TOFACITINIB CITRATE (CONCORD BIOTECH LTD): FDA ORIG Approval, Not disclosed in the FDA record.

Key facts

What was approved

FDA's record shows CONCORD BIOTECH LTD as the sponsor of TOFACITINIB CITRATE, 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 ANDA218821, with a submission status date of 20260609. 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.

CONCORD BIOTECH LTD’s FDA history

Argus HQ has recorded 1 total FDA action tied to CONCORD BIOTECH LTD: 0 warning letters, 0 recalls, 1 approval record, 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 TOFACITINIB CITRATE?

TOFACITINIB CITRATE is formulated as: TABLET.

What did FDA approve?

FDA's record shows ANDA approval for TOFACITINIB CITRATE (Not disclosed in the FDA record.), dosage form TABLET, sponsored by CONCORD BIOTECH LTD, under application number ANDA218821. FDA publishes approval and submission records so physicians, competitors, and investors can track which sponsors and products have cleared a given regulatory pathway.

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.

Related enforcement actions