FDA Approves Unspecified — ORIG Submission by GILEAD SCIENCES INC, Not disclosed in the FDA record.

Key facts

What was approved

FDA's record shows GILEAD SCIENCES INC as the sponsor of Unspecified, with the generic name recorded as unspecified and dosage form unspecified dosage form. A New Drug Application (NDA) is the FDA pathway used to approve a new drug product, typically requiring the sponsor to submit full preclinical and clinical evidence of safety and efficacy for the intended use, along with manufacturing and labeling information. This specific application is submission type ORIG (submission number 1) under application number NDA221443, with a submission status date of 20260827. 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. 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 ORIG submission pathway. A New Drug Application (NDA) is the FDA pathway used to approve a new drug product, typically requiring the sponsor to submit full preclinical and clinical evidence of safety and efficacy for the intended use, along with manufacturing and labeling information. 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. 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.

Gilead Sciences, Inc.’s FDA history

Argus HQ has recorded 3 total FDA actions tied to Gilead Sciences, Inc.: 0 warning letters, 1 recall, 1 approval record, and 1 Form 483 inspection citation.

Frequently asked questions

What is the FDA application number for this submission?

FDA application number NDA221443, submission 1.

What review priority did FDA assign?

FDA designated this submission as: STANDARD.

What dosage form is Unspecified?

Unspecified is formulated as: unspecified dosage form.

What did FDA approve?

FDA's record shows nda approval for Unspecified (unspecified), dosage form unspecified dosage form, sponsored by GILEAD SCIENCES INC, under application number NDA221443. 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.

Related enforcement actions

• Recall: Gilead Sciences, Inc. — Class I recall: Veklury (remdesivir) for injection, 100 mg/vial, Single-Dose Vial, Rx only, Manu… →
• Approval (recent): MACLEODS PHARMS LTD — ANDA approval: SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE (unspecified) →
• Approval (recent): SPIL — ANDA approval: POMALIDOMIDE (unspecified) →
• Approval (recent): QILU PHARM HAINAN — ANDA approval: DIFELIKEFALIN ACETATE (unspecified) →
• Approval (recent): DR REDDYS — ANDA approval: POMALIDOMIDE (unspecified) →
• Approval (recent): NATCO — ANDA approval: EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATE (unspecified) →
• Approval (recent): GILEAD SCIENCES — NDA approval: BIXLENVO (unspecified) →
• Approval (recent): ORBICULAR PHARM TECH — ANDA approval: NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (unspecified) →