Does AUROBINDO PHARMA LTD have other FDA approval records?

Yes. Argus HQ has recorded 7 total FDA actions tied to AUROBINDO PHARMA LTD, including 7 approval records.

What is the FDA application number for this submission?

FDA application number ANDA213631, submission 1.

What review priority did FDA assign?

FDA designated this submission as: STANDARD.

SACUBITRIL AND VALSARTAN (AUROBINDO PHARMA LTD): FDA ORIG Approval, Not disclosed in the FDA record.

Key facts

Sponsor	AUROBINDO PHARMA LTD
Brand name	SACUBITRIL AND VALSARTAN
Generic name	unspecified
Dosage form	TABLET
Application number	ANDA213631
Submission number	1
Submission type	ORIG
Review priority	STANDARD
Status date	Not disclosed in the FDA record.

The short version: AUROBINDO PHARMA LTD received anda approval for SACUBITRIL AND VALSARTAN (unspecified) on 2026-09-02. Application number ANDA213631, 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. 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 AUROBINDO PHARMA LTD as the sponsor of SACUBITRIL AND VALSARTAN, with the generic name recorded as unspecified 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 ANDA213631, with a submission status date of 20260902. 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.

AUROBINDO PHARMA LTD’s FDA history

Argus HQ has recorded 7 total FDA actions tied to AUROBINDO PHARMA LTD: 0 warning letters, 0 recalls, 7 approval records, and 0 Form 483 inspection citations.

Frequently asked questions

Is this product available now?: FDA's record lists a submission status date of 20260902. 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 AUROBINDO PHARMA LTD have other FDA approval records?: Yes. Argus HQ has recorded 7 total FDA actions tied to AUROBINDO PHARMA LTD, including 7 approval records.
What is the FDA application number for this submission?: FDA application number ANDA213631, submission 1.
What review priority did FDA assign?: FDA designated this submission as: STANDARD.

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Full FDA history for AUROBINDO PHARMA 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). SACUBITRIL AND VALSARTAN (AUROBINDO PHARMA LTD): FDA ORIG Approval, Not disclosed in the FDA record.. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/approval/aurobindo-pharma-anda213631-2026-09-02

MLA

"SACUBITRIL AND VALSARTAN (AUROBINDO PHARMA LTD): FDA ORIG Approval, Not disclosed in the FDA record.." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/approval/aurobindo-pharma-anda213631-2026-09-02.

Chicago

Argus HQ Research. "SACUBITRIL AND VALSARTAN (AUROBINDO PHARMA LTD): FDA ORIG Approval, Not disclosed in the FDA record.." Digital Empire Holdings LLC. Accessed September 9, 2026. https://argushq.ai/approval/aurobindo-pharma-anda213631-2026-09-02.

BibTeX

@misc{argushq_argushq_ai_approval_aurobindo_pharma_anda213631_2026_09_02_2026,
  title = {SACUBITRIL AND VALSARTAN (AUROBINDO PHARMA LTD): FDA ORIG Approval, Not disclosed in the FDA record.},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/approval/aurobindo-pharma-anda213631-2026-09-02},
  note = {Accessed: September 9, 2026}
}

Source: FDA.gov — Approvals ↗