FDA Approves Unspecified — ORIG Submission by BAXTER HLTHCARE CORP, Not disclosed in the FDA record.

Key facts

What was approved

FDA's record shows BAXTER HLTHCARE CORP 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 NDA218524, with a submission status date of 20260814. 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.

BAXTER HLTHCARE CORP’s FDA history

Argus HQ has recorded 5 total FDA actions tied to BAXTER HLTHCARE CORP: 0 warning letters, 0 recalls, 5 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 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 BAXTER HLTHCARE CORP, under application number NDA218524. 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?

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.

Related enforcement actions

• Approval: BAXTER HLTHCARE CORP — ANDA approval: LEVETIRACETAM (unspecified) →
• Approval: BAXTER HLTHCARE CORP — ANDA approval: DIAZEPAM (unspecified) →
• Approval: BAXTER HLTHCARE CORP — ANDA approval: EPHEDRINE SULFATE (unspecified) →