FDA Orange Book · active-ingredient family
Daunorubicin hydrochloride
Daunorubicin hydrochloride: 2 brands, 8 generics; first approved Feb 03, 1995; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 8 ANDA applications approved.
Brands (NDA)
2
Generics (ANDA)
8
Listed patents
0
Presentations
11
Brand (NDA) products
Originator applications
- DAUNORUBICIN HYDROCHLORIDERLDRSHIKMANDA 0507311998
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5MG BASE/ML INJECTABLE INJECTION Rx AP - WYETH AYERSTNDA 050484—
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE/VIAL INJECTABLE INJECTION Discontinued —
Generic (ANDA) products (8)
Abbreviated applications
- DAUNORUBICIN HYDROCHLORIDEHISUN PHARM HANGZHOUANDA 2061952019
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE/VIAL INJECTABLE INJECTION Discontinued — - DAUNORUBICIN HYDROCHLORIDEHISUN PHARM HANGZHOUANDA 2087592019
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5MG BASE/ML INJECTABLE INJECTION Rx AP - DAUNORUBICIN HYDROCHLORIDEFRESENIUS KABI USAANDA 0650342001
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5MG BASE/VIAL INJECTABLE INJECTION Discontinued — - DAUNORUBICIN HYDROCHLORIDEMEITHEALANDA 0650352000
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5MG BASE/ML INJECTABLE INJECTION Rx AP - DAUNORUBICIN HYDROCHLORIDEFRESENIUS KABI USAANDA 0650001999
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE/VIAL INJECTABLE INJECTION Rx AP - DAUNORUBICIN HYDROCHLORIDETEVA PARENTERALANDA 06421219982 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE/VIAL INJECTABLE INJECTION Discontinued — EQ 50MG BASE/VIAL INJECTABLE INJECTION Discontinued — - HIKMAANDA 0641031995
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE/VIAL INJECTABLE INJECTION Rx AP - SANOFI AVENTIS USANDA 061876—
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG 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
32 yr ago
Most recent approval
7 yr 5 mo ago
Approvals span 1995–2019 across 10 FDA applications.
Brand (NDA) 220%
Generic (ANDA) 880%
Daunorubicin hydrochloride: 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.
