Does MACLEODS PHARMS LTD have other FDA approval records?

This is the only FDA action Argus HQ has on file for MACLEODS PHARMS LTD so far. Argus ingests new FDA records daily.

What is the FDA application number for this submission?

FDA application number ANDA219429, submission 1.

What review priority did FDA assign?

FDA designated this submission as: STANDARD.

What dosage form is SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE?

SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE is formulated as: SOLUTION.

FDA ORIG Approval: SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE — MACLEODS PHARMS LTD (Not disclosed in the FDA record.)

MACLEODS PHARMS LTD received anda approval for SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE (unspecified) on 2026-08-31. Application number ANDA219429, submission type ORIG (submission 1). Dosage form: SOLUTION. 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.

Key facts

Sponsor	MACLEODS PHARMS LTD
Brand name	SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE
Generic name	unspecified
Dosage form	SOLUTION
Application number	ANDA219429
Submission number	1
Submission type	ORIG
Review priority	STANDARD
Status date	Not disclosed in the FDA record.

What was approved

FDA's record shows MACLEODS PHARMS LTD as the sponsor of SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE, with the generic name recorded as unspecified and dosage form SOLUTION. 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 ANDA219429, with a submission status date of 20260831. 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.

MACLEODS PHARMS LTD’s FDA history

Argus HQ has recorded 1 total FDA action tied to MACLEODS PHARMS LTD: 0 warning letters, 0 recalls, 1 approval record, and 0 Form 483 inspection citations.

Frequently asked questions

Does MACLEODS PHARMS LTD have other FDA approval records?: This is the only FDA action Argus HQ has on file for MACLEODS PHARMS LTD so far. Argus ingests new FDA records daily.
What is the FDA application number for this submission?: FDA application number ANDA219429, submission 1.
What review priority did FDA assign?: FDA designated this submission as: STANDARD.
What dosage form is SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE?: SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE is formulated as: SOLUTION.

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Full FDA history for MACLEODS PHARMS LTD

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). FDA ORIG Approval: SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE — MACLEODS PHARMS LTD (Not disclosed in the FDA record.). Digital Empire Holdings LLC. Retrieved from https://argushq.ai/approval/macleods-pharms-anda219429-2026-08-31

MLA

"FDA ORIG Approval: SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE — MACLEODS PHARMS LTD (Not disclosed in the FDA record.)." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/approval/macleods-pharms-anda219429-2026-08-31.

Chicago

Argus HQ Research. "FDA ORIG Approval: SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE — MACLEODS PHARMS LTD (Not disclosed in the FDA record.)." Digital Empire Holdings LLC. Accessed September 5, 2026. https://argushq.ai/approval/macleods-pharms-anda219429-2026-08-31.

BibTeX

@misc{argushq_argushq_ai_approval_macleods_pharms_anda219429_2026_08_31_2026,
  title = {FDA ORIG Approval: SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE — MACLEODS PHARMS LTD (Not disclosed in the FDA record.)},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/approval/macleods-pharms-anda219429-2026-08-31},
  note = {Accessed: September 5, 2026}
}

Source: FDA.gov — Approvals ↗