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Last Updated: November 22, 2024

List of Excipients in API leuprolide acetate

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Excipients in NDA-approved (novel) drugs containing leuprolide acetate

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Company	Tradename	Ingredient	NDC	Excipient	Potential Generic Entry
TOLMAR Inc	FENSOLVI	leuprolide acetate	62935-163	METHYL PYRROLIDONE
TOLMAR Inc	FENSOLVI	leuprolide acetate	62935-163	POLY(DL-LACTIC-CO-GLYCOLIC ACID)
TOLMAR Inc	ELIGARD	leuprolide acetate	62935-461	METHYL PYRROLIDONE
TOLMAR Inc	ELIGARD	leuprolide acetate	62935-461	POLY(DL-LACTIC-CO-GLYCOLIC ACID)
TOLMAR Inc	ELIGARD	leuprolide acetate	62935-756	METHYL PYRROLIDONE
>Company	>Tradename	>Ingredient	>NDC	>Excipient	>Potential Generic Entry

Excipients in ANDA-approved (generic) drugs containing leuprolide acetate

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Company	Ingredient	NDC	Excipient
Eon Labs Inc	leuprolide acetate	0185-7400	ACETIC ACID
Eon Labs Inc	leuprolide acetate	0185-7400	BENZYL ALCOHOL
Eon Labs Inc	leuprolide acetate	0185-7400	SODIUM CHLORIDE
Eon Labs Inc	leuprolide acetate	0185-7400	SODIUM HYDROXIDE
>Company	>Ingredient	>NDC	>Excipient

Detailed excipient profiles for leuprolide acetate

Excipient focus: ACETIC ACID

leuprolide acetate drug variants containing ACETIC ACID

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Company	Ingredient	NDC
Eon Labs Inc	leuprolide acetate	0185-7400
>Company	>Ingredient	>NDC

leuprolide acetate drug variants not containing ACETIC ACID

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Company	Ingredient	NDC
TOLMAR Inc	leuprolide acetate	62935-163
TOLMAR Inc	leuprolide acetate	62935-461
TOLMAR Inc	leuprolide acetate	62935-756
>Company	>Ingredient	>NDC

Excipient focus: BENZYL ALCOHOL

leuprolide acetate drug variants containing BENZYL ALCOHOL

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Company	Ingredient	NDC
Eon Labs Inc	leuprolide acetate	0185-7400
>Company	>Ingredient	>NDC

leuprolide acetate drug variants not containing BENZYL ALCOHOL

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Company	Ingredient	NDC
TOLMAR Inc	leuprolide acetate	62935-163
TOLMAR Inc	leuprolide acetate	62935-461
TOLMAR Inc	leuprolide acetate	62935-756
>Company	>Ingredient	>NDC

Excipient focus: METHYL PYRROLIDONE

leuprolide acetate drug variants containing METHYL PYRROLIDONE

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Company	Ingredient	NDC
TOLMAR Inc	leuprolide acetate	62935-163
TOLMAR Inc	leuprolide acetate	62935-461
TOLMAR Inc	leuprolide acetate	62935-756
>Company	>Ingredient	>NDC

leuprolide acetate drug variants not containing METHYL PYRROLIDONE

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Company	Ingredient	NDC
Eon Labs Inc	leuprolide acetate	0185-7400
>Company	>Ingredient	>NDC

Excipient focus: POLY(DL-LACTIC-CO-GLYCOLIC ACID)

leuprolide acetate drug variants containing POLY(DL-LACTIC-CO-GLYCOLIC ACID)

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Company	Ingredient	NDC
TOLMAR Inc	leuprolide acetate	62935-163
TOLMAR Inc	leuprolide acetate	62935-461
TOLMAR Inc	leuprolide acetate	62935-756
>Company	>Ingredient	>NDC

leuprolide acetate drug variants not containing POLY(DL-LACTIC-CO-GLYCOLIC ACID)

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Company	Ingredient	NDC
Eon Labs Inc	leuprolide acetate	0185-7400
>Company	>Ingredient	>NDC

Excipient focus: SODIUM CHLORIDE

leuprolide acetate drug variants containing SODIUM CHLORIDE

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Company	Ingredient	NDC
Eon Labs Inc	leuprolide acetate	0185-7400
>Company	>Ingredient	>NDC

leuprolide acetate drug variants not containing SODIUM CHLORIDE

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Company	Ingredient	NDC
TOLMAR Inc	leuprolide acetate	62935-163
TOLMAR Inc	leuprolide acetate	62935-461
TOLMAR Inc	leuprolide acetate	62935-756
>Company	>Ingredient	>NDC

Excipient focus: SODIUM HYDROXIDE

leuprolide acetate drug variants containing SODIUM HYDROXIDE

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Company	Ingredient	NDC
Eon Labs Inc	leuprolide acetate	0185-7400
>Company	>Ingredient	>NDC

leuprolide acetate drug variants not containing SODIUM HYDROXIDE

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Company	Ingredient	NDC
TOLMAR Inc	leuprolide acetate	62935-163
TOLMAR Inc	leuprolide acetate	62935-461
TOLMAR Inc	leuprolide acetate	62935-756
>Company	>Ingredient	>NDC

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