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fda_approval · anda · info

HETERO LABS LTD V — ANDA approval: AFATINIB DIMALEATE (unspecified)

Event date
2026-07-14 00:00:00Z
Observed
2026-07-18 04:30:40Z
Source ID
ANDA210750-1
Payload hash
debf8fad897668a12dad5f68

Summary

HETERO LABS LTD V received ANDA approval for AFATINIB DIMALEATE (unspecified) on 2026-07-14. Dosage form: TABLET. Application #: ANDA210750.

Frequently asked questions

Has HETERO LABS LTD V had other FDA enforcement actions?
This is the only FDA action Argus HQ has on file for HETERO LABS LTD V as of 2026-07-18. Argus ingests new FDA enforcement records daily.
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). HETERO LABS LTD V — ANDA approval: AFATINIB DIMALEATE (unspecified). Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-approval-hetero-labs-ltd-v-anda210750-1
MLA
"HETERO LABS LTD V — ANDA approval: AFATINIB DIMALEATE (unspecified)." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/events/fda-approval-hetero-labs-ltd-v-anda210750-1.
Chicago
Argus HQ Research. "HETERO LABS LTD V — ANDA approval: AFATINIB DIMALEATE (unspecified)." Digital Empire Holdings LLC. Accessed July 18, 2026. https://argushq.ai/events/fda-approval-hetero-labs-ltd-v-anda210750-1.
BibTeX
@misc{argushq_argushq_ai_events_fda_approval_hetero_labs_ltd_v_anda210750_1_2026,
  title = {HETERO LABS LTD V — ANDA approval: AFATINIB DIMALEATE (unspecified)},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-approval-hetero-labs-ltd-v-anda210750-1},
  note = {Accessed: July 18, 2026}
}

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