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.
Entities
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.

