Application 219227

Type
ANDA
Sponsor
APOTEX

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A219227-001NINTEDANIB ESYLATENINTEDANIB ESYLATEEQ 100MG BASECAPSULE / ORALAB2026-04-02
A219227-002NINTEDANIB ESYLATENINTEDANIB ESYLATEEQ 150MG BASECAPSULE / ORALAB2026-04-02

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A219227-001AB
A219227-002AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219227-001NINTEDANIB ESYLATEEQ 100MG BASECAPSULE / ORALAB2026-04-02a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219227-002NINTEDANIB ESYLATEEQ 150MG BASECAPSULE / ORALAB2026-04-02a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219227-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219227-002AB1a50c72e98297…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NintedanibNINTEDANIBApotex Corp.b72b26c3-7731-80c0-734b-a5f53a1d89ae2026-03-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 219227
application number: ANDA219227

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85638ORIG 2026-04-06