What is the FDA application number for this submission?

FDA application number ANDA219464, submission 1.

What review priority did FDA assign?

FDA designated this submission as: STANDARD.

What dosage form is EVEROLIMUS?

EVEROLIMUS is formulated as: TABLET.

What did FDA approve?

FDA's record shows ANDA approval for EVEROLIMUS (Not disclosed in the FDA record.), dosage form TABLET, sponsored by I3 PHARMS, under application number ANDA219464. FDA publishes approval and submission records so physicians, competitors, and investors can track which sponsors and products have cleared a given regulatory pathway.

EVEROLIMUS (I3 PHARMS): FDA ORIG Approval, Not disclosed in the FDA record.

At a glance: I3 PHARMS received ANDA approval for EVEROLIMUS (Not disclosed in the FDA record.) on 2026-06-30. Application number ANDA219464, submission type ORIG (submission 1). Dosage form: TABLET. FDA publishes approval and submission records so physicians, competitors, and investors can track which sponsors and products have cleared a given regulatory pathway. An approval reflects FDA's determination on the application as submitted; any post-approval changes to manufacturing, labeling, or use typically require a separate supplemental submission.

Key facts

Sponsor	I3 PHARMS
Brand name	EVEROLIMUS
Generic name	unspecified
Dosage form	TABLET
Application number	ANDA219464
Submission number	1
Submission type	ORIG
Review priority	STANDARD
Status date	Not disclosed in the FDA record.

What was approved

FDA's record shows I3 PHARMS as the sponsor of EVEROLIMUS, with the generic name recorded as Not disclosed in the FDA record. and dosage form TABLET. An Abbreviated New Drug Application (ANDA) is the FDA pathway used to approve generic drug products. Instead of repeating the clinical efficacy and safety trials already performed for the original branded product, an ANDA sponsor must demonstrate that its generic version is bioequivalent to an already-approved reference listed drug and meets the same identity, strength, quality, purity, and manufacturing standards. This specific application is submission type ORIG (submission number 1) under application number ANDA219464, with a submission status date of 20260630. FDA publishes approval and submission records so physicians, competitors, and investors can track which sponsors and products have cleared a given regulatory pathway. An approval reflects FDA's determination on the application as submitted; any post-approval changes to manufacturing, labeling, or use typically require a separate supplemental submission. This record is drawn directly from FDA's own approvals database rather than from company press materials. FDA publishes approval and submission records so physicians, competitors, and investors can track which sponsors and products have cleared a given regulatory pathway. An approval reflects FDA's determination on the application as submitted; any post-approval changes to manufacturing, labeling, or use typically require a separate supplemental submission.

Regulatory context

This application was reviewed under FDA's standard review pathway, which typically targets a 10-month review goal measured from submission. An Abbreviated New Drug Application (ANDA) is the FDA pathway used to approve generic drug products. Instead of repeating the clinical efficacy and safety trials already performed for the original branded product, an ANDA sponsor must demonstrate that its generic version is bioequivalent to an already-approved reference listed drug and meets the same identity, strength, quality, purity, and manufacturing standards. FDA approval of an application does not itself guarantee ongoing marketing; sponsors remain subject to post-approval manufacturing inspections and adverse-event reporting requirements.

I3 PHARMS’s FDA history

Argus HQ has recorded 1 total FDA action tied to I3 PHARMS: 0 warning letters, 0 recalls, 1 approval record, and 0 Form 483 inspection citations.

Frequently asked questions

What is the FDA application number for this submission?: FDA application number ANDA219464, submission 1.
What review priority did FDA assign?: FDA designated this submission as: STANDARD.
What dosage form is EVEROLIMUS?: EVEROLIMUS is formulated as: TABLET.
What did FDA approve?: FDA's record shows ANDA approval for EVEROLIMUS (Not disclosed in the FDA record.), dosage form TABLET, sponsored by I3 PHARMS, under application number ANDA219464. FDA publishes approval and submission records so physicians, competitors, and investors can track which sponsors and products have cleared a given regulatory pathway.

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Full FDA history for I3 PHARMS

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). EVEROLIMUS (I3 PHARMS): FDA ORIG Approval, Not disclosed in the FDA record.. Digital Empire LLC. Retrieved from https://argushq.ai/approval/fda-approval-i3-pharms-anda219464-1

MLA

"EVEROLIMUS (I3 PHARMS): FDA ORIG Approval, Not disclosed in the FDA record.." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/approval/fda-approval-i3-pharms-anda219464-1.

Chicago

Argus HQ Research. "EVEROLIMUS (I3 PHARMS): FDA ORIG Approval, Not disclosed in the FDA record.." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/approval/fda-approval-i3-pharms-anda219464-1.

BibTeX

@misc{argushq_argushq_ai_approval_fda_approval_i3_pharms_anda219464_1_2026,
  title = {EVEROLIMUS (I3 PHARMS): FDA ORIG Approval, Not disclosed in the FDA record.},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/approval/fda-approval-i3-pharms-anda219464-1},
  note = {Accessed: July 13, 2026}
}

Source: FDA.gov — Approvals ↗