FDA Orange Book · active-ingredient family
Kanamycin sulfate
Kanamycin sulfate: 0 brands, 20 generics; first approved Sep 30, 1983; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 20 ANDA applications approved.
Brands (NDA)
0
Generics (ANDA)
20
Listed patents
0
Presentations
36
Generic (ANDA) products (20)
Abbreviated applications
- KANAMYCIN SULFATEFRESENIUS KABI USAANDA 06511120022 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/2ML INJECTABLE INJECTION Discontinued — EQ 1GM BASE/3ML INJECTABLE INJECTION Discontinued — - KANAMYCIN SULFATELOCHANDA 0630251992
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1GM BASE/3ML INJECTABLE INJECTION Discontinued — - KANAMYCIN SULFATELOCHANDA 0630211992
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 75MG BASE/2ML INJECTABLE INJECTION Discontinued — - KANAMYCIN SULFATELOCHANDA 0630221992
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/2ML INJECTABLE INJECTION Discontinued — - KANAMYCIN SULFATEWARNER CHILCOTTANDA 0630921989
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1GM BASE/3ML INJECTABLE INJECTION Discontinued — - KANAMYCIN SULFATEPHARMAFAIRANDA 0626691987
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1GM BASE/3ML INJECTABLE INJECTION Discontinued — - KANAMYCIN SULFATEPHARMAFAIRANDA 0626681987
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 75MG BASE/2ML INJECTABLE INJECTION Discontinued — - KANAMYCIN SULFATEPHARMAFAIRANDA 0626721987
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/2ML INJECTABLE INJECTION Discontinued — - APOTHECONANDA 0627261987
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE CAPSULE ORAL Discontinued — - KANAMYCIN SULFATESOLOPAKANDA 06260519863 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/2ML INJECTABLE INJECTION Discontinued — EQ 1GM BASE/3ML INJECTABLE INJECTION Discontinued — EQ 75MG BASE/2ML INJECTABLE INJECTION Discontinued — - KANAMYCIN SULFATEWATSON LABSANDA 0625201985
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1GM BASE/3ML INJECTABLE INJECTION Discontinued — - APOTHECONANDA 06256419843 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 75MG BASE/2ML INJECTABLE INJECTION Discontinued — EQ 500MG BASE/2ML INJECTABLE INJECTION Discontinued — EQ 1GM BASE/3ML INJECTABLE INJECTION Discontinued — - KANAMYCIN SULFATEABRAXIS PHARMANDA 06250419843 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 75MG BASE/2ML INJECTABLE INJECTION Discontinued — EQ 500MG BASE/2ML INJECTABLE INJECTION Discontinued — EQ 1GM BASE/3ML INJECTABLE INJECTION Discontinued — - KANAMYCIN SULFATEINTL MEDICATIONANDA 06246619832 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/2ML INJECTABLE INJECTION Discontinued — EQ 1GM BASE/3ML INJECTABLE INJECTION Discontinued — - APOTHECONANDA 060516—
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE CAPSULE ORAL Discontinued — - APOTHECONANDA 061911—
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE CAPSULE ORAL Discontinued — - HIKMAANDA 062324—3 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 75MG BASE/2ML INJECTABLE INJECTION Discontinued — EQ 500MG BASE/2ML INJECTABLE INJECTION Discontinued — EQ 1GM BASE/3ML INJECTABLE INJECTION Discontinued — - APOTHECONANDA 061655—3 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/2ML INJECTABLE INJECTION Discontinued — EQ 1GM BASE/3ML INJECTABLE INJECTION Discontinued — EQ 75MG BASE/2ML INJECTABLE INJECTION Discontinued — - APOTHECONANDA 061901—3 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/2ML INJECTABLE INJECTION Discontinued — EQ 1GM BASE/3ML INJECTABLE INJECTION Discontinued — EQ 75MG BASE/2ML INJECTABLE INJECTION Discontinued — - KING PHARMSANDA 062170—3 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 75MG BASE/2ML INJECTABLE INJECTION Discontinued — EQ 500MG BASE/2ML INJECTABLE INJECTION Discontinued — EQ 1GM BASE/3ML 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
43 yr 8 mo ago
Most recent approval
24 yr 2 mo ago
Approvals span 1983–2002 across 20 FDA applications.
Brand (NDA) 00%
Generic (ANDA) 20100%
Kanamycin 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.
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