Bacitracin zinc; hydrocortisone; neomycin sulfate; polymyxin b sulfate
Bacitracin zinc; hydrocortisone; neomycin sulfate; polymyxin b sulfate: 2 brands, 4 generics; first approved Jul 02, 1982; generic available.
Generic available: 4 ANDA applications approved.
Brand (NDA) products
- CORTISPORINRLDMONARCH PHARMSNDA 0501681984
Approved strengths under this FDA application. Strength Dosage form Route Status TE 400 UNITS/GM;1%;EQ 3.5MG BASE/GM;5,000 UNITS/GM OINTMENT TOPICAL Discontinued — - CORTISPORINRLDCASPER PHARMA LLCNDA 050416—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM OINTMENT OPHTHALMIC Discontinued —
Generic (ANDA) products (4)
- SCIEGEN PHARMSANDA 0652132012
Approved strengths under this FDA application. Strength Dosage form Route Status TE 400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM OINTMENT OPHTHALMIC Discontinued — - BAUSCH AND LOMB INCANDA 0640681995
Approved strengths under this FDA application. Strength Dosage form Route Status TE 400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM OINTMENT OPHTHALMIC Rx — - PHARMAFAIRANDA 0623811985
Approved strengths under this FDA application. Strength Dosage form Route Status TE 400 UNITS/GM;1%;EQ 3.5MG BASE/GM;5,000 UNITS/GM OINTMENT TOPICAL Discontinued — - PHARMAFAIRANDA 0623891982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 400 UNITS/GM;1%;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 1982–2012 across 6 FDA applications.
Bacitracin zinc; hydrocortisone; 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.
