Key facts
| Sponsor | CELCUITY INC.. |
|---|---|
| Brand name | REVTORPYK |
| Generic name | unspecified |
| Dosage form | VIAL |
| Application number | NDA219908 |
| Submission number | 1 |
| Submission type | ORIG |
| Review priority | PRIORITY |
| Status date | Not disclosed in the FDA record. |
What was approved
FDA's record shows CELCUITY INC.. as the sponsor of REVTORPYK, with the generic name recorded as unspecified and dosage form VIAL. A New Drug Application (NDA) is the FDA pathway used to approve a new drug product, typically requiring the sponsor to submit full preclinical and clinical evidence of safety and efficacy for the intended use, along with manufacturing and labeling information. This specific application is submission type ORIG (submission number 1) under application number NDA219908, with a submission status date of 20260714. 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. 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. A New Drug Application (NDA) is the FDA pathway used to approve a new drug product, typically requiring the sponsor to submit full preclinical and clinical evidence of safety and efficacy for the intended use, along with manufacturing and labeling information. 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. 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.
CELCUITY INC..’s FDA history
Argus HQ has recorded 1 total FDA action tied to CELCUITY INC..: 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 NDA219908, submission 1.
- What review priority did FDA assign?
- FDA designated this submission as: PRIORITY.
- What dosage form is REVTORPYK?
- REVTORPYK is formulated as: VIAL.
- What did FDA approve?
- FDA's record shows nda approval for REVTORPYK (unspecified), dosage form VIAL, sponsored by CELCUITY INC.., under application number NDA219908. 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.
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Related enforcement actions
Full FDA history for CELCUITY INC..Compiled 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). FDA Approves REVTORPYK — ORIG Submission by CELCUITY INC.., Not disclosed in the FDA record.. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/approval/celcuity-nda219908-2026-07-14
"FDA Approves REVTORPYK — ORIG Submission by CELCUITY INC.., Not disclosed in the FDA record.." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/approval/celcuity-nda219908-2026-07-14.
Argus HQ Research. "FDA Approves REVTORPYK — ORIG Submission by CELCUITY INC.., Not disclosed in the FDA record.." Digital Empire Holdings LLC. Accessed July 18, 2026. https://argushq.ai/approval/celcuity-nda219908-2026-07-14.
@misc{argushq_argushq_ai_approval_celcuity_nda219908_2026_07_14_2026,
title = {FDA Approves REVTORPYK — ORIG Submission by CELCUITY INC.., Not disclosed in the FDA record.},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire Holdings LLC},
url = {https://argushq.ai/approval/celcuity-nda219908-2026-07-14},
note = {Accessed: July 18, 2026}
}Source: FDA.gov — Approvals ↗