithromycinCLARITHROMYCINA-S Medication Solutions1d6f5a9d-51b2-4e0d-b573-ccf08fe6ea232023-07-31Warnings, Adverse reactionsName fallback
generic name: CLARITHROMYCIN
ClarithromycinCLARITHROMYCINSandoz Incb98b02bb-2609-49a0-b29f-e5911aa0cbc12023-05-30Warnings, Adverse reactionsName fallback
generic name: CLARITHROMYCIN
ClarithromycinCLARITHROMYCINAlembic Pharmaceuticals Limited268d21f9-02c9-41b0-9487-7968ea12720d2023-05-29Warnings, Adverse reactionsName fallback
generic name: CLARITHROMYCIN
ClarithromycinCLARITHROMYCINAlembic Pharmaceuticals Inc.cde51c9f-f7b8-413f-8b8e-e56370cd57542023-05-26Warnings, Adverse reactionsName fallback
generic name: CLARITHROMYCIN
CLARITHROMYCINCLARITHROMYCINChartwell RX, LLC.99d2fd6b-39ca-42f9-ad06-30e7fbc22c472022-12-23Warnings, Adverse reactionsName fallback
generic name: CLARITHROMYCIN
ClarithromycinCLARITHROMYCINProficient Rx LPb1bdf526-4f16-4130-b614-4cb678f060d72021-01-01Warnings, Adverse reactionsName fallback
generic name: CLARITHROMYCIN

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

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