FDA Approves BUPROPION HYDROCHLORIDE — ORIG Submission by MACLEODS PHARMS LTD, Not disclosed in the FDA record.

Key facts

What was approved

FDA's record shows MACLEODS PHARMS LTD as the sponsor of BUPROPION HYDROCHLORIDE, with the generic name recorded as Not disclosed in the FDA record. and dosage form TABLET, EXTENDED RELEASE. 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 ANDA218567, with a submission status date of 20260623. 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.

MACLEODS PHARMS LTD’s FDA history

Argus HQ has recorded 3 total FDA actions tied to MACLEODS PHARMS LTD: 0 warning letters, 0 recalls, 3 approval records, and 0 Form 483 inspection citations.

Frequently asked questions

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.

Is this product available now?

FDA's record lists a submission status date of 20260623. Availability, pricing, and distribution details beyond the submission status date are Not disclosed in the FDA record. FDA publishes approval and submission records so physicians, competitors, and investors can track which sponsors and products have cleared a given regulatory pathway.

Does MACLEODS PHARMS LTD have other FDA approval records?

Yes. Argus HQ has recorded 3 total FDA actions tied to MACLEODS PHARMS LTD, including 3 approval records.

What is the FDA application number for this submission?

FDA application number ANDA218567, submission 1.

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