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 5 of 6 · 107 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AzithromycinAZITHROMYCINA-S Medication Solutions4278e306-bc26-4282-93ce-f1405e0b5d4a2024-06-12Warnings, Adverse reactionsName fallback
brand name: Azithromycin
generic name: AZITHROMYCIN
AzithromycinAZITHROMYCINChartwell RX, LLC2c9de2e9-c20c-4660-a272-a22019f9fb022024-04-09Warnings, Adverse reactionsName fallback
brand name: Azithromycin
generic name: AZITHROMYCIN
AzithromycinAZITHROMYCINProficient Rx LP44134421-cb0b-4e85-a3c8-d58bdb476fad2024-04-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Azithromycin
generic name: AZITHROMYCIN
AzithromycinAZITHROMYCINSTATE HEALTH SERVICES, TEXAS DEPARTMENT OF2b821631-0df2-0fb2-e054-00144ff8d46c2024-02-29Warnings, Adverse reactionsName fallback
brand name: Azithromycin
generic name: AZITHROMYCIN
AzithromycinAZITHROMYCINAsclemed USA, Inc.b77b347d-d357-4bdf-b985-49d9a1dd634c2023-12-30Warnings, Adverse reactionsName fallback
brand name: Azithromycin
generic name: AZITHROMYCIN
AzithromycinAZITHROMYCINBionpharma Inc.a2754618-3df1-4b89-aa09-fdff4b71b7e42023-12-24Warnings, Adverse reactionsName fallback
brand name: Azithromycin
generic name: AZITHROMYCIN
AzithromycinAZITHROMYCINA-S Medication Solutions5ed68b5a-4093-49f1-871b-7b0da5f7be2d2023-10-31Warnings, Adverse reactionsName fallback
brand name: Azithromycin
generic name: AZITHROMYCIN
AzithromycinAZITHROMYCINAsclemed USA, Inc.9c44af6d-8a9a-cb4c-e053-2a95a90afdac2023-09-01Warnings, Adverse reactionsName fallback
brand name: Azithromycin
generic name: AZITHROMYCIN
AzithromycinAZITHROMYCINA-S Medication Solutionsaf720986-48a9-48b5-bdd7-370f6a2f92e12023-04-24Warnings, Adverse reactionsName fallback
brand name: Azithromycin
generic name: AZITHROMYCIN
AzithromycinAZITHROMYCINTeva Pharmaceuticals USA, Inc.f6a52c0b-45db-422e-8c22-e867a11b44392023-03-01Warnings, Adverse reactionsName fallback
brand name: Azithromycin
generic name: AZITHROMYCIN
AzithromycinAZITHROMYCINA-S Medication Solutions22a2bdcb-3012-42fb-ac66-d1d8791009402023-02-06Warnings, Adverse reactionsName fallback
brand name: Azithromycin
generic name: AZITHROMYCIN
AZITHROMYCINAZITHROMYCINAlembic Pharmaceuticals Limited5dca5a11-3c02-4a51-a35d-f91f37b8e00c2023-01-27Warnings, Adverse reactionsName fallback
brand name: AZITHROMYCIN
generic name: AZITHROMYCIN
AzithromycinAZITHROMYCINAlembic Pharmaceuticals Limitedd5c95c30-564f-4b67-ac6d-9179cdfaa5a82023-01-13Warnings, Adverse reactionsName fallback
brand name: Azithromycin
generic name: AZITHROMYCIN
AzithromycinAZITHROMYCINAlembic Pharmaceuticals Limiteddeea1a56-84ed-4ce4-9d11-03271510c0a12023-01-12Warnings, Adverse reactionsName fallback
brand name: Azithromycin
generic name: AZITHROMYCIN
AzithromycinAZITHROMYCIN DIHYDRATESlate Run Pharmaceuticals8acce3c1-f4be-4968-a71f-3ffd9fbaa4a42022-12-01Warnings, Adverse reactionsName fallback
brand name: Azithromycin
AZITHROMYCINAZITHROMYCINProficient Rx LPe1172805-0930-4fb9-8a2f-e0d6a04306302022-11-01Warnings, Adverse reactionsName fallback
brand name: AZITHROMYCIN
generic name: AZITHROMYCIN
AzithromycinAZITHROMYCINProficient Rx LP34e6364a-ac3d-434e-a90c-cb13ebcf79832022-11-01Warnings, Adverse reactionsName fallback
brand name: Azithromycin
generic name: AZITHROMYCIN
AzithromycinAZITHROMYCINProficient Rx LP33140df5-420d-469f-b6c8-121e952a5cb62022-11-01Warnings, Adverse reactionsName fallback
brand name: Azithromycin
generic name: AZITHROMYCIN
AZITHROMYCINAZITHROMYCINProficient Rx LPb3761d39-9b79-4908-8b05-a1c91e5999982022-11-01Warnings, Adverse reactionsName fallback
brand name: AZITHROMYCIN
generic name: AZITHROMYCIN
AzithromycinAZITHROMYCIN MONOHYDRATEPharmPak, Inc.ba57ff26-cd02-4f57-ac92-b613d245a4ea2022-10-14Warnings, Adverse reactionsName fallback
brand 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