FDA Orange Book · active-ingredient family
Bacitracin; hydrocortisone acetate; neomycin sulfate; polymyxin b sulfate
Bacitracin; hydrocortisone acetate; neomycin sulfate; polymyxin b sulfate: 0 brands, 1 generic; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 1 ANDA application approved.
Brands (NDA)
0
Generics (ANDA)
1
Listed patents
0
Presentations
1
Generic (ANDA) products (1)
Abbreviated applications
- ALTANAANDA 060731—
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
Orange Book patent file
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.
Bacitracin; hydrocortisone acetate; 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.
