Assyro AI

FDA Orange Book · active-ingredient family

Kanamycin sulfate

Kanamycin sulfate is approved in 20 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

0

Brand (NDA)

20

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Generic (ANDA) products (20)

ProductApplicantApplicationTEApproved
KANAMYCIN SULFATE×2FRESENIUS KABI USAANDA 065111—Dec 17, 2002
KANAMYCIN SULFATELOCHANDA 063025—Jul 31, 1992
KANAMYCIN SULFATELOCHANDA 063021—Jul 31, 1992
KANAMYCIN SULFATELOCHANDA 063022—Jul 31, 1992
KANAMYCIN SULFATEWARNER CHILCOTTANDA 063092—Oct 11, 1989
KANAMYCIN SULFATEPHARMAFAIRANDA 062669—May 07, 1987
KANAMYCIN SULFATEPHARMAFAIRANDA 062668—May 07, 1987
KANAMYCIN SULFATEPHARMAFAIRANDA 062672—May 07, 1987
KANTREXAPOTHECONANDA 062726—Mar 06, 1987
KANAMYCIN SULFATE×3SOLOPAKANDA 062605—Feb 26, 1986
KANAMYCIN SULFATEWATSON LABSANDA 062520—May 09, 1985
KANTREX×3APOTHECONANDA 062564—Sep 21, 1984
KANAMYCIN SULFATE×3ABRAXIS PHARMANDA 062504—Apr 05, 1984
KANAMYCIN SULFATE×2INTL MEDICATIONANDA 062466—Sep 30, 1983
KANTREXAPOTHECONANDA 060516—Approved Prior to Jan 1, 1982
KANTREXAPOTHECONANDA 061911—Approved Prior to Jan 1, 1982
KANAMYCIN×3HIKMAANDA 062324—Approved Prior to Jan 1, 1982
KANTREX×3APOTHECONANDA 061655—Approved Prior to Jan 1, 1982
KANTREX×3APOTHECONANDA 061901—Approved Prior to Jan 1, 1982
KLEBCIL×3KING PHARMSANDA 062170—Approved Prior to Jan 1, 1982

Listed patents

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.

Kanamycin sulfate — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Agent CTA Background

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