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vancomycin hydrochloride · Mylan Labs Ltd · NDA 209481, 210274

Vancomycin Hydrochloride

Earliest generic entry, as listed · earliest of 12 marketed strengths
Open now

No unexpired patents or exclusivities are listed for this product.

Listed patents · 0 unexpired

No unexpired patents listed.

Exclusivities · 0 unexpired

No unexpired exclusivities listed.

Paragraph IV certifications · 0

No Paragraph IV certification listed by FDA for this drug.

The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.

Event history

  • Generic approved · ANDA 215324, Steriscience · 209481-001Approved 2 Oct 2025Detected 25 Oct 2026Historical import

Products covered · 13

NDA · productFormStrengthListed expiry
209481 · 001 · RLD · discontinuedpowder, intravenousEQ 250MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**open
209481 · 002 · RLDpowder, intravenousEQ 750MG BASE/VIALopen
209481 · 003 · RLDpowder, intravenousEQ 1.25GM BASE/VIALopen
209481 · 004 · RLDpowder, intravenousEQ 1.5GM BASE/VIALopen
209481 · 005 · RLDpowder, intravenousEQ 1.75GM BASE/VIALopen
209481 · 006 · RLDpowder, intravenousEQ 2GM BASE/VIALopen
210274 · 001 · RLDpowder, intravenous, oralEQ 500MG BASE/VIALopen
210274 · 002 · RLDpowder, intravenous, oralEQ 1GM BASE/VIALopen
210274 · 003 · RLDpowder, intravenous, oralEQ 5GM BASE/VIALopen
210274 · 004 · RLDpowder, intravenous, oralEQ 10GM BASE/VIALopen
210274 · 005 · RLDpowder, intravenous, oralEQ 750MG BASE/VIALopen
210274 · 006 · RLDpowder, intravenous, oralEQ 1.25GM BASE/VIALopen
210274 · 007 · RLDpowder, intravenous, oralEQ 1.5MG BASE/VIALopen