Bacitracin zinc; polymyxin b sulfate
Bacitracin zinc; polymyxin b sulfate: 1 brand, 6 generics; first approved Apr 08, 1983; generic available.
Generic available: 6 ANDA applications approved.
Brand (NDA) products
- GLAXOSMITHKLINENDA 0501671985
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10,000 UNITS/GM;2,000,000 UNITS/GM AEROSOL TOPICAL Discontinued —
Generic (ANDA) products (6)
- PADAGIS USANDA 0650222002
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500 UNITS/GM;10,000 UNITS/GM OINTMENT OPHTHALMIC Discontinued — - SCIEGEN PHARMSANDA 0640281995
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500 UNITS/GM;10,000 UNITS/GM OINTMENT OPHTHALMIC Discontinued — - BAUSCH AND LOMB INCANDA 0640461995
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500 UNITS/GM;10,000 UNITS/GM OINTMENT OPHTHALMIC Rx — - BACITRACIN ZINC-POLYMYXIN B SULFATENASKAANDA 0628491987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500 UNITS/GM;10,000 UNITS/GM OINTMENT TOPICAL Discontinued — - PHARMAFAIRANDA 0624301983
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500 UNITS/GM;10,000 UNITS/GM OINTMENT OPHTHALMIC Discontinued — - MONARCH PHARMSANDA 061229—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500 UNITS/GM;10,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for s or e reasons** OINTMENT OPHTHALMIC Discontinued —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 1983–2002 across 7 FDA applications.
Bacitracin zinc; 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.
