Changeflow GovPing Healthcare & Life Sciences Appco Pharma LLC Suitability Petition
Routine Guidance Added Final

Appco Pharma LLC Suitability Petition

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Summary

The Food and Drug Administration (FDA) has received a suitability petition from Appco Pharma LLC. The petition is related to drug manufacturing and regulatory filings.

Published by FDA on regulations.gov . Detected, standardized, and enriched by GovPing. Review our methodology and editorial standards .
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What changed

The Food and Drug Administration (FDA) has received a suitability petition filed by Appco Pharma LLC. This filing indicates a specific request or submission made by the pharmaceutical company to the agency, likely concerning aspects of drug development, manufacturing, or marketing.

While the document itself is not available for download, its existence as a filed petition suggests that Appco Pharma LLC is seeking agency review or approval on a particular matter. Compliance officers should note that this is a filing event, and further details regarding the petition's content or any subsequent FDA actions would require access to the actual document or further announcements.

Archived snapshot

Mar 28, 2026

GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.

Content

There are no documents available to view or download

Attachments 1

Suitability Petition from Appco Pharma LLC

More Information
- Author(s) CDER
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Related changes

Favicon for www.regulations.gov Suitability Petition - Emprise Pharma on Behalf of Shandong New Time
Routine Apr 10, 2026 • Regs.gov: Food and Drug Administration • Healthcare & Life Sciences
Favicon for www.regulations.gov FDA Petition Attachment - Content Restricted
Routine Apr 03, 2026 • Regs.gov: Food and Drug Administration • Healthcare & Life Sciences
Favicon for www.regulations.gov FDA DMB Acknowledgement Letter to Emprise Pharma LLC
Routine Apr 10, 2026 • Regs.gov: Food and Drug Administration • Healthcare & Life Sciences

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Source

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Classification

Agency
FDA
Instrument
Guidance
Legal weight
Non-binding
Stage
Final
Change scope
Minor
Document ID
FDA-2026-P-3242-0001
Docket
FDA-2026-P-3242-0001

Who this affects

Applies to
Drug manufacturers
Industry sector
3254 Pharmaceutical Manufacturing
Activity scope
Drug Manufacturing Regulatory Filings
Geographic scope
United States US

Taxonomy

Primary area
Pharmaceuticals
Operational domain
Compliance
Compliance frameworks
FDA 21 CFR Part 11 GxP
Topics
Drug Approval Regulatory Filings

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