What review priority did FDA assign?

FDA designated this submission as: STANDARD.

What dosage form is LINACLOTIDE?

LINACLOTIDE is formulated as: CAPSULE.

ACTAVIS LABS FL — FDA ORIG Approval for LINACLOTIDE (Not disclosed in the FDA record.)

Key facts

Sponsor	ACTAVIS LABS FL
Brand name	LINACLOTIDE
Generic name	unspecified
Dosage form	CAPSULE
Application number	ANDA211255
Submission number	1
Submission type	ORIG
Review priority	STANDARD
Status date	Not disclosed in the FDA record.

The short version: ACTAVIS LABS FL received anda approval for LINACLOTIDE (unspecified) on 2026-09-24. Application number ANDA211255, submission type ORIG (submission 1). Dosage form: CAPSULE. 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.

What was approved

FDA's record shows ACTAVIS LABS FL as the sponsor of LINACLOTIDE, with the generic name recorded as unspecified and dosage form CAPSULE. 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 ANDA211255, with a submission status date of 20260924. 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.

ACTAVIS LABS FL’s FDA history

Argus HQ has recorded 2 total FDA actions tied to ACTAVIS LABS FL: 0 warning letters, 0 recalls, 2 approval records, and 0 Form 483 inspection citations.

Frequently asked questions

What review priority did FDA assign?: FDA designated this submission as: STANDARD.
What dosage form is LINACLOTIDE?: LINACLOTIDE is formulated as: CAPSULE.
What did FDA approve?: FDA's record shows anda approval for LINACLOTIDE (unspecified), dosage form CAPSULE, sponsored by ACTAVIS LABS FL, under application number ANDA211255. 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 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.

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Full FDA history for ACTAVIS LABS FL

Compiled 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.

APA

Argus HQ Research (2026). ACTAVIS LABS FL — FDA ORIG Approval for LINACLOTIDE (Not disclosed in the FDA record.). Digital Empire Holdings LLC. Retrieved from https://argushq.ai/approval/actavis-labs-fl-anda211255-2026-09-24

MLA

"ACTAVIS LABS FL — FDA ORIG Approval for LINACLOTIDE (Not disclosed in the FDA record.)." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/approval/actavis-labs-fl-anda211255-2026-09-24.

Chicago

Argus HQ Research. "ACTAVIS LABS FL — FDA ORIG Approval for LINACLOTIDE (Not disclosed in the FDA record.)." Digital Empire Holdings LLC. Accessed October 12, 2026. https://argushq.ai/approval/actavis-labs-fl-anda211255-2026-09-24.

BibTeX

@misc{argushq_argushq_ai_approval_actavis_labs_fl_anda211255_2026_09_24_2026,
  title = {ACTAVIS LABS FL — FDA ORIG Approval for LINACLOTIDE (Not disclosed in the FDA record.)},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/approval/actavis-labs-fl-anda211255-2026-09-24},
  note = {Accessed: October 12, 2026}
}

Source: FDA.gov — Approvals ↗