Has LUPIN had other FDA enforcement actions?

Yes. Argus HQ has recorded 5 total FDA actions tied to LUPIN: 0 warning letters, 0 recalls, 5 approval records, and 0 Form 483 inspection citations.

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 2026-09-03; Argus observed and indexed it on 2026-09-11.

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

LUPIN — ANDA approval: MODAFINIL (unspecified)

Name: FDA Drug Approval Record — LUPIN
Creator: Argus HQ
Published: 2026-09-03
License: https://argushq.ai/methodology

Event date: 2026-09-03 00:00:00Z
Observed: 2026-09-11 04:30:41Z
Source ID: ANDA208343-1
Payload hash: 2c7b488205a629a50b4857c1…

Summary

LUPIN received ANDA approval for MODAFINIL (unspecified) on 2026-09-03. Dosage form: TABLET. Application #: ANDA208343.

Entities

LUPIN

View source record ↗

Frequently asked questions

Has LUPIN had other FDA enforcement actions?: Yes. Argus HQ has recorded 5 total FDA actions tied to LUPIN: 0 warning letters, 0 recalls, 5 approval records, and 0 Form 483 inspection citations.
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 2026-09-03; Argus observed and indexed it on 2026-09-11.
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). LUPIN — ANDA approval: MODAFINIL (unspecified). Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-approval-lupin-anda208343-1

MLA

"LUPIN — ANDA approval: MODAFINIL (unspecified)." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/events/fda-approval-lupin-anda208343-1.

Chicago

Argus HQ Research. "LUPIN — ANDA approval: MODAFINIL (unspecified)." Digital Empire Holdings LLC. Accessed September 11, 2026. https://argushq.ai/events/fda-approval-lupin-anda208343-1.

BibTeX

@misc{argushq_argushq_ai_events_fda_approval_lupin_anda208343_1_2026,
  title = {LUPIN — ANDA approval: MODAFINIL (unspecified)},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-approval-lupin-anda208343-1},
  note = {Accessed: September 11, 2026}
}

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