FDA.reportPublic FDA data

Application 212581

Type
ANDA
Sponsor
TARO PHARM INDS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AZELAIC ACIDAZELAIC ACIDAEROSOL, FOAM;TOPICAL15%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 1 ยท 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
10% Azelaic AcidAZELAIC ACID CREAMGuangzhou Ariel Medical Technology Co., Ltd.55b03daa-b6d4-9edf-e063-6394a90ac4d12026-07-03WarningsName fallback
generic name: AZELAIC ACID
Azelaic Acid GelAZELAIC ACIDBryant Ranch Prepack9c151fc7-cb0b-4931-9c1b-0c29f46ac21f2026-05-21Warnings, Adverse reactionsName fallback
generic name: AZELAIC ACID
14% Azelaic Acid AcneAZELAIC ACIDGuangdong Bisutang Biotechnology Co., Ltd.4ccaa734-83be-611b-e063-6294a90ab3bf2026-03-11WarningsName fallback
generic name: AZELAIC ACID
Azelaic Acid GelAZELAIC ACIDEncube Ethicals, Inc.ab3f174c-a3c4-4ae9-b0bc-954efaadf8de2025-12-24Warnings, Adverse reactionsName fallback
generic name: AZELAIC ACID
Azelaic AcidAZELAIC ACIDSun Pharmaceutical Industries, Inc.d4e9e95d-1ebd-44df-a91e-59819715659c2025-08-22Warnings, Adverse reactionsName fallback
brand name: Azelaic Acid
generic name: AZELAIC ACID
AZELEXAZELAIC ACIDAlmirall, LLCebdfcaf7-b5d6-47e1-be87-ccaba4b97e752024-03-04Warnings, Adverse reactionsName fallback
generic name: AZELAIC ACID
azelaic acidAZELAIC ACIDActavis Pharma, Inc.66298d50-d4e2-4852-bbab-581389c488cb2022-05-30Warnings, Adverse reactionsName fallback
brand name: azelaic acid
generic name: AZELAIC ACID
azelaic acidAZELAIC ACIDGlenmark Pharmaceuticals Inc., USA0b5ab22e-c78a-4429-9a76-a4ba2d11fcde2021-12-23Warnings, Adverse reactionsName fallback
brand name: azelaic acid
generic name: AZELAIC ACID
Azelaic Acid GelAZELAIC ACIDSandoz Inc.66178511-5c1a-4ecd-bc98-2ceb54e710ac2021-11-11Warnings, Adverse reactionsName fallback
generic name: AZELAIC ACID
FINACEA FOAMAZELAIC ACIDLEO Pharma Inc.9fabd24e-4c3b-49a0-aa5f-c8d75ae675722020-12-08Warnings, Adverse reactionsName fallback
generic name: AZELAIC ACID

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
67424ORIG2021-05-06