Does ORBICULAR PHARM TECH have other FDA approval records?

This is the only FDA action Argus HQ has on file for ORBICULAR PHARM TECH so far. Argus ingests new FDA records daily.

What is the FDA application number for this submission?

FDA application number ANDA220938, submission 1.

What review priority did FDA assign?

FDA designated this submission as: STANDARD.

What dosage form is NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE?

NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE is formulated as: SOLUTION/DROPS.

ORBICULAR PHARM TECH — FDA ORIG Approval for NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (Not disclosed in the FDA record.)

Key facts

Sponsor	ORBICULAR PHARM TECH
Brand name	NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE
Generic name	unspecified
Dosage form	SOLUTION/DROPS
Application number	ANDA220938
Submission number	1
Submission type	ORIG
Review priority	STANDARD
Status date	Not disclosed in the FDA record.

The short version: ORBICULAR PHARM TECH received anda approval for NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (unspecified) on 2026-08-27. Application number ANDA220938, submission type ORIG (submission 1). Dosage form: SOLUTION/DROPS. 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 ORBICULAR PHARM TECH as the sponsor of NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE, with the generic name recorded as unspecified and dosage form SOLUTION/DROPS. 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 ANDA220938, with a submission status date of 20260827. 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.

ORBICULAR PHARM TECH’s FDA history

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

Frequently asked questions

Does ORBICULAR PHARM TECH have other FDA approval records?: This is the only FDA action Argus HQ has on file for ORBICULAR PHARM TECH so far. Argus ingests new FDA records daily.
What is the FDA application number for this submission?: FDA application number ANDA220938, submission 1.
What review priority did FDA assign?: FDA designated this submission as: STANDARD.
What dosage form is NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE?: NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE is formulated as: SOLUTION/DROPS.

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Full FDA history for ORBICULAR PHARM TECH

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). ORBICULAR PHARM TECH — FDA ORIG Approval for NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (Not disclosed in the FDA record.). Digital Empire Holdings LLC. Retrieved from https://argushq.ai/approval/orbicular-pharm-tech-anda220938-2026-08-27

MLA

"ORBICULAR PHARM TECH — FDA ORIG Approval for NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (Not disclosed in the FDA record.)." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/approval/orbicular-pharm-tech-anda220938-2026-08-27.

Chicago

Argus HQ Research. "ORBICULAR PHARM TECH — FDA ORIG Approval for NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (Not disclosed in the FDA record.)." Digital Empire Holdings LLC. Accessed September 5, 2026. https://argushq.ai/approval/orbicular-pharm-tech-anda220938-2026-08-27.

BibTeX

@misc{argushq_argushq_ai_approval_orbicular_pharm_tech_anda220938_2026_08_27_2026,
  title = {ORBICULAR PHARM TECH — FDA ORIG Approval for NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE (Not disclosed in the FDA record.)},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/approval/orbicular-pharm-tech-anda220938-2026-08-27},
  note = {Accessed: September 5, 2026}
}

Source: FDA.gov — Approvals ↗