Key facts
| Sponsor | TEVA PHARMS USA |
|---|---|
| Brand name | TOFACITINIB CITRATE |
| Generic name | unspecified |
| Dosage form | TABLET, EXTENDED RELEASE |
| Application number | ANDA209813 |
| Submission number | 1 |
| Submission type | ORIG |
| Review priority | STANDARD |
| Status date | Not disclosed in the FDA record. |
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.
What was approved
FDA's record shows TEVA PHARMS USA as the sponsor of TOFACITINIB CITRATE, with the generic name recorded as unspecified 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 ANDA209813, with a submission status date of 20260817. 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.
TEVA PHARMS USA’s FDA history
Argus HQ has recorded 3 total FDA actions tied to TEVA PHARMS USA: 0 warning letters, 0 recalls, 3 approval records, and 0 Form 483 inspection citations.
Frequently asked questions
- Is this product available now?
- FDA's record lists a submission status date of 20260817. 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. 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.
- Does TEVA PHARMS USA have other FDA approval records?
- Yes. Argus HQ has recorded 3 total FDA actions tied to TEVA PHARMS USA, including 3 approval records.
- What is the FDA application number for this submission?
- FDA application number ANDA209813, submission 1.
- What review priority did FDA assign?
- FDA designated this submission as: STANDARD.
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Related enforcement actions
Full FDA history for TEVA PHARMS USACompiled 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). TEVA PHARMS USA — FDA ORIG Approval for TOFACITINIB CITRATE (Not disclosed in the FDA record.). Digital Empire Holdings LLC. Retrieved from https://argushq.ai/approval/teva-pharms-usa-anda209813-2026-08-17
"TEVA PHARMS USA — FDA ORIG Approval for TOFACITINIB CITRATE (Not disclosed in the FDA record.)." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/approval/teva-pharms-usa-anda209813-2026-08-17.
Argus HQ Research. "TEVA PHARMS USA — FDA ORIG Approval for TOFACITINIB CITRATE (Not disclosed in the FDA record.)." Digital Empire Holdings LLC. Accessed August 28, 2026. https://argushq.ai/approval/teva-pharms-usa-anda209813-2026-08-17.
@misc{argushq_argushq_ai_approval_teva_pharms_usa_anda209813_2026_08_17_2026,
title = {TEVA PHARMS USA — FDA ORIG Approval for TOFACITINIB CITRATE (Not disclosed in the FDA record.)},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire Holdings LLC},
url = {https://argushq.ai/approval/teva-pharms-usa-anda209813-2026-08-17},
note = {Accessed: August 28, 2026}
}Source: FDA.gov — Approvals ↗