MYLAN LABS LTD — FDA ORIG Approval for FERRIC CARBOXYMALTOSE (Not disclosed in the FDA record.)

Key facts

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.

What was approved

FDA's record shows MYLAN LABS LTD as the sponsor of FERRIC CARBOXYMALTOSE, with the generic name recorded as Not disclosed in the FDA record. 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 ANDA212572, with a submission status date of 20260625. 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.

MYLAN LABS LTD’s FDA history

Argus HQ has recorded 1 total FDA action tied to MYLAN LABS LTD: 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 ANDA212572, submission 1.

What review priority did FDA assign?

FDA designated this submission as: STANDARD.

What dosage form is FERRIC CARBOXYMALTOSE?

FERRIC CARBOXYMALTOSE is formulated as: SOLUTION.

What did FDA approve?

FDA's record shows ANDA approval for FERRIC CARBOXYMALTOSE (Not disclosed in the FDA record.), dosage form SOLUTION, sponsored by MYLAN LABS LTD, under application number ANDA212572. 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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