List of Excipients in API cladribine

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Excipients in NDA-approved (novel) drugs containing cladribine

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Company	Tradename	Ingredient	NDC	Excipient	Potential Generic Entry
EMD Serono Inc	MAVENCLAD	cladribine	44087-4000	HYDROXYPROPYL BETADEX
EMD Serono Inc	MAVENCLAD	cladribine	44087-4000	MAGNESIUM STEARATE
EMD Serono Inc	MAVENCLAD	cladribine	44087-4000	SORBITOL
>Company	>Tradename	>Ingredient	>NDC	>Excipient	>Potential Generic Entry

Excipients in ANDA-approved (generic) drugs containing cladribine

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Company	Ingredient	NDC	Excipient
Hikma Pharmaceuticals USA Inc	cladribine	0143-9871	PHOSPHORIC ACID
Hikma Pharmaceuticals USA Inc	cladribine	0143-9871	SODIUM CHLORIDE
Hikma Pharmaceuticals USA Inc	cladribine	0143-9871	SODIUM PHOSPHATE, DIBASIC
Hisun Pharmaceuticals USA Inc	cladribine	42658-010	PHOSPHORIC ACID
Hisun Pharmaceuticals USA Inc	cladribine	42658-010	SODIUM CHLORIDE
Hisun Pharmaceuticals USA Inc	cladribine	42658-010	SODIUM PHOSPHATE DIBASIC DIHYDRATE
Hisun Pharmaceuticals USA Inc	cladribine	42658-010	WATER
>Company	>Ingredient	>NDC	>Excipient

Detailed excipient profiles for cladribine

Excipient focus: HYDROXYPROPYL BETADEX

cladribine drug variants containing HYDROXYPROPYL BETADEX

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Company	Ingredient	NDC
EMD Serono Inc	cladribine	44087-4000
>Company	>Ingredient	>NDC

cladribine drug variants not containing HYDROXYPROPYL BETADEX

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Company	Ingredient	NDC
Hikma Pharmaceuticals USA Inc	cladribine	0143-9871
Hisun Pharmaceuticals USA Inc	cladribine	42658-010
Fresenius Kabi USA LLC	cladribine	63323-140
Mylan Institutional LLC	cladribine	67457-450
>Company	>Ingredient	>NDC

Excipient focus: MAGNESIUM STEARATE

cladribine drug variants containing MAGNESIUM STEARATE

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Company	Ingredient	NDC
EMD Serono Inc	cladribine	44087-4000
>Company	>Ingredient	>NDC

cladribine drug variants not containing MAGNESIUM STEARATE

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Company	Ingredient	NDC
Hikma Pharmaceuticals USA Inc	cladribine	0143-9871
Hisun Pharmaceuticals USA Inc	cladribine	42658-010
Fresenius Kabi USA LLC	cladribine	63323-140
Mylan Institutional LLC	cladribine	67457-450
>Company	>Ingredient	>NDC

Excipient focus: PHOSPHORIC ACID

cladribine drug variants containing PHOSPHORIC ACID

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Company	Ingredient	NDC
Hikma Pharmaceuticals USA Inc	cladribine	0143-9871
Hisun Pharmaceuticals USA Inc	cladribine	42658-010
Fresenius Kabi USA LLC	cladribine	63323-140
Mylan Institutional LLC	cladribine	67457-450
>Company	>Ingredient	>NDC

cladribine drug variants not containing PHOSPHORIC ACID

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Company	Ingredient	NDC
EMD Serono Inc	cladribine	44087-4000
>Company	>Ingredient	>NDC

Excipient focus: SODIUM CHLORIDE

cladribine drug variants containing SODIUM CHLORIDE

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Company	Ingredient	NDC
Hikma Pharmaceuticals USA Inc	cladribine	0143-9871
Hisun Pharmaceuticals USA Inc	cladribine	42658-010
Fresenius Kabi USA LLC	cladribine	63323-140
Mylan Institutional LLC	cladribine	67457-450
>Company	>Ingredient	>NDC

cladribine drug variants not containing SODIUM CHLORIDE

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Company	Ingredient	NDC
EMD Serono Inc	cladribine	44087-4000
>Company	>Ingredient	>NDC

Excipient focus: SODIUM PHOSPHATE DIBASIC DIHYDRATE

cladribine drug variants containing SODIUM PHOSPHATE DIBASIC DIHYDRATE

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Company	Ingredient	NDC
Hisun Pharmaceuticals USA Inc	cladribine	42658-010
>Company	>Ingredient	>NDC

cladribine drug variants not containing SODIUM PHOSPHATE DIBASIC DIHYDRATE

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Company	Ingredient	NDC
Hikma Pharmaceuticals USA Inc	cladribine	0143-9871
EMD Serono Inc	cladribine	44087-4000
Fresenius Kabi USA LLC	cladribine	63323-140
Mylan Institutional LLC	cladribine	67457-450
>Company	>Ingredient	>NDC

Excipient focus: SODIUM PHOSPHATE, DIBASIC

cladribine drug variants containing SODIUM PHOSPHATE, DIBASIC

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Company	Ingredient	NDC
Hikma Pharmaceuticals USA Inc	cladribine	0143-9871
Fresenius Kabi USA LLC	cladribine	63323-140
Mylan Institutional LLC	cladribine	67457-450
>Company	>Ingredient	>NDC

cladribine drug variants not containing SODIUM PHOSPHATE, DIBASIC

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Company	Ingredient	NDC
Hisun Pharmaceuticals USA Inc	cladribine	42658-010
EMD Serono Inc	cladribine	44087-4000
>Company	>Ingredient	>NDC

Excipient focus: SORBITOL

cladribine drug variants containing SORBITOL

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Company	Ingredient	NDC
EMD Serono Inc	cladribine	44087-4000
>Company	>Ingredient	>NDC

cladribine drug variants not containing SORBITOL

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Company	Ingredient	NDC
Hikma Pharmaceuticals USA Inc	cladribine	0143-9871
Hisun Pharmaceuticals USA Inc	cladribine	42658-010
Fresenius Kabi USA LLC	cladribine	63323-140
Mylan Institutional LLC	cladribine	67457-450
>Company	>Ingredient	>NDC

Excipient focus: WATER

cladribine drug variants containing WATER

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Company	Ingredient	NDC
Hisun Pharmaceuticals USA Inc	cladribine	42658-010
>Company	>Ingredient	>NDC

cladribine drug variants not containing WATER

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Company	Ingredient	NDC
Hikma Pharmaceuticals USA Inc	cladribine	0143-9871
EMD Serono Inc	cladribine	44087-4000
Fresenius Kabi USA LLC	cladribine	63323-140
Mylan Institutional LLC	cladribine	67457-450
>Company	>Ingredient	>NDC

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