ACTAVIS LABS FL: Generic drug approval for LINACLOTIDE

ACTAVIS LABS FL: Generic drug approval for LINACLOTIDE. Dated 42 days ago, it serves as a historical benchmark. Score 45/100. As of 2026-11-04, from openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration).

Data as of · Compiled by Zalwin from openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration)

Free preview: all 7 published fields of this record are shown below. Locked: 499 related FdaApprovalPulse records and the 4-column CSV export.

FieldValue
SponsorACTAVIS LABS FL
ProductLINACLOTIDE
Generic / ingredientLINACLOTIDE
ApprovalGeneric drug approval (ANDA)
ApplicationANDA211255
Decided2026-09-24
Panel / classCAPSULE, ORAL
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  • Source agency: openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration)
  • Record date: 2026-09-24
  • Data refreshed: 2026-11-04
  • Refunds on request within 14 days

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LIVE PUBLIC DATA Source: openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration) · Last refreshed: Wed, 04 Nov 2026 06:06:18 GMT

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45 / 100 Score

  • A generic launch.

What is the FdaApprovalPulse record for ACTAVIS LABS FL?

The FDA approved LINACLOTIDE (ANDA211255) for ACTAVIS LABS FL on 2026-09-24: generic drug approval (ANDA).

How does ACTAVIS LABS FL compare to other FdaApprovalPulse records?

It is 42 days old, still within a typical 45-day follow-up window.

ACTAVIS LABS FL vs. top 3 peers

OrganizationRecord date
ACTAVIS LABS FL2026-09-24
ALEMBIC2026-10-28
NEURORX2026-10-28
ALEMBIC2026-10-26

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From openFDA (PMA and Drugs@FDA). openFDA can lag FDA decisions by days to weeks. Drug supplement types follow the FDA submission class (labeling and REMS, manufacturing/CMC, efficacy, other). Company and product level only. Verify on FDA databases before relying on an approval.

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