Key facts
| Sponsor | BAXTER HLTHCARE CORP |
|---|---|
| Brand name | EPHEDRINE SULFATE |
| Generic name | unspecified |
| Dosage form | SOLUTION |
| Application number | ANDA216740 |
| 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 BAXTER HLTHCARE CORP as the sponsor of EPHEDRINE SULFATE, with the generic name recorded as unspecified and dosage form SOLUTION. 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 ANDA216740, with a submission status date of 20260708. 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.
BAXTER HLTHCARE CORP’s FDA history
Argus HQ has recorded 2 total FDA actions tied to BAXTER HLTHCARE CORP: 0 warning letters, 0 recalls, 2 approval records, and 0 Form 483 inspection citations.
Frequently asked questions
- What is the FDA application number for this submission?
- FDA application number ANDA216740, submission 1.
- What review priority did FDA assign?
- FDA designated this submission as: STANDARD.
- What dosage form is EPHEDRINE SULFATE?
- EPHEDRINE SULFATE is formulated as: SOLUTION.
- What did FDA approve?
- FDA's record shows anda approval for EPHEDRINE SULFATE (unspecified), dosage form SOLUTION, sponsored by BAXTER HLTHCARE CORP, under application number ANDA216740. 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 BAXTER HLTHCARE CORPCompiled 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 EPHEDRINE SULFATE — ORIG Submission by BAXTER HLTHCARE CORP, Not disclosed in the FDA record.. Digital Empire LLC. Retrieved from https://argushq.ai/approval/baxter-hlthcare-anda216740-2026-07-08
"FDA Approves EPHEDRINE SULFATE — ORIG Submission by BAXTER HLTHCARE CORP, Not disclosed in the FDA record.." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/approval/baxter-hlthcare-anda216740-2026-07-08.
Argus HQ Research. "FDA Approves EPHEDRINE SULFATE — ORIG Submission by BAXTER HLTHCARE CORP, Not disclosed in the FDA record.." Digital Empire LLC. Accessed July 15, 2026. https://argushq.ai/approval/baxter-hlthcare-anda216740-2026-07-08.
@misc{argushq_argushq_ai_approval_baxter_hlthcare_anda216740_2026_07_08_2026,
title = {FDA Approves EPHEDRINE SULFATE — ORIG Submission by BAXTER HLTHCARE CORP, Not disclosed in the FDA record.},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/approval/baxter-hlthcare-anda216740-2026-07-08},
note = {Accessed: July 15, 2026}
}Source: FDA.gov — Approvals ↗