Key facts
| Sponsor | ASPIRO |
|---|---|
| Brand name | CYANOCOBALAMIN |
| Generic name | unspecified |
| Dosage form | INJECTABLE |
| Application number | ANDA219820 |
| Submission number | 1 |
| Submission type | ORIG |
| Review priority | STANDARD |
| Status date | Not disclosed in the FDA record. |
What was approved
FDA's record shows ASPIRO as the sponsor of CYANOCOBALAMIN, 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 ANDA219820, 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.
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.
ASPIRO’s FDA history
Argus HQ has recorded 1 total FDA action tied to ASPIRO: 0 warning letters, 0 recalls, 1 approval record, and 0 Form 483 inspection citations.
Frequently asked questions
- What does the submission type mean?
- 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.
- Is this product available now?
- FDA's record lists a submission status date of 20260708. 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 ASPIRO have other FDA approval records?
- This is the only FDA action Argus HQ has on file for ASPIRO so far. Argus ingests new FDA records daily.
- What is the FDA application number for this submission?
- FDA application number ANDA219820, submission 1.
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Related enforcement actions
Full FDA history for ASPIROCompiled 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). CYANOCOBALAMIN (ASPIRO): FDA ORIG Approval, Not disclosed in the FDA record.. Digital Empire LLC. Retrieved from https://argushq.ai/approval/aspiro-anda219820-2026-07-08
"CYANOCOBALAMIN (ASPIRO): FDA ORIG Approval, Not disclosed in the FDA record.." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/approval/aspiro-anda219820-2026-07-08.
Argus HQ Research. "CYANOCOBALAMIN (ASPIRO): FDA ORIG Approval, Not disclosed in the FDA record.." Digital Empire LLC. Accessed July 15, 2026. https://argushq.ai/approval/aspiro-anda219820-2026-07-08.
@misc{argushq_argushq_ai_approval_aspiro_anda219820_2026_07_08_2026,
title = {CYANOCOBALAMIN (ASPIRO): FDA ORIG Approval, Not disclosed in the FDA record.},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/approval/aspiro-anda219820-2026-07-08},
note = {Accessed: July 15, 2026}
}Source: FDA.gov — Approvals ↗