FDA Orange Book · active-ingredient family
Carmustine
Carmustine: 3 brands, 11 generics; first approved Sep 23, 1996; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 11 ANDA applications approved.
Brands (NDA)
3
Generics (ANDA)
11
Listed patents
0
Presentations
15
Brand (NDA) products
Originator applications
- CARMUSTINERLDACCORD HLTHCARENDA 21500020222 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/VIAL POWDER INTRAVENOUS Discontinued — 300MG/VIAL POWDER INTRAVENOUS Discontinued — - AZURITYNDA 0206371996
Approved strengths under this FDA application. Strength Dosage form Route Status TE 7.7MG IMPLANT INTRACRANIAL Rx — - AVET LIFESCIENCESNDA 017422—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/VIAL INJECTABLE INJECTION Rx AP
Generic (ANDA) products (11)
Abbreviated applications
- CARMUSTINEALEMBICANDA 2157302023
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/VIAL INJECTABLE INJECTION Rx AP - CARMUSTINEMSNANDA 2148142023
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/VIAL INJECTABLE INJECTION Rx AP - CARMUSTINEPHARMOBEDIENTANDA 2153682023
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/VIAL INJECTABLE INJECTION Discontinued — - CARMUSTINEACCORD HLTHCAREANDA 2141172022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/VIAL INJECTABLE INJECTION Discontinued — - CARMUSTINEINGENUS PHARMS LLCANDA 2110112022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/VIAL INJECTABLE INJECTION Discontinued — - CARMUSTINEMEITHEALANDA 2134602021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/VIAL INJECTABLE INJECTION Rx AP - CARMUSTINEHENGRUI PHARMAANDA 2112022021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/VIAL INJECTABLE INJECTION Discontinued — - CARMUSTINEDR REDDYSANDA 2132072020
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/VIAL INJECTABLE INJECTION Rx AP - CARMUSTINEPENN LIFEANDA 2092782019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/VIAL INJECTABLE INJECTION Rx AP - CARMUSTINEAMNEALANDA 2112292018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/VIAL INJECTABLE INJECTION Rx AP - CARMUSTINENAVINTA LLCANDA 2101792018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/VIAL INJECTABLE INJECTION Rx AP
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
30 yr 4 mo ago
Most recent approval
2 yr 10 mo ago
Approvals span 1996–2023 across 14 FDA applications.
Brand (NDA) 321%
Generic (ANDA) 1179%
Carmustine: 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.
