Is there a generic for Gentamicin sulfate?

Yes. The FDA Orange Book lists 57 approved generic (ANDA) applications for Gentamicin sulfate, referencing the brand GARAMYCIN. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Gentamicin sulfate?

GARAMYCIN (NDA 050505, SCHERING) is the reference-listed drug, the approved product a generic applicant must show its version is the same as.

What dosage forms of Gentamicin sulfate are approved?

Gentamicin sulfate is approved in the following dosage forms: cream, injectable, ointment, solution/drops.

FDA Orange Book · active-ingredient family

Gentamicin sulfate

Gentamicin sulfate: 3 brands, 57 generics; first approved Feb 18, 1982; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available: 57 ANDA applications approved.

Brands (NDA)

Generics (ANDA)

Listed patents

Presentations

121

Brand (NDA) products

Originator applications

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GARAMYCINRLD
SCHERINGNDA 050505-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 2MG BASE/ML INJECTABLE INTRATHECAL Discontinued -
GARAMYCINRLD
SCHERINGNDA 050039-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 0.3% BASE SOLUTION/DROPS OPHTHALMIC Discontinued -
GARAMYCIN
SCHERINGNDA 050425-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 0.3% BASE OINTMENT OPHTHALMIC Discontinued -

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 2MG BASE/ML	INJECTABLE	INTRATHECAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 0.3% BASE	SOLUTION/DROPS	OPHTHALMIC	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 0.3% BASE	OINTMENT	OPHTHALMIC	Discontinued	-

Generic (ANDA) products (57)

Abbreviated applications

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GENTAMICIN SULFATE
EUGIA PHARMAANDA 2152362024
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 10MG BASE/ML INJECTABLE INJECTION Discontinued -
GENTAMICIN SULFATE
EUGIA PHARMAANDA 2152372024
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 40MG BASE/ML INJECTABLE INJECTION Rx AP
GENTAMICIN SULFATE
ENCUBEANDA 2092332018
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 0.1% BASE OINTMENT TOPICAL Discontinued -
GENTAMICIN SULFATERS
FERA PHARMS LLCANDA 0650242004
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 0.3% BASE OINTMENT OPHTHALMIC Rx -
GENTAMICIN SULFATE
PADAGIS USANDA 0651212004
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 0.3% BASE SOLUTION/DROPS OPHTHALMIC Discontinued -
GENTAK
PHARMOBEDIENTANDA 0641632001
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 0.3% BASE SOLUTION/DROPS OPHTHALMIC Discontinued -
GENTAMICIN SULFATE
SCIEGEN PHARMSANDA 0640931995
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 0.3% BASE OINTMENT OPHTHALMIC Discontinued -
GENTAMICIN SULFATE
BAUSCH AND LOMB INCANDA 0640481994
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 0.3% BASE SOLUTION/DROPS OPHTHALMIC Rx AT
GENTAMICIN SULFATE
COSETTE PHARMS NCANDA 0640561994
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 0.1% BASE CREAM TOPICAL Rx AT
GENTAMICIN SULFATE
COSETTE PHARMS NCANDA 0640541994
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 0.1% BASE OINTMENT TOPICAL Rx AT
GENTAMICIN SULFATE
TEVA PARENTERALANDA 0631491991
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 10MG BASE/ML INJECTABLE INJECTION Discontinued -
GENTAMICIN SULFATE
TEVA PARENTERALANDA 0631061991
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 40MG BASE/ML INJECTABLE INJECTION Discontinued -
GENTAMICIN SULFATE
PACOANDA 0629321988
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 3MG BASE/ML SOLUTION/DROPS OPHTHALMIC Discontinued -

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 10MG BASE/ML	INJECTABLE	INJECTION	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 40MG BASE/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 0.1% BASE	OINTMENT	TOPICAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 0.3% BASE	OINTMENT	OPHTHALMIC	Rx	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 0.3% BASE	SOLUTION/DROPS	OPHTHALMIC	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 0.3% BASE	SOLUTION/DROPS	OPHTHALMIC	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 0.3% BASE	OINTMENT	OPHTHALMIC	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 0.3% BASE	SOLUTION/DROPS	OPHTHALMIC	Rx	AT

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 0.1% BASE	CREAM	TOPICAL	Rx	AT

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 0.1% BASE	OINTMENT	TOPICAL	Rx	AT

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 10MG BASE/ML	INJECTABLE	INJECTION	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 3MG BASE/ML	SOLUTION/DROPS	OPHTHALMIC	Discontinued	-

GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

B BRAUNANDA 062814198714 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 0.8MG BASE/ML	INJECTABLE	INJECTION	Discontinued	-
EQ 1.2MG BASE/ML	INJECTABLE	INJECTION	Discontinued	-
EQ 1.4MG BASE/ML	INJECTABLE	INJECTION	Discontinued	-
EQ 1.6MG BASE/ML	INJECTABLE	INJECTION	Discontinued	-
EQ 1.8MG BASE/ML	INJECTABLE	INJECTION	Discontinued	-
EQ 2MG BASE/ML	INJECTABLE	INJECTION	Discontinued	-
EQ 2.4MG BASE/ML	INJECTABLE	INJECTION	Discontinued	-
EQ 40MG BASE/100ML	INJECTABLE	INJECTION	Discontinued	-
EQ 60MG BASE/100ML	INJECTABLE	INJECTION	Discontinued	-
EQ 70MG BASE/100ML	INJECTABLE	INJECTION	Discontinued	-
EQ 80MG BASE/100ML	INJECTABLE	INJECTION	Discontinued	-
EQ 90MG BASE/100ML	INJECTABLE	INJECTION	Discontinued	-
EQ 100MG BASE/100ML	INJECTABLE	INJECTION	Discontinued	-
EQ 120MG BASE/100ML	INJECTABLE	INJECTION	Discontinued	-

GENTAMICIN SULFATE
EPIC PHARMA LLCANDA 0626351987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 0.3% BASE SOLUTION/DROPS OPHTHALMIC Discontinued -
GENTAMICIN SULFATE
HOSPIRAANDA 0626121986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 10MG BASE/ML INJECTABLE INJECTION Discontinued -
GENTAMICIN SULFATERS
FRESENIUS KABI USAANDA 06236619862 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 40MG BASE/ML INJECTABLE INJECTION Rx AP
EQ 10MG BASE/ML INJECTABLE INJECTION Rx AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 0.3% BASE	SOLUTION/DROPS	OPHTHALMIC	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 10MG BASE/ML	INJECTABLE	INJECTION	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 40MG BASE/ML	INJECTABLE	INJECTION	Rx	AP
EQ 10MG BASE/ML	INJECTABLE	INJECTION	Rx	AP

GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

HOSPIRAANDA 062588198610 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 1.2MG BASE/ML	INJECTABLE	INJECTION	Discontinued	-
EQ 1.4MG BASE/ML	INJECTABLE	INJECTION	Discontinued	-
EQ 1.6MG BASE/ML	INJECTABLE	INJECTION	Discontinued	-
EQ 1.8MG BASE/ML	INJECTABLE	INJECTION	Discontinued	-
EQ 2MG BASE/ML	INJECTABLE	INJECTION	Discontinued	-
EQ 60MG BASE/100ML	INJECTABLE	INJECTION	Discontinued	-
EQ 70MG BASE/100ML	INJECTABLE	INJECTION	Discontinued	-
EQ 80MG BASE/100ML	INJECTABLE	INJECTION	Discontinued	-
EQ 90MG BASE/100ML	INJECTABLE	INJECTION	Discontinued	-
EQ 100MG BASE/100ML	INJECTABLE	INJECTION	Discontinued	-

GENTAMICIN SULFATE
ALCON PHARMS LTDANDA 0625231985
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 0.3% BASE SOLUTION/DROPS OPHTHALMIC Discontinued -
GENTAFAIR
PHARMAFAIRANDA 0624931985
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 40MG BASE/ML INJECTABLE INJECTION Discontinued -
GENTAMICIN SULFATE
SOLOPAKANDA 06250719852 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 10MG BASE/ML INJECTABLE INJECTION Discontinued -
EQ 40MG BASE/ML INJECTABLE INJECTION Discontinued -
GENTAMICIN SULFATE
PHARMADERMANDA 0625341984
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 0.1% BASE OINTMENT TOPICAL Discontinued -
GENOPTIC
ALLERGANANDA 0624521984
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 0.3% BASE SOLUTION/DROPS OPHTHALMIC Discontinued -
GENTAMICIN SULFATE
FOUGERA PHARMS INCANDA 0625331984
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 0.1% BASE OINTMENT TOPICAL Rx AT
GENTACIDIN
NOVARTISANDA 0625011984
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 0.3% BASE OINTMENT OPHTHALMIC Discontinued -
GENTAMICIN SULFATE
FOUGERA PHARMS INCANDA 0625311984
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 0.1% BASE CREAM TOPICAL Discontinued -
GENTAMICIN SULFATE
PHARMADERMANDA 0625301984
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 1MG BASE/GM CREAM TOPICAL Discontinued -
GENTACIDIN
NOVARTISANDA 0624801984
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 0.3% BASE SOLUTION/DROPS OPHTHALMIC Discontinued -
GENTAMICIN SULFATE
ALPHARMA US PHARMSANDA 0624961984
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 0.1% BASE OINTMENT TOPICAL Discontinued -
GENTAMICIN SULFATE
SUN PHARMA CANADAANDA 0624771983
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 0.1% BASE OINTMENT TOPICAL Discontinued -
GENTAMICIN SULFATE
ALPHARMA US PHARMSANDA 0624711983
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 0.1% BASE CREAM TOPICAL Discontinued -
GENTAFAIR
PHARMAFAIRANDA 0624581983
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 0.1% BASE CREAM TOPICAL Discontinued -
GENTAMICIN SULFATE
HOSPIRAANDA 06242019832 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 10MG BASE/ML INJECTABLE INJECTION Rx AP
EQ 40MG BASE/ML INJECTABLE INJECTION Rx AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 0.3% BASE	SOLUTION/DROPS	OPHTHALMIC	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 10MG BASE/ML	INJECTABLE	INJECTION	Discontinued	-
EQ 40MG BASE/ML	INJECTABLE	INJECTION	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 0.1% BASE	OINTMENT	TOPICAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 0.3% BASE	SOLUTION/DROPS	OPHTHALMIC	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 0.1% BASE	OINTMENT	TOPICAL	Rx	AT

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 0.3% BASE	OINTMENT	OPHTHALMIC	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 0.1% BASE	CREAM	TOPICAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 1MG BASE/GM	CREAM	TOPICAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 0.3% BASE	SOLUTION/DROPS	OPHTHALMIC	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 0.1% BASE	OINTMENT	TOPICAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 0.1% BASE	OINTMENT	TOPICAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 0.1% BASE	CREAM	TOPICAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 0.1% BASE	CREAM	TOPICAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 10MG BASE/ML	INJECTABLE	INJECTION	Rx	AP
EQ 40MG BASE/ML	INJECTABLE	INJECTION	Rx	AP

GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

HOSPIRAANDA 062414198310 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 1.2MG BASE/ML	INJECTABLE	INJECTION	Discontinued	-
EQ 1.4MG BASE/ML	INJECTABLE	INJECTION	Discontinued	-
EQ 1.6MG BASE/ML	INJECTABLE	INJECTION	Discontinued	-
EQ 1.8MG BASE/ML	INJECTABLE	INJECTION	Discontinued	-
EQ 2MG BASE/ML	INJECTABLE	INJECTION	Discontinued	-
EQ 60MG BASE/100ML	INJECTABLE	INJECTION	Discontinued	-
EQ 70MG BASE/100ML	INJECTABLE	INJECTION	Discontinued	-
EQ 80MG BASE/100ML	INJECTABLE	INJECTION	Discontinued	-
EQ 90MG BASE/100ML	INJECTABLE	INJECTION	Discontinued	-
EQ 100MG BASE/100ML	INJECTABLE	INJECTION	Discontinued	-

GENTAMICIN SULFATE

ABBOTTANDA 062413198310 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 1.2MG BASE/ML	INJECTABLE	INJECTION	Discontinued	-
EQ 1.4MG BASE/ML	INJECTABLE	INJECTION	Discontinued	-
EQ 1.6MG BASE/ML	INJECTABLE	INJECTION	Discontinued	-
EQ 1.8MG BASE/ML	INJECTABLE	INJECTION	Discontinued	-
EQ 2MG BASE/ML	INJECTABLE	INJECTION	Discontinued	-
EQ 60MG BASE/100ML	INJECTABLE	INJECTION	Discontinued	-
EQ 70MG BASE/100ML	INJECTABLE	INJECTION	Discontinued	-
EQ 80MG BASE/100ML	INJECTABLE	INJECTION	Discontinued	-
EQ 90MG BASE/100ML	INJECTABLE	INJECTION	Discontinued	-
EQ 100MG BASE/100ML	INJECTABLE	INJECTION	Discontinued	-

GENTAMICIN SULFATE
SUN PHARMA CANADAANDA 0624271983
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 0.1% BASE CREAM TOPICAL Discontinued -
GENTAFAIR
PHARMAFAIRANDA 0624431983
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 3MG BASE/GM OINTMENT OPHTHALMIC Discontinued -
GENTAFAIR
PHARMAFAIRANDA 0624441983
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 0.1% BASE OINTMENT TOPICAL Discontinued -
GENTAFAIR
PHARMAFAIRANDA 0624401983
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 0.3% BASE SOLUTION/DROPS OPHTHALMIC Discontinued -
GENTAMICIN SULFATE
PHARM SPECANDA 0623401983
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 40MG BASE/ML INJECTABLE INJECTION Discontinued -

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 0.1% BASE	CREAM	TOPICAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 3MG BASE/GM	OINTMENT	OPHTHALMIC	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 0.1% BASE	OINTMENT	TOPICAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 0.3% BASE	SOLUTION/DROPS	OPHTHALMIC	Discontinued	-

GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

BAXTER HLTHCAREANDA 062373198210 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 0.8MG BASE/ML	INJECTABLE	INJECTION	Discontinued	-
EQ 80MG BASE/100ML	INJECTABLE	INJECTION	Rx	-
EQ 40MG BASE/100ML	INJECTABLE	INJECTION	Discontinued	-
EQ 60MG BASE/100ML	INJECTABLE	INJECTION	Discontinued	-
EQ 100MG BASE/100ML	INJECTABLE	INJECTION	Rx	-
EQ 120MG BASE/100ML	INJECTABLE	INJECTION	Rx	-
EQ 1.2MG BASE/ML	INJECTABLE	INJECTION	Rx	-
EQ 1.6MG BASE/ML	INJECTABLE	INJECTION	Rx	-
EQ 2MG BASE/ML	INJECTABLE	INJECTION	Rx	-
EQ 2.4MG BASE/ML	INJECTABLE	INJECTION	Discontinued	-

GENTAMICIN

INTL MEDICATIONANDA 06232519823 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 40MG BASE/ML	INJECTABLE	INJECTION	Discontinued	-
EQ 1MG BASE/ML	INJECTABLE	INJECTION	Discontinued	-
EQ 100MG BASE/100ML	INJECTABLE	INJECTION	Discontinued	-

GENTAMICIN SULFATE
KALAPHARMANDA 0623541982
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 40MG BASE/ML INJECTABLE INJECTION Discontinued -
GENTAMICIN SULFATE
FRESENIUS KABI USAANDA 06235619822 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 10MG BASE/ML INJECTABLE INJECTION Discontinued -
EQ 40MG BASE/ML INJECTABLE INJECTION Discontinued -
GENTAMICIN SULFATERS
PADAGIS USANDA 0623511982
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 0.1% BASE OINTMENT TOPICAL Rx AT
GARAMYCIN
SCHERINGANDA 060462-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 0.1% BASE CREAM TOPICAL Discontinued -
GENTAMICIN SULFATERS
PADAGIS USANDA 062307-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 0.1% BASE CREAM TOPICAL Rx AT
APOGEN
KING PHARMSANDA 062289-2 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 10MG BASE/ML INJECTABLE INJECTION Discontinued -
EQ 40MG BASE/ML INJECTABLE INJECTION Discontinued -
BRISTAGEN
BRISTOLANDA 062288-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 40MG BASE/ML INJECTABLE INJECTION Discontinued -
GARAMYCIN
SCHERINGANDA 061716-2 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 40MG BASE/ML INJECTABLE INJECTION Discontinued -
EQ 1MG BASE/ML INJECTABLE INJECTION Discontinued -
GARAMYCIN
SCHERINGANDA 061739-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 10MG BASE/ML INJECTABLE INJECTION Discontinued -
GENTAMICIN SULFATE
HIKMAANDA 062251-2 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 40MG BASE/ML INJECTABLE INJECTION Rx AP
EQ 10MG BASE/ML INJECTABLE INJECTION Rx AP
GENTAMICIN SULFATE
WATSON LABSANDA 062318-2 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 40MG BASE/ML INJECTABLE INJECTION Discontinued -
EQ 10MG BASE/ML INJECTABLE INJECTION Discontinued -
GENTAMICIN SULFATE
WYETH AYERSTANDA 062264-2 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 10MG BASE/ML INJECTABLE INJECTION Discontinued -
EQ 40MG BASE/ML INJECTABLE INJECTION Discontinued -
U-GENCIN
PHARMACIA AND UPJOHNANDA 062248-2 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 10MG BASE/ML INJECTABLE INJECTION Discontinued -
EQ 40MG BASE/ML INJECTABLE INJECTION Discontinued -
GARAMYCIN
SCHERINGANDA 060463-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 0.1% BASE OINTMENT TOPICAL Discontinued -
GENTAMICIN SULFATERS
SANDOZANDA 062196-
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 0.3% BASE SOLUTION/DROPS OPHTHALMIC Rx AT

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 10MG BASE/ML	INJECTABLE	INJECTION	Discontinued	-
EQ 40MG BASE/ML	INJECTABLE	INJECTION	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 0.1% BASE	OINTMENT	TOPICAL	Rx	AT

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 0.1% BASE	CREAM	TOPICAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 0.1% BASE	CREAM	TOPICAL	Rx	AT

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

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First approval

Feb 18, 1982

45 yr 4 mo ago

Most recent approval

Jan 08, 2024

2 yr 10 mo ago

Approvals span 1982–2024 across 60 FDA applications.

Brand (NDA) 35%

Generic (ANDA) 5795%

Gentamicin 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.

Ask AI about Gentamicin sulfate

Key facts