FDA Orange Book · active-ingredient family
Bacitracin
Bacitracin: 0 brands, 10 generics; first approved Jul 27, 1983; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 10 ANDA applications approved.
Brands (NDA)
0
Generics (ANDA)
10
Listed patents
0
Presentations
10
Generic (ANDA) products (10)
Abbreviated applications
- BACITRACINNASKAANDA 0628571987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500 UNITS/GM OINTMENT TOPICAL Discontinued — - BACITRACINCOMBEANDA 0627991987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500 UNITS/GM OINTMENT TOPICAL Discontinued — - BACITRACINPHARMAFAIRANDA 0624531984
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500 UNITS/GM OINTMENT OPHTHALMIC Discontinued — - BACITRACINPADDOCK LLCANDA 0624561983
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5,000,000 UNITS/BOT POWDER FOR RX COMPOUNDING Discontinued — - PHARMACIA AND UPJOHNANDA 060734—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500 UNITS/GM OINTMENT OPHTHALMIC Discontinued — - BACITRACINLILLYANDA 060687—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500 UNITS/GM OINTMENT OPHTHALMIC Discontinued — - BACITRACINPADAGIS USANDA 061212—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500 UNITS/GM OINTMENT OPHTHALMIC Discontinued — - BACITRACINPHARMADERMANDA 062158—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500 UNITS/GM OINTMENT OPHTHALMIC Discontinued — - X GEN PHARMSANDA 061580—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5,000,000 UNITS/BOT POWDER FOR RX COMPOUNDING Discontinued — - BACITRACINAPOTHEKERNESANDA 061699—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5,000,000 UNITS/BOT POWDER FOR RX COMPOUNDING 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.
Approval history
FDA approval span
First approval
43 yr 8 mo ago
Most recent approval
39 yr 4 mo ago
Approvals span 1983–1987 across 10 FDA applications.
Brand (NDA) 00%
Generic (ANDA) 10100%
Bacitracin: 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.
