Key facts
| Sponsor | SABA ILAC SANAYIVE |
|---|---|
| Brand name | BRIMONIDINE TARTRATE AND TIMOLOL MALEATE |
| Generic name | unspecified |
| Dosage form | SOLUTION/DROPS |
| Application number | ANDA217934 |
| Submission number | 1 |
| Submission type | ORIG |
| Review priority | STANDARD |
| Status date | Not disclosed in the FDA record. |
What was approved
FDA's record shows SABA ILAC SANAYIVE as the sponsor of BRIMONIDINE TARTRATE AND TIMOLOL MALEATE, with the generic name recorded as Not disclosed in the FDA record. 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 ANDA217934, with a submission status date of 20260701. 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.
Regulatory context
This application was reviewed under FDA's standard review pathway, which typically targets a 10-month review goal measured from submission. 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.
SABA ILAC SANAYIVE’s FDA history
Argus HQ has recorded 1 total FDA action tied to SABA ILAC SANAYIVE: 0 warning letters, 0 recalls, 1 approval record, and 0 Form 483 inspection citations.
Frequently asked questions
- What did FDA approve?
- FDA's record shows ANDA approval for BRIMONIDINE TARTRATE AND TIMOLOL MALEATE (Not disclosed in the FDA record.), dosage form SOLUTION/DROPS, sponsored by SABA ILAC SANAYIVE, under application number ANDA217934. FDA publishes approval and submission records so physicians, competitors, and investors can track which sponsors and products have cleared a given regulatory pathway.
- 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 20260701. 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.
- Does SABA ILAC SANAYIVE have other FDA approval records?
- This is the only FDA action Argus HQ has on file for SABA ILAC SANAYIVE so far. Argus ingests new FDA records daily.
Track this company's next FDA filing before it moves the stock.
Free weekly briefing on approvals, warning letters, and inspections.
Related enforcement actions
Full FDA history for SABA ILAC SANAYIVECompiled 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.
Argus HQ Research (2026). Approval Record: BRIMONIDINE TARTRATE AND TIMOLOL MALEATE — SABA ILAC SANAYIVE, ORIG (Not disclosed in the FDA record.). Digital Empire LLC. Retrieved from https://argushq.ai/approval/fda-approval-saba-ilac-sanayive-anda217934-1
"Approval Record: BRIMONIDINE TARTRATE AND TIMOLOL MALEATE — SABA ILAC SANAYIVE, ORIG (Not disclosed in the FDA record.)." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/approval/fda-approval-saba-ilac-sanayive-anda217934-1.
Argus HQ Research. "Approval Record: BRIMONIDINE TARTRATE AND TIMOLOL MALEATE — SABA ILAC SANAYIVE, ORIG (Not disclosed in the FDA record.)." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/approval/fda-approval-saba-ilac-sanayive-anda217934-1.
@misc{argushq_argushq_ai_approval_fda_approval_saba_ilac_sanayive_anda217934_1_2026,
title = {Approval Record: BRIMONIDINE TARTRATE AND TIMOLOL MALEATE — SABA ILAC SANAYIVE, ORIG (Not disclosed in the FDA record.)},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/approval/fda-approval-saba-ilac-sanayive-anda217934-1},
note = {Accessed: July 13, 2026}
}Source: FDA.gov — Approvals ↗