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FDA Orange Book · active-ingredient family

Gentamicin sulfate

Gentamicin sulfate is approved as 3 brand and 57 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:GARAMYCIN · NDA 050505

3

Brand (NDA)

57

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · cream, injectable, ointment, solution/drops

ProductApplicantApplicationTEApproved
GARAMYCINRLDSCHERINGNDA 050505—Approved Prior to Jan 1, 1982
GARAMYCINRLDSCHERINGNDA 050039—Approved Prior to Jan 1, 1982
GARAMYCINSCHERINGNDA 050425—Approved Prior to Jan 1, 1982

Generic (ANDA) products (57)

ProductApplicantApplicationTEApproved
GENTAMICIN SULFATEEUGIA PHARMAANDA 215236—Jan 08, 2024
GENTAMICIN SULFATEEUGIA PHARMAANDA 215237APJan 08, 2024
GENTAMICIN SULFATEENCUBEANDA 209233—Dec 31, 2018
GENTAMICIN SULFATEFERA PHARMS LLCANDA 065024—Jul 30, 2004
GENTAMICIN SULFATEPADAGIS USANDA 065121—Jan 30, 2004
GENTAKPHARMOBEDIENTANDA 064163—Oct 12, 2001
GENTAMICIN SULFATESCIEGEN PHARMSANDA 064093—Aug 31, 1995
GENTAMICIN SULFATEBAUSCH AND LOMB INCANDA 064048ATMay 11, 1994
GENTAMICIN SULFATECOSETTE PHARMS NCANDA 064056ATApr 29, 1994
GENTAMICIN SULFATECOSETTE PHARMS NCANDA 064054ATApr 29, 1994
GENTAMICIN SULFATETEVA PARENTERALANDA 063149—Nov 21, 1991
GENTAMICIN SULFATETEVA PARENTERALANDA 063106—Nov 21, 1991
GENTAMICIN SULFATEPACOANDA 062932—Nov 07, 1988
GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER×14B BRAUNANDA 062814—Aug 28, 1987
GENTAMICIN SULFATEEPIC PHARMA LLCANDA 062635—Jan 08, 1987
GENTAMICIN SULFATEHOSPIRAANDA 062612—Feb 20, 1986
GENTAMICIN SULFATE×2FRESENIUS KABI USAANDA 062366APFeb 06, 1986
GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER×10HOSPIRAANDA 062588—Jan 06, 1986
GENTAMICIN SULFATEALCON PHARMS LTDANDA 062523—Nov 25, 1985
GENTAFAIRPHARMAFAIRANDA 062493—Aug 28, 1985
GENTAMICIN SULFATE×2SOLOPAKANDA 062507—Jun 06, 1985
GENTAMICIN SULFATEPHARMADERMANDA 062534—Oct 10, 1984
GENOPTICALLERGANANDA 062452—Oct 10, 1984
GENTAMICIN SULFATEFOUGERA PHARMS INCANDA 062533ATOct 05, 1984
GENTACIDINNOVARTISANDA 062501—Jul 26, 1984
GENTAMICIN SULFATEFOUGERA PHARMS INCANDA 062531—Jul 05, 1984
GENTAMICIN SULFATEPHARMADERMANDA 062530—Jul 05, 1984
GENTACIDINNOVARTISANDA 062480—Mar 30, 1984
GENTAMICIN SULFATEALPHARMA US PHARMSANDA 062496—Mar 14, 1984
GENTAMICIN SULFATESUN PHARMA CANADAANDA 062477—Dec 23, 1983
GENTAMICIN SULFATEALPHARMA US PHARMSANDA 062471—Sep 27, 1983
GENTAFAIRPHARMAFAIRANDA 062458—Sep 01, 1983
GENTAMICIN SULFATE×2HOSPIRAANDA 062420APAug 15, 1983
GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER×10HOSPIRAANDA 062414—Aug 15, 1983
GENTAMICIN SULFATE×10ABBOTTANDA 062413—Aug 11, 1983
GENTAMICIN SULFATESUN PHARMA CANADAANDA 062427—May 26, 1983
GENTAFAIRPHARMAFAIRANDA 062443—May 26, 1983
GENTAFAIRPHARMAFAIRANDA 062444—May 26, 1983
GENTAFAIRPHARMAFAIRANDA 062440—May 03, 1983
GENTAMICIN SULFATEPHARM SPECANDA 062340—Mar 28, 1983
GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER×10BAXTER HLTHCAREANDA 062373—Sep 07, 1982
GENTAMICIN×3INTL MEDICATIONANDA 062325—Jun 23, 1982
GENTAMICIN SULFATEKALAPHARMANDA 062354—Apr 05, 1982
GENTAMICIN SULFATE×2FRESENIUS KABI USAANDA 062356—Mar 04, 1982
GENTAMICIN SULFATEPADAGIS USANDA 062351ATFeb 18, 1982
GARAMYCINSCHERINGANDA 060462—Approved Prior to Jan 1, 1982
GENTAMICIN SULFATEPADAGIS USANDA 062307ATApproved Prior to Jan 1, 1982
APOGEN×2KING PHARMSANDA 062289—Approved Prior to Jan 1, 1982
BRISTAGENBRISTOLANDA 062288—Approved Prior to Jan 1, 1982
GARAMYCIN×2SCHERINGANDA 061716—Approved Prior to Jan 1, 1982
GARAMYCINSCHERINGANDA 061739—Approved Prior to Jan 1, 1982
GENTAMICIN SULFATE×2HIKMAANDA 062251APApproved Prior to Jan 1, 1982
GENTAMICIN SULFATE×2WATSON LABSANDA 062318—Approved Prior to Jan 1, 1982
GENTAMICIN SULFATE×2WYETH AYERSTANDA 062264—Approved Prior to Jan 1, 1982
U-GENCIN×2PHARMACIA AND UPJOHNANDA 062248—Approved Prior to Jan 1, 1982
GARAMYCINSCHERINGANDA 060463—Approved Prior to Jan 1, 1982
GENTAMICIN SULFATESANDOZANDA 062196ATApproved 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.

Gentamicin sulfate — frequently asked questions

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

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