Key facts
| Sponsor | FRESENIUS KABI USA |
|---|---|
| Brand name | NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE |
| Generic name | unspecified |
| Dosage form | INJECTABLE |
| Application number | ANDA219334 |
| Submission number | 1 |
| Submission type | ORIG |
| Review priority | STANDARD |
| Status date | Not disclosed in the FDA record. |
What was approved
FDA's record shows FRESENIUS KABI USA as the sponsor of NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE, with the generic name recorded as unspecified and dosage form INJECTABLE. 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 ANDA219334, with a submission status date of 20260804. 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 ANDA219334, submission 1.
- What review priority did FDA assign?
- FDA designated this submission as: STANDARD.
- What dosage form is NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE?
- NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE is formulated as: INJECTABLE.
- What did FDA approve?
- FDA's record shows anda approval for NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE (unspecified), dosage form INJECTABLE, sponsored by FRESENIUS KABI USA, under application number ANDA219334. 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 FRESENIUS KABI 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). FRESENIUS KABI USA — FDA ORIG Approval for NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE (Not disclosed in the FDA record.). Digital Empire Holdings LLC. Retrieved from https://argushq.ai/approval/fresenius-kabi-usa-anda219334-2026-08-04
"FRESENIUS KABI USA — FDA ORIG Approval for NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE (Not disclosed in the FDA record.)." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/approval/fresenius-kabi-usa-anda219334-2026-08-04.
Argus HQ Research. "FRESENIUS KABI USA — FDA ORIG Approval for NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE (Not disclosed in the FDA record.)." Digital Empire Holdings LLC. Accessed August 28, 2026. https://argushq.ai/approval/fresenius-kabi-usa-anda219334-2026-08-04.
@misc{argushq_argushq_ai_approval_fresenius_kabi_usa_anda219334_2026_08_04_2026,
title = {FRESENIUS KABI USA — FDA ORIG Approval for NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE (Not disclosed in the FDA record.)},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire Holdings LLC},
url = {https://argushq.ai/approval/fresenius-kabi-usa-anda219334-2026-08-04},
note = {Accessed: August 28, 2026}
}Source: FDA.gov — Approvals ↗