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 3 of 6 · 107 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AZITHROMYCINAZITHROMYCINEpic Pharma, LLC59c4b783-4ff7-4269-969b-58a10e12b12b2026-02-04Warnings, Adverse reactionsName fallback
brand name: AZITHROMYCIN
generic name: AZITHROMYCIN
AzithromycinAZITHROMYCINSportpharm LLC5f9e13f5-69ee-4220-90d9-31fa8660d8802026-02-03Warnings, Adverse reactionsName fallback
brand name: Azithromycin
generic name: AZITHROMYCIN
AzithromycinAZITHROMYCINSportpharm LLC60ec2020-148b-4a2a-96f2-dd09c590ecbb2026-02-03Warnings, Adverse reactionsName fallback
brand name: Azithromycin
generic name: AZITHROMYCIN
AzithromycinAZITHROMYCINAvKARE16da30a2-d11c-7e8c-e063-6294a90a62e32026-01-13Warnings, Adverse reactionsName fallback
brand name: Azithromycin
generic name: AZITHROMYCIN
AzithromycinAZITHROMYCINAiPing Pharmaceutical, Inc.d6fb42ed-7dac-4a7b-9964-d367dd47dd5c2026-01-10Warnings, Adverse reactionsName fallback
brand name: Azithromycin
generic name: AZITHROMYCIN
AzithromycinAZITHROMYCINRedpharm Drug2fd25741-f014-3999-e063-6394a90acdd02025-12-27Warnings, Adverse reactionsName fallback
brand name: Azithromycin
generic name: AZITHROMYCIN
AzithromycinAZITHROMYCINRedpharm Drug3745a0b0-7855-69eb-e063-6294a90ab6a82025-12-24Warnings, Adverse reactionsName fallback
brand name: Azithromycin
generic name: AZITHROMYCIN
AzithromycinAZITHROMYCINBionpharma Inc.859bb02c-a4bc-46fa-9fc9-def1219b5dfb2025-12-04Warnings, Adverse reactionsName fallback
brand name: Azithromycin
generic name: AZITHROMYCIN
AZITHROMYCINAZITHROMYCINPURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS714f6f55-278a-4fcf-8d4e-2ad9b43623a32025-11-20Warnings, Adverse reactionsName fallback
brand name: AZITHROMYCIN
generic name: AZITHROMYCIN
AZITHROMYCINAZITHROMYCINNuCare Pharmaceuticals, Inc.3f7c7421-411d-c04e-e063-6394a90a4aa02025-09-23Warnings, Adverse reactionsName fallback
brand name: AZITHROMYCIN
generic name: AZITHROMYCIN
AzithromycinAZITHROMYCINZhejiang Poly Pharm. Co., Ltd.33d0a4eb-5076-65c6-e063-6394a90ac13a2025-08-22Warnings, Adverse reactionsName fallback
brand name: Azithromycin
generic name: AZITHROMYCIN
AzithromycinAZITHROMYCIN MONOHYDRATESagent Pharmaceuticalscefbce3f-3e6c-4659-abd7-3ec3e82277372025-07-28Warnings, Adverse reactionsName fallback
brand name: Azithromycin
AzithromycinAZITHROMYCINAlembic Pharmaceuticals Inc.4314da8a-40e5-4aba-a32b-57b4166ade302025-06-30Warnings, Adverse reactionsName fallback
brand name: Azithromycin
generic name: AZITHROMYCIN
AzithromycinAZITHROMYCINAmerican Health Packaging6169e56c-10fb-448d-ab0f-14e54fcf28172025-06-12Warnings, Adverse reactionsName fallback
brand name: Azithromycin
generic name: AZITHROMYCIN
azithromycinAZITHROMYCINLannett Company, Inc.a2b0c06b-e93d-f5aa-e053-2995a90ac9aa2025-05-13Warnings, Adverse reactionsName fallback
brand name: azithromycin
generic name: AZITHROMYCIN
AzithromycinAZITHROMYCINA-S Medication Solutions47a8fd64-5a3d-490e-8ca8-5e6721c830cf2025-05-01Warnings, Adverse reactionsName fallback
brand name: Azithromycin
generic name: AZITHROMYCIN
azithromycinAZITHROMYCINProficient Rx LP25bc2e78-9d0d-41c6-a55e-a267d44579672025-04-01Warnings, Adverse reactionsName fallback
brand name: azithromycin
generic name: AZITHROMYCIN
AzithromycinAZITHROMYCIN MONOHYDRATEAthenex Pharmaceutical Division, LLC.610a34ea-6aa7-4b94-a85a-ff16ca537d032025-01-28Warnings, Adverse reactionsName fallback
brand name: Azithromycin
AzithromycinAZITHROMYCIN MONOHYDRATEAthenex Pharmaceutical Division, LLC.324330c5-20fe-4b22-adf2-14a6e91e71ef2025-01-28Warnings, Adverse reactionsName fallback
brand name: Azithromycin
AZITHROMYCINAZITHROMYCINDirect_Rx8e6e11fb-eb9e-28ec-e053-2a95a90aa1a32025-01-22Warnings, 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