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 4 of 6 · 107 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AZITHROMYCINAZITHROMYCINDirectRxd564d91e-3039-c120-e053-2995a90ae6db2025-01-21Warnings, Adverse reactionsName fallback
brand name: AZITHROMYCIN
generic name: AZITHROMYCIN
AzithromycinAZITHROMYCINZydus Lifesciences Limited0b63649d-558c-4250-90ee-af6e1e5c6d2c2025-01-09Name fallback
brand name: Azithromycin
generic name: AZITHROMYCIN
AzithromycinAZITHROMYCINAdvanced Rx Pharmacy of Tennessee, LLCf175496a-4ad3-ce0d-e053-2a95a90a66132024-12-31Warnings, Adverse reactionsName fallback
brand name: Azithromycin
generic name: AZITHROMYCIN
AzithromycinAZITHROMYCIN MONOHYDRATEFresenius Kabi USA, LLCb69917c0-95d5-4b29-b0e3-07054a4fd79f2024-10-11Warnings, Adverse reactionsName fallback
brand name: Azithromycin
AzithromycinAZITHROMYCIN MONOHYDRATEFresenius Kabi USA, LLC9ad099d5-5c57-4855-98a4-e03fb4629dbf2024-10-11Warnings, Adverse reactionsName fallback
brand name: Azithromycin
AzithromycinAZITHROMYCINAsclemed USA, Inc.22a4d2b3-daea-4d96-891f-4b98236294562024-10-04Warnings, Adverse reactionsName fallback
brand name: Azithromycin
generic name: AZITHROMYCIN
AzithromycinAZITHROMYCINProficient Rx LP90605f94-93e1-43d1-8be7-830e816ac84f2024-10-01Warnings, Adverse reactionsName fallback
brand name: Azithromycin
generic name: AZITHROMYCIN
AzithromycinAZITHROMYCINProficient Rx LP38942011-f86b-4e42-a4ca-05a70d9dd3d92024-10-01Warnings, Adverse reactionsName fallback
brand name: Azithromycin
generic name: AZITHROMYCIN
AzithromycinAZITHROMYCIN MONOHYDRATESagent Pharmaceuticals6497fb5e-82d8-4411-b994-7ee01333ffd72024-09-19Warnings, Adverse reactionsName fallback
brand name: Azithromycin
AzithromycinAZITHROMYCINA-S Medication Solutionsf97d2e7e-ccfd-4f04-85ba-549b37f6aa7b2024-07-22Warnings, Adverse reactionsName fallback
brand name: Azithromycin
generic name: AZITHROMYCIN
AzithromycinAZITHROMYCINNuCare Pharmaceuticals,Inc.b0138503-ddc4-2e1c-e053-2995a90a0d2d2024-07-17Warnings, Adverse reactionsName fallback
brand name: Azithromycin
generic name: AZITHROMYCIN
AzithromycinAZITHROMYCINNuCare Pharmaceuticals,Inc.b43d23c7-1a2e-ce93-e053-2995a90a65a42024-07-17Warnings, Adverse reactionsName fallback
brand name: Azithromycin
generic name: AZITHROMYCIN
AzithromycinAZITHROMYCINNuCare Pharmaceuticals,Inc.549cdd0a-da79-23b8-e054-00144ff8d46c2024-07-17Warnings, Adverse reactionsName fallback
brand name: Azithromycin
generic name: AZITHROMYCIN
AZITHROMYCINAZITHROMYCINNuCare Pharmaceuticals,Inc.90a506cd-aae7-a622-e053-2a95a90ad3522024-06-19Warnings, Adverse reactionsName fallback
brand name: AZITHROMYCIN
generic name: AZITHROMYCIN
AzithromycinAZITHROMYCINNuCare Pharmaceuticals,Inc.9270e676-3382-6483-e053-2a95a90a556e2024-06-19Warnings, Adverse reactionsName fallback
brand name: Azithromycin
generic name: AZITHROMYCIN
AzithromycinAZITHROMYCINNuCare Pharmaceuticals,Inc.8e7184e1-3c3c-cd87-e053-2a95a90a6eb62024-06-18Warnings, Adverse reactionsName fallback
brand name: Azithromycin
generic name: AZITHROMYCIN
AZITHROMYCINAZITHROMYCINNuCare Pharmaceuticals,Inc.82454fb2-e524-ecb8-e053-2991aa0a6e7c2024-06-14Warnings, Adverse reactionsName fallback
brand name: AZITHROMYCIN
generic name: AZITHROMYCIN
AzithromycinAZITHROMYCINNuCare Pharmaceuticals,Inc.826f9c07-8eb9-a128-e053-2991aa0ad6542024-06-14Warnings, Adverse reactionsName fallback
brand name: Azithromycin
generic name: AZITHROMYCIN
AZITHROMYCINAZITHROMYCINNuCare Pharmaceuticals,Inc.8389c336-25eb-a96f-e053-2a91aa0a0dd82024-06-14Warnings, Adverse reactionsName fallback
brand name: AZITHROMYCIN
generic name: AZITHROMYCIN
AzithromycinAZITHROMYCINNuCare Pharmaceuticals,Inc.896cce83-23ac-f4ed-e053-2a95a90ad1072024-06-14Warnings, 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