What review priority did FDA assign?

FDA designated this submission as: STANDARD.

What dosage form is DIFELIKEFALIN ACETATE?

DIFELIKEFALIN ACETATE is formulated as: SOLUTION.

DIFELIKEFALIN ACETATE (QILU PHARM HAINAN): FDA ORIG Approval, Not disclosed in the FDA record.

At a glance: QILU PHARM HAINAN received anda approval for DIFELIKEFALIN ACETATE (unspecified) on 2026-08-31. Application number ANDA220919, submission type ORIG (submission 1). Dosage form: SOLUTION. 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. 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	QILU PHARM HAINAN
Brand name	DIFELIKEFALIN ACETATE
Generic name	unspecified
Dosage form	SOLUTION
Application number	ANDA220919
Submission number	1
Submission type	ORIG
Review priority	STANDARD
Status date	Not disclosed in the FDA record.

Regulatory context

This application was reviewed under FDA's ORIG submission pathway. 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. 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.

What was approved

FDA's record shows QILU PHARM HAINAN as the sponsor of DIFELIKEFALIN ACETATE, with the generic name recorded as unspecified and dosage form SOLUTION. 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 ANDA220919, with a submission status date of 20260831. 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. 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.

QILU PHARM HAINAN’s FDA history

Argus HQ has recorded 2 total FDA actions tied to QILU PHARM HAINAN: 0 warning letters, 0 recalls, 2 approval records, and 0 Form 483 inspection citations.

Frequently asked questions

What review priority did FDA assign?: FDA designated this submission as: STANDARD.
What dosage form is DIFELIKEFALIN ACETATE?: DIFELIKEFALIN ACETATE is formulated as: SOLUTION.
What did FDA approve?: FDA's record shows anda approval for DIFELIKEFALIN ACETATE (unspecified), dosage form SOLUTION, sponsored by QILU PHARM HAINAN, under application number ANDA220919. 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.
What does the submission type mean?: 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.

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Full FDA history for QILU PHARM HAINAN

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). DIFELIKEFALIN ACETATE (QILU PHARM HAINAN): FDA ORIG Approval, Not disclosed in the FDA record.. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/approval/qilu-pharm-hainan-anda220919-2026-08-31

MLA

"DIFELIKEFALIN ACETATE (QILU PHARM HAINAN): FDA ORIG Approval, Not disclosed in the FDA record.." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/approval/qilu-pharm-hainan-anda220919-2026-08-31.

Chicago

Argus HQ Research. "DIFELIKEFALIN ACETATE (QILU PHARM HAINAN): FDA ORIG Approval, Not disclosed in the FDA record.." Digital Empire Holdings LLC. Accessed September 5, 2026. https://argushq.ai/approval/qilu-pharm-hainan-anda220919-2026-08-31.

BibTeX

@misc{argushq_argushq_ai_approval_qilu_pharm_hainan_anda220919_2026_08_31_2026,
  title = {DIFELIKEFALIN ACETATE (QILU PHARM HAINAN): FDA ORIG Approval, Not disclosed in the FDA record.},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/approval/qilu-pharm-hainan-anda220919-2026-08-31},
  note = {Accessed: September 5, 2026}
}

Source: FDA.gov — Approvals ↗