Key facts
| Sponsor | ZYDUS PHARMS |
|---|---|
| Brand name | FLUVOXAMINE MALEATE |
| Generic name | unspecified |
| Dosage form | CAPSULE, EXTENDED RELEASE |
| Application number | ANDA220447 |
| Submission number | 1 |
| Submission type | ORIG |
| Review priority | STANDARD |
| Status date | Not disclosed in the FDA record. |
What was approved
FDA's record shows ZYDUS PHARMS as the sponsor of FLUVOXAMINE MALEATE, with the generic name recorded as unspecified and dosage form CAPSULE, 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 ANDA220447, with a submission status date of 20260721. 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.
Regulatory context
This application was reviewed under FDA's ORIG submission pathway. 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. 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.
Frequently asked questions
- What is the FDA application number for this submission?
- FDA application number ANDA220447, submission 1.
- What review priority did FDA assign?
- FDA designated this submission as: STANDARD.
- What dosage form is FLUVOXAMINE MALEATE?
- FLUVOXAMINE MALEATE is formulated as: CAPSULE, EXTENDED RELEASE.
- What did FDA approve?
- FDA's record shows anda approval for FLUVOXAMINE MALEATE (unspecified), dosage form CAPSULE, EXTENDED RELEASE, sponsored by ZYDUS PHARMS, under application number ANDA220447. 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.
Track this company's next FDA filing before it moves the stock.
Free weekly briefing on approvals, warning letters, and inspections.
Related enforcement actions
Full FDA history for ZYDUS PHARMSCompiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder
Cite this record
Reusing this data in reporting or research? Here’s a ready-made citation.
Argus HQ Research (2026). Approval Record: FLUVOXAMINE MALEATE — ZYDUS PHARMS, ORIG (Not disclosed in the FDA record.). Digital Empire Holdings LLC. Retrieved from https://argushq.ai/approval/zydus-pharms-anda220447-2026-07-21
"Approval Record: FLUVOXAMINE MALEATE — ZYDUS PHARMS, ORIG (Not disclosed in the FDA record.)." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/approval/zydus-pharms-anda220447-2026-07-21.
Argus HQ Research. "Approval Record: FLUVOXAMINE MALEATE — ZYDUS PHARMS, ORIG (Not disclosed in the FDA record.)." Digital Empire Holdings LLC. Accessed August 27, 2026. https://argushq.ai/approval/zydus-pharms-anda220447-2026-07-21.
@misc{argushq_argushq_ai_approval_zydus_pharms_anda220447_2026_07_21_2026,
title = {Approval Record: FLUVOXAMINE MALEATE — ZYDUS PHARMS, ORIG (Not disclosed in the FDA record.)},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire Holdings LLC},
url = {https://argushq.ai/approval/zydus-pharms-anda220447-2026-07-21},
note = {Accessed: August 27, 2026}
}Source: FDA.gov — Approvals ↗