FDA.reportPublic FDA data

Application 202308

Type
ANDA
Sponsor
SANDOZ INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AZITHROMYCINAZITHROMYCINSOLUTION; OPHTHALMIC1%NoNo

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 6 · 107 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AzithromycinAZITHROMYCINREMEDYREPACK INC.333ffe63-aaeb-4dff-b595-1c11209189a62026-07-01Warnings, Adverse reactionsName fallback
brand name: Azithromycin
generic name: AZITHROMYCIN
AZITHROMYCINAZITHROMYCINA-S Medication Solutions76093152-e2d7-4fe1-8568-1f0fec1747c22026-07-01Warnings, Adverse reactionsName fallback
brand name: AZITHROMYCIN
generic name: AZITHROMYCIN
AzithromycinAZITHROMYCINREMEDYREPACK INC.943b9246-7733-44b1-875c-91d2ade78ac42026-06-29Warnings, Adverse reactionsName fallback
brand name: Azithromycin
generic name: AZITHROMYCIN
AzithromycinAZITHROMYCINPreferred Pharmaceuticals Inc.661ff7a6-6394-493d-a307-a1f607e5d1172026-06-16Warnings, Adverse reactionsName fallback
brand name: Azithromycin
generic name: AZITHROMYCIN
AzithromycinAZITHROMYCINBryant Ranch Prepackb5d79719-b1dc-469f-a19c-f8ba615138f02026-05-14Warnings, Adverse reactionsName fallback
brand name: Azithromycin
generic name: AZITHROMYCIN
azithromycinAZITHROMYCINCoupler LLC510024c9-6658-e08f-e063-6294a90a07932026-05-04Warnings, Adverse reactionsName fallback
brand name: azithromycin
generic name: AZITHROMYCIN
AzithromycinAZITHROMYCINSportpharm LLC397471e5-76e2-462c-af30-bcc54fe002662026-04-24Warnings, Adverse reactionsName fallback
brand name: Azithromycin
generic name: AZITHROMYCIN
azithromycinAZITHROMYCINCardinal Health 107, LLCea128124-8712-4998-be46-47d43ef127d42026-04-10Warnings, Adverse reactionsName fallback
brand name: azithromycin
generic name: AZITHROMYCIN
AzithromycinAZITHROMYCINBryant Ranch Prepacka81212ef-76b6-4bd7-8706-3d2b05ee34f92026-03-30Warnings, Adverse reactionsName fallback
brand name: Azithromycin
generic name: AZITHROMYCIN
AzithromycinAZITHROMYCINA-S Medication Solutions24c07398-84ad-48e2-9625-e9073c28fb732026-03-24Warnings, Adverse reactionsName fallback
brand name: Azithromycin
generic name: AZITHROMYCIN
AzithromycinAZITHROMYCINA-S Medication Solutions77c5e4c6-6d16-40fe-bf36-cb441348f39b2026-03-24Warnings, Adverse reactionsName fallback
brand name: Azithromycin
generic name: AZITHROMYCIN
AzithromycinAZITHROMYCINAvKAREdc633b7d-5154-7e43-e053-2a95a90ad2a62026-03-17Warnings, Adverse reactionsName fallback
brand name: Azithromycin
generic name: AZITHROMYCIN
AZITHROMYCINAZITHROMYCINDIRECT RXa5b4092d-ab72-f5d1-e053-2995a90ac5822026-03-17Warnings, Adverse reactionsName fallback
brand name: AZITHROMYCIN
generic name: AZITHROMYCIN
AzithromycinAZITHROMYCINPreferred Pharmaceuticals Inc.003307c5-3f73-4a5d-a704-bfdea3c656e82026-03-16Warnings, Adverse reactionsName fallback
brand name: Azithromycin
generic name: AZITHROMYCIN
AzithromycinAZITHROMYCINPreferred Pharmaceuticals Inc.4eec460d-5ba8-4614-8700-219a9b4fc3852026-03-16Warnings, Adverse reactionsName fallback
brand name: Azithromycin
generic name: AZITHROMYCIN
AZITHROMYCINAZITHROMYCINPreferred Pharmaceuticals, Inc.9e4fbd52-43e4-4d87-a136-f4d680a8d0c12026-03-12Warnings, Adverse reactionsName fallback
brand name: AZITHROMYCIN
generic name: AZITHROMYCIN
AzithromycinAZITHROMYCINPreferred Pharmaceuticals Inc.ac327054-21ab-401c-a27a-48259db18f892026-03-11Warnings, Adverse reactionsName fallback
brand name: Azithromycin
generic name: AZITHROMYCIN
AzithromycinAZITHROMYCINPreferred Pharmaceuticals Inc.a1c96531-bbd2-4dc5-8eeb-3f0276cd09562026-03-11Warnings, Adverse reactionsName fallback
brand name: Azithromycin
generic name: AZITHROMYCIN
azithromycinAZITHROMYCINRising Pharma Holdings, Inc.5199689f-8881-7757-e063-6394a90ae2eb2026-02-26Warnings, Adverse reactionsName fallback
brand name: azithromycin
generic name: AZITHROMYCIN
AZITHROMYCINAZITHROMYCINA-S Medication Solutions405ab07f-7d1d-4552-ad3b-2a03be8e99492026-02-17Warnings, Adverse reactionsName fallback
brand name: AZITHROMYCIN
generic name: AZITHROMYCIN

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
10019ORIG2014-02-26