Does NOVITIUM PHARMA have other FDA approval records?

Yes. Argus HQ has recorded 6 total FDA actions tied to NOVITIUM PHARMA, including 6 approval records.

What is the FDA application number for this submission?

FDA application number ANDA218687, submission 1.

FDA ORIG Approval: ESOMEPRAZOLE MAGNESIUM — NOVITIUM PHARMA (Not disclosed in the FDA record.)

NOVITIUM PHARMA received anda approval for ESOMEPRAZOLE MAGNESIUM (unspecified) on 2026-09-25. Application number ANDA218687, submission type ORIG (submission 1). Dosage form: FOR SUSPENSION, DELAYED RELEASE. 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	NOVITIUM PHARMA
Brand name	ESOMEPRAZOLE MAGNESIUM
Generic name	unspecified
Dosage form	FOR SUSPENSION, DELAYED RELEASE
Application number	ANDA218687
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 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 NOVITIUM PHARMA as the sponsor of ESOMEPRAZOLE MAGNESIUM, with the generic name recorded as unspecified and dosage form FOR SUSPENSION, DELAYED RELEASE. 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 ANDA218687, with a submission status date of 20260925. 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.

NOVITIUM PHARMA’s FDA history

Argus HQ has recorded 6 total FDA actions tied to NOVITIUM PHARMA: 0 warning letters, 0 recalls, 6 approval records, and 0 Form 483 inspection citations.

Frequently asked questions

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.
Is this product available now?: FDA's record lists a submission status date of 20260925. Availability, pricing, and distribution details beyond the submission status date are Not disclosed in the FDA record. 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.
Does NOVITIUM PHARMA have other FDA approval records?: Yes. Argus HQ has recorded 6 total FDA actions tied to NOVITIUM PHARMA, including 6 approval records.
What is the FDA application number for this submission?: FDA application number ANDA218687, submission 1.

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Full FDA history for NOVITIUM PHARMA

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: ESOMEPRAZOLE MAGNESIUM — NOVITIUM PHARMA (Not disclosed in the FDA record.). Digital Empire Holdings LLC. Retrieved from https://argushq.ai/approval/novitium-pharma-anda218687-2026-09-25

MLA

"FDA ORIG Approval: ESOMEPRAZOLE MAGNESIUM — NOVITIUM PHARMA (Not disclosed in the FDA record.)." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/approval/novitium-pharma-anda218687-2026-09-25.

Chicago

Argus HQ Research. "FDA ORIG Approval: ESOMEPRAZOLE MAGNESIUM — NOVITIUM PHARMA (Not disclosed in the FDA record.)." Digital Empire Holdings LLC. Accessed October 3, 2026. https://argushq.ai/approval/novitium-pharma-anda218687-2026-09-25.

BibTeX

@misc{argushq_argushq_ai_approval_novitium_pharma_anda218687_2026_09_25_2026,
  title = {FDA ORIG Approval: ESOMEPRAZOLE MAGNESIUM — NOVITIUM PHARMA (Not disclosed in the FDA record.)},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/approval/novitium-pharma-anda218687-2026-09-25},
  note = {Accessed: October 3, 2026}
}

Source: FDA.gov — Approvals ↗