What kind of FDA record is this?

This is an Argus HQ record of a FDA Drug Approval, tagged info severity by Argus HQ. FDA published the underlying record on 2026-07-14; Argus observed and indexed it on 2026-07-18.

Where can I verify this record directly with FDA?

The verbatim FDA source record is the source of truth — Argus HQ links directly to it below. Always confirm against fda.gov before acting.

.hq

fda_approval · anda · info

APOTEX — ANDA approval: AFATINIB DIMALEATE (unspecified)

Name: FDA Drug Approval Record — APOTEX
Creator: Argus HQ
Published: 2026-07-14
License: https://argushq.ai/methodology

Event date: 2026-07-14 00:00:00Z
Observed: 2026-07-18 04:30:40Z
Source ID: ANDA210725-1
Payload hash: 109fdbc37b100801b0df9520…

Summary

APOTEX received ANDA approval for AFATINIB DIMALEATE (unspecified) on 2026-07-14. Dosage form: TABLET. Application #: ANDA210725.

Entities

APOTEX

View source record ↗

Frequently asked questions

What kind of FDA record is this?: This is an Argus HQ record of a FDA Drug Approval, tagged info severity by Argus HQ. FDA published the underlying record on 2026-07-14; Argus observed and indexed it on 2026-07-18.
Where can I verify this record directly with FDA?: The verbatim FDA source record is the source of truth — Argus HQ links directly to it below. Always confirm against fda.gov before acting.

Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder

Cite this record

Reusing this data in reporting or research? Here’s a ready-made citation.

APA

Argus HQ Research (2026). APOTEX — ANDA approval: AFATINIB DIMALEATE (unspecified). Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-approval-apotex-anda210725-1

MLA

"APOTEX — ANDA approval: AFATINIB DIMALEATE (unspecified)." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/events/fda-approval-apotex-anda210725-1.

Chicago

Argus HQ Research. "APOTEX — ANDA approval: AFATINIB DIMALEATE (unspecified)." Digital Empire Holdings LLC. Accessed July 18, 2026. https://argushq.ai/events/fda-approval-apotex-anda210725-1.

BibTeX

@misc{argushq_argushq_ai_events_fda_approval_apotex_anda210725_1_2026,
  title = {APOTEX — ANDA approval: AFATINIB DIMALEATE (unspecified)},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-approval-apotex-anda210725-1},
  note = {Accessed: July 18, 2026}
}

Informational only. Not legal, financial, or medical advice.