FDA Orange Book · active-ingredient family
Bleomycin sulfate
Bleomycin sulfate: 1 brand, 8 generics; first approved Sep 07, 1995; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 8 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
8
Listed patents
0
Presentations
16
Brand (NDA) products
Originator applications
- BLENOXANERLDBRISTOL MYERS SQUIBBNDA 050443—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 15 UNITS BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 30 UNITS BASE/VIAL INJECTABLE INJECTION Discontinued —
Generic (ANDA) products (8)
Abbreviated applications
- BLEOMYCIN SULFATECIPLAANDA 2094392019
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 15 UNITS BASE/VIAL INJECTABLE INJECTION Discontinued — - BLEOMYCIN SULFATEMEITHEALANDA 20503020182 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 15 UNITS BASE/VIAL INJECTABLE INJECTION Rx AP EQ 30 UNITS BASE/VIAL INJECTABLE INJECTION Rx AP - BLEOMYCIN SULFATERSFRESENIUS KABI USAANDA 06518520082 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 15 UNITS BASE/VIAL INJECTABLE INJECTION Rx AP EQ 30 UNITS BASE/VIAL INJECTABLE INJECTION Rx AP - BLEOMYCIN SULFATEPHARMACHEMIE BVANDA 0652012007
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 15 UNITS BASE/VIAL INJECTABLE INJECTION Discontinued — - BLEOMYCIN SULFATEHIKMAANDA 06504220012 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 30 UNITS BASE/VIAL INJECTABLE INJECTION Rx AP EQ 15 UNITS BASE/VIAL INJECTABLE INJECTION Rx AP - BLEOMYCIN SULFATETEVA PHARMS USAANDA 06503320002 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 15 UNITS BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 30 UNITS BASE/VIAL INJECTABLE INJECTION Discontinued — - BLEOMYCIN SULFATEHOSPIRAANDA 06503120002 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 15 UNITS BASE/VIAL INJECTABLE INJECTION Rx AP EQ 30 UNITS BASE/VIAL INJECTABLE INJECTION Rx AP - BLEOMYCIN SULFATETEVA PARENTERALANDA 06408419962 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 15 UNITS BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 30 UNITS BASE/VIAL INJECTABLE INJECTION 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
31 yr 5 mo ago
Most recent approval
7 yr 7 mo ago
Approvals span 1995–2019 across 9 FDA applications.
Brand (NDA) 111%
Generic (ANDA) 889%
Bleomycin 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.
