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 1 of 6 · 107 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AzithromycinAZITHROMYCINNuCare Pharmaceuticals,Inc.94e17ae5-0871-67a0-e053-2995a90ae0ae2026-09-09Warnings, Adverse reactionsName fallback
brand name: Azithromycin
generic name: AZITHROMYCIN
azithromycinAZITHROMYCINREMEDYREPACK INC.da399401-1ee6-422a-be46-0bba6b264b2f2026-09-08Warnings, Adverse reactionsName fallback
brand name: azithromycin
generic name: AZITHROMYCIN
AzithromycinAZITHROMYCINAurobindo Pharma Limited3c902990-b870-4725-b9fe-76b8be633e1c2026-09-03Warnings, Adverse reactionsName fallback
brand name: Azithromycin
generic name: AZITHROMYCIN
azithromycinAZITHROMYCINMajor Pharmaceuticals814abe38-da4a-48af-bf4b-2ce04a5aabd12026-09-02Warnings, Adverse reactionsName fallback
brand name: azithromycin
generic name: AZITHROMYCIN
azithromycinAZITHROMYCINREMEDYREPACK INC.bf061799-cdef-40f8-b1ce-bc5eb609f8c32026-09-02Warnings, Adverse reactionsName fallback
brand name: azithromycin
generic name: AZITHROMYCIN
AzithromycinAZITHROMYCINAurobindo Pharma Limited795c13cd-e9ca-481b-9fa9-2890bdf9dac82026-09-02Warnings, Adverse reactionsName fallback
brand name: Azithromycin
generic name: AZITHROMYCIN
azithromycinAZITHROMYCINLupin Pharmaceuticals, Inc.01649d79-4677-4577-a3e4-e054f3f9fc3b2026-08-20Warnings, Adverse reactionsName fallback
brand name: azithromycin
generic name: AZITHROMYCIN
azithromycinAZITHROMYCINLupin Pharmaceuticals, Inc.c9990a1d-5238-403e-9221-72a9314d7b5e2026-08-20Warnings, Adverse reactionsName fallback
brand name: azithromycin
generic name: AZITHROMYCIN
AzithromycinAZITHROMYCINZydus Pharmaceuticals USA Inc.99e5bd22-a721-4e2e-a46c-d61a53c25c3d2026-08-14Warnings, Adverse reactionsName fallback
brand name: Azithromycin
generic name: AZITHROMYCIN
AzithromycinAZITHROMYCINREMEDYREPACK INC.614cc2a4-3fc7-455d-9e8a-212c496f0fbf2026-08-05Warnings, Adverse reactionsName fallback
brand name: Azithromycin
generic name: AZITHROMYCIN
AzithromycinAZITHROMYCINSandoz Inc34b70c23-92a6-460f-8dbb-15a0e6b9d3a92026-07-30Warnings, Adverse reactionsName fallback
brand name: Azithromycin
generic name: AZITHROMYCIN
AzithromycinAZITHROMYCINNuCare Pharmaceuticals,Inc.a9cdb5ae-2aeb-c598-e053-2a95a90a80622026-07-30Warnings, Adverse reactionsName fallback
brand name: Azithromycin
generic name: AZITHROMYCIN
AzithromycinAZITHROMYCINSandoz Incec619299-e0ef-44dd-acdb-8c53bbfc5b8a2026-07-30Warnings, Adverse reactionsName fallback
brand name: Azithromycin
generic name: AZITHROMYCIN
AzithromycinAZITHROMYCINA-S Medication Solutions882f71b1-b153-4856-b4a7-1a29ae9cf2472026-07-29Warnings, Adverse reactionsName fallback
brand name: Azithromycin
generic name: AZITHROMYCIN
AzithromycinAZITHROMYCINEugia US LLC7b81436e-d14a-4353-a22d-253f45e2e5762026-07-27Warnings, Adverse reactionsName fallback
brand name: Azithromycin
generic name: AZITHROMYCIN
AzithromycinAZITHROMYCINA-S Medication Solutions3b7e16b1-9a3c-4e3a-8411-841a708afe452026-07-23Warnings, Adverse reactionsName fallback
brand name: Azithromycin
generic name: AZITHROMYCIN
AzithromycinAZITHROMYCINA-S Medication Solutions58308e8b-57bd-4e82-a2e8-24aac63194cd2026-07-23Warnings, Adverse reactionsName fallback
brand name: Azithromycin
generic name: AZITHROMYCIN
AzithromycinAZITHROMYCINBryant Ranch Prepack2a8010dc-700f-45d3-94ca-ebe4a51acc1b2026-07-20Warnings, Adverse reactionsName fallback
brand name: Azithromycin
generic name: AZITHROMYCIN
AzithromycinAZITHROMYCINBryant Ranch Prepack6caeda98-7020-413a-9461-04f476dad4ba2026-07-20Warnings, Adverse reactionsName fallback
brand name: Azithromycin
generic name: AZITHROMYCIN
AzithromycinAZITHROMYCINA-S Medication Solutions3c4861f2-825e-4e3b-9907-9658a849079e2026-07-16Warnings, 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