Bacitracin zinc; neomycin sulfate; polymyxin b sulfate
Bacitracin zinc; neomycin sulfate; polymyxin b sulfate: 1 brand, 7 generics; first approved Sep 09, 1982; generic available.
Generic available: 7 ANDA applications approved.
Brand (NDA) products
- LUMI-SPORYNRLDCASPER PHARMA LLCNDA 050417—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for s or e reasons** OINTMENT OPHTHALMIC Rx AT
Generic (ANDA) products (7)
- SCIEGEN PHARMSANDA 0650882004
Approved strengths under this FDA application. Strength Dosage form Route Status TE 400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM OINTMENT OPHTHALMIC Discontinued — - BAUSCH AND LOMB INCANDA 0640641995
Approved strengths under this FDA application. Strength Dosage form Route Status TE 400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM OINTMENT OPHTHALMIC Rx AT - BACITRACIN ZINC-NEOMYCIN SULFATE-POLYMYXIN B SULFATENASKAANDA 0628331987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 400 UNITS/GM;EQ 3.5MG BASE/GM;5,000 UNITS/GM OINTMENT TOPICAL Discontinued — - BACITRACIN ZINC-NEOMYCIN SULFATE-POLYMYXIN B SULFATEPHARMAFAIRANDA 0623861982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM OINTMENT OPHTHALMIC Discontinued — - PHARMADERMANDA 062167—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 400 UNITS/GM;EQ 3.5MG BASE/GM;5,000 UNITS/GM OINTMENT OPHTHALMIC Discontinued — - DOW PHARMANDA 060647—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM OINTMENT OPHTHALMIC Discontinued — - PADAGIS USANDA 060764—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM OINTMENT OPHTHALMIC Discontinued —
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Approval history
Approvals span 1982–2004 across 8 FDA applications.
Bacitracin zinc; neomycin sulfate; polymyxin b sulfate: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
