What is the FDA application number for this submission?

FDA application number ANDA207399, submission 1.

What review priority did FDA assign?

FDA designated this submission as: STANDARD.

What dosage form is MILNACIPRAN HYDROCHLORIDE?

MILNACIPRAN HYDROCHLORIDE is formulated as: TABLET.

FDA Approves MILNACIPRAN HYDROCHLORIDE — ORIG Submission by STRIDES PHARMA, Not disclosed in the FDA record.

Here's the summary: STRIDES PHARMA received anda approval for MILNACIPRAN HYDROCHLORIDE (unspecified) on 2026-09-15. Application number ANDA207399, 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.

Key facts

Sponsor	STRIDES PHARMA
Brand name	MILNACIPRAN HYDROCHLORIDE
Generic name	unspecified
Dosage form	TABLET
Application number	ANDA207399
Submission number	1
Submission type	ORIG
Review priority	STANDARD
Status date	Not disclosed in the FDA record.

What was approved

FDA's record shows STRIDES PHARMA as the sponsor of MILNACIPRAN HYDROCHLORIDE, 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 ANDA207399, with a submission status date of 20260915. 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.

STRIDES PHARMA’s FDA history

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

Frequently asked questions

What is the FDA application number for this submission?: FDA application number ANDA207399, submission 1.
What review priority did FDA assign?: FDA designated this submission as: STANDARD.
What dosage form is MILNACIPRAN HYDROCHLORIDE?: MILNACIPRAN HYDROCHLORIDE is formulated as: TABLET.
What did FDA approve?: FDA's record shows anda approval for MILNACIPRAN HYDROCHLORIDE (unspecified), dosage form TABLET, sponsored by STRIDES PHARMA, under application number ANDA207399. 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.

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Full FDA history for STRIDES 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 Approves MILNACIPRAN HYDROCHLORIDE — ORIG Submission by STRIDES PHARMA, Not disclosed in the FDA record.. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/approval/strides-pharma-anda207399-2026-09-15

MLA

"FDA Approves MILNACIPRAN HYDROCHLORIDE — ORIG Submission by STRIDES PHARMA, Not disclosed in the FDA record.." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/approval/strides-pharma-anda207399-2026-09-15.

Chicago

Argus HQ Research. "FDA Approves MILNACIPRAN HYDROCHLORIDE — ORIG Submission by STRIDES PHARMA, Not disclosed in the FDA record.." Digital Empire Holdings LLC. Accessed September 23, 2026. https://argushq.ai/approval/strides-pharma-anda207399-2026-09-15.

BibTeX

@misc{argushq_argushq_ai_approval_strides_pharma_anda207399_2026_09_15_2026,
  title = {FDA Approves MILNACIPRAN HYDROCHLORIDE — ORIG Submission by STRIDES PHARMA, Not disclosed in the FDA record.},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/approval/strides-pharma-anda207399-2026-09-15},
  note = {Accessed: September 23, 2026}
}

Source: FDA.gov — Approvals ↗