FDA.reportPublic FDA data

Application 219371

Type
ANDA
Sponsor
TEVA PHARMACEUTICALS DEVELOPMENT INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002NINTEDANIBNINTEDANIBCAPSULE100MGNoNo
003NINTEDANIBNINTEDANIBCAPSULE25MGNoNo

Source provenance: Browse the complete Orange Book source catalog.

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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