Does MICRO LABS have other FDA approval records?

Yes. Argus HQ has recorded 4 total FDA actions tied to MICRO LABS, including 4 approval records.

What is the FDA application number for this submission?

FDA application number ANDA219180, submission 1.

What review priority did FDA assign?

FDA designated this submission as: STANDARD.

What dosage form is PRUCALOPRIDE SUCCINATE?

PRUCALOPRIDE SUCCINATE is formulated as: TABLET.

MICRO LABS — FDA ORIG Approval for PRUCALOPRIDE SUCCINATE (Not disclosed in the FDA record.)

At a glance: MICRO LABS received ANDA approval for PRUCALOPRIDE SUCCINATE (Not disclosed in the FDA record.) on 2026-06-29. Application number ANDA219180, submission type ORIG (submission 1). Dosage form: TABLET. 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.

Key facts

Sponsor	MICRO LABS
Brand name	PRUCALOPRIDE SUCCINATE
Generic name	unspecified
Dosage form	TABLET
Application number	ANDA219180
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 standard review pathway, which typically targets a 10-month review goal measured from submission. 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.

What was approved

FDA's record shows MICRO LABS as the sponsor of PRUCALOPRIDE SUCCINATE, with the generic name recorded as Not disclosed in the FDA record. and dosage form TABLET. 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 ANDA219180, with a submission status date of 20260629. 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.

MICRO LABS’s FDA history

Argus HQ has recorded 4 total FDA actions tied to MICRO LABS: 0 warning letters, 0 recalls, 4 approval records, and 0 Form 483 inspection citations.

Frequently asked questions

Does MICRO LABS have other FDA approval records?: Yes. Argus HQ has recorded 4 total FDA actions tied to MICRO LABS, including 4 approval records.
What is the FDA application number for this submission?: FDA application number ANDA219180, submission 1.
What review priority did FDA assign?: FDA designated this submission as: STANDARD.
What dosage form is PRUCALOPRIDE SUCCINATE?: PRUCALOPRIDE SUCCINATE is formulated as: TABLET.

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Full FDA history for MICRO LABS

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). MICRO LABS — FDA ORIG Approval for PRUCALOPRIDE SUCCINATE (Not disclosed in the FDA record.). Digital Empire LLC. Retrieved from https://argushq.ai/approval/fda-approval-micro-labs-anda219180-1

MLA

"MICRO LABS — FDA ORIG Approval for PRUCALOPRIDE SUCCINATE (Not disclosed in the FDA record.)." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/approval/fda-approval-micro-labs-anda219180-1.

Chicago

Argus HQ Research. "MICRO LABS — FDA ORIG Approval for PRUCALOPRIDE SUCCINATE (Not disclosed in the FDA record.)." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/approval/fda-approval-micro-labs-anda219180-1.

BibTeX

@misc{argushq_argushq_ai_approval_fda_approval_micro_labs_anda219180_1_2026,
  title = {MICRO LABS — FDA ORIG Approval for PRUCALOPRIDE SUCCINATE (Not disclosed in the FDA record.)},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/approval/fda-approval-micro-labs-anda219180-1},
  note = {Accessed: July 13, 2026}
}

Source: FDA.gov — Approvals ↗