FDA.reportPublic FDA data

Application 212732

Type
ANDA
Sponsor
ACCORD HLTHCARE INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NINTEDANIBNINTEDANIBCAPSULE;ORALEQ 100MG BASENoNo
002NINTEDANIBNINTEDANIBCAPSULE;ORALEQ 150MG BASENoNo

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 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NintedanibNINTEDANIBEdenbridge Pharmaceuticals LLC.43dae004-eaf6-4411-8c3d-db7ab2c3b41e2026-07-29Warnings, Adverse reactionsName fallback
brand name: Nintedanib
generic name: NINTEDANIB
nintedanibNINTEDANIBAvKARE572722d7-338a-e4d2-e063-6394a90a257c2026-07-21Warnings, Adverse reactionsName fallback
brand name: nintedanib
generic name: NINTEDANIB
nintedanibNINTEDANIBGlenmark Pharmaceuticals Inc., USAb14164fb-0276-4ad1-a5ff-400ab9e292da2026-07-10Warnings, Adverse reactionsName fallback
brand name: nintedanib
generic name: NINTEDANIB
nintedanibNINTEDANIBEPIC PHARMA LLC0e12f080-fcb4-465f-b988-4fa2c79f49aa2026-07-09Warnings, Adverse reactionsName fallback
brand name: nintedanib
generic name: NINTEDANIB
NintedanibNINTEDANIBGolden State Medical Supply, Inc.4ecf7f05-4a95-b98c-e063-6394a90ab8962026-06-16Warnings, Adverse reactionsName fallback
brand name: Nintedanib
generic name: NINTEDANIB
Nintedanib Capsules, 100 mg and 150 mgNINTEDANIBEXELAN PHARMACEUTICALS INC.60d8104e-cb6c-4f4f-8159-95ed57346ffa2026-04-21Warnings, Adverse reactionsName fallback
generic name: NINTEDANIB
NintedanibNINTEDANIBCipla USA Inc.4d017c42-a823-452d-bc6f-0491dd9823e32026-04-02Warnings, Adverse reactionsName fallback
brand name: Nintedanib
generic name: NINTEDANIB
NintedanibNINTEDANIBApotex Corp.b72b26c3-7731-80c0-734b-a5f53a1d89ae2026-03-20Warnings, Adverse reactionsName fallback
brand name: Nintedanib
generic name: NINTEDANIB
nintedanibNINTEDANIBSandoz Inc751c3473-35d6-47d6-b405-af16a989716c2026-01-20Warnings, Adverse reactionsName fallback
brand name: nintedanib
generic name: NINTEDANIB
NintedanibNINTEDANIBDr. Reddy's Laboratories Inc.88f8600d-0974-51ca-6f8e-28c48a379e082025-11-20Warnings, Adverse reactionsName fallback
brand name: Nintedanib
generic name: NINTEDANIB
OfevNINTEDANIBBoehringer Ingelheim Pharmaceuticals, Inc.da1c9f37-779e-4682-816f-93d0faa4cfc92025-11-20Warnings, Adverse reactionsName fallback
generic name: NINTEDANIB

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
64608ORIG2020-09-18