List of Excipients in API epinastine hydrochloride

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Excipients in NDA-approved (novel) drugs containing epinastine hydrochloride

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Company	Tradename	Ingredient	NDC	Excipient	Potential Generic Entry
Allergan Inc	ELESTAT	epinastine hydrochloride	0023-9201	BENZALKONIUM CHLORIDE
Allergan Inc	ELESTAT	epinastine hydrochloride	0023-9201	EDETATE DISODIUM
Allergan Inc	ELESTAT	epinastine hydrochloride	0023-9201	HYDROCHLORIC ACID
Allergan Inc	ELESTAT	epinastine hydrochloride	0023-9201	SODIUM CHLORIDE
>Company	>Tradename	>Ingredient	>NDC	>Excipient	>Potential Generic Entry

Excipients in ANDA-approved (generic) drugs containing epinastine hydrochloride

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Company	Ingredient	NDC	Excipient
Akorn	epinastine hydrochloride	17478-911	BENZALKONIUM CHLORIDE
Akorn	epinastine hydrochloride	17478-911	EDETATE DISODIUM
Akorn	epinastine hydrochloride	17478-911	HYDROCHLORIC ACID
Akorn	epinastine hydrochloride	17478-911	SODIUM CHLORIDE
>Company	>Ingredient	>NDC	>Excipient

Detailed excipient profiles for epinastine hydrochloride

Excipient focus: BENZALKONIUM CHLORIDE

epinastine hydrochloride drug variants containing BENZALKONIUM CHLORIDE

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Company	Ingredient	NDC
Allergan Inc	epinastine hydrochloride	0023-9201
Akorn	epinastine hydrochloride	17478-911
Breckenridge Pharmaceutical Inc	epinastine hydrochloride	51991-836
Sun Pharmaceutical Industries Inc	epinastine hydrochloride	62756-329
>Company	>Ingredient	>NDC

epinastine hydrochloride drug variants not containing BENZALKONIUM CHLORIDE

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Company	Ingredient	NDC
>Company	>Ingredient	>NDC

Excipient focus: EDETATE DISODIUM

epinastine hydrochloride drug variants containing EDETATE DISODIUM

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Company	Ingredient	NDC
Allergan Inc	epinastine hydrochloride	0023-9201
Akorn	epinastine hydrochloride	17478-911
Sun Pharmaceutical Industries Inc	epinastine hydrochloride	62756-329
Somerset Therapeutics LLC	epinastine hydrochloride	70069-008
>Company	>Ingredient	>NDC

epinastine hydrochloride drug variants not containing EDETATE DISODIUM

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Company	Ingredient	NDC
Breckenridge Pharmaceutical Inc	epinastine hydrochloride	51991-836
>Company	>Ingredient	>NDC

Excipient focus: EDETATE SODIUM

epinastine hydrochloride drug variants containing EDETATE SODIUM

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Company	Ingredient	NDC
Breckenridge Pharmaceutical Inc	epinastine hydrochloride	51991-836
>Company	>Ingredient	>NDC

epinastine hydrochloride drug variants not containing EDETATE SODIUM

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Company	Ingredient	NDC
Allergan Inc	epinastine hydrochloride	0023-9201
Akorn	epinastine hydrochloride	17478-911
Sun Pharmaceutical Industries Inc	epinastine hydrochloride	62756-329
Somerset Therapeutics LLC	epinastine hydrochloride	70069-008
>Company	>Ingredient	>NDC

Excipient focus: HYDROCHLORIC ACID

epinastine hydrochloride drug variants containing HYDROCHLORIC ACID

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Company	Ingredient	NDC
Allergan Inc	epinastine hydrochloride	0023-9201
Akorn	epinastine hydrochloride	17478-911
Breckenridge Pharmaceutical Inc	epinastine hydrochloride	51991-836
Sun Pharmaceutical Industries Inc	epinastine hydrochloride	62756-329
>Company	>Ingredient	>NDC

epinastine hydrochloride drug variants not containing HYDROCHLORIC ACID

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Company	Ingredient	NDC
>Company	>Ingredient	>NDC

Excipient focus: SODIUM CHLORIDE

epinastine hydrochloride drug variants containing SODIUM CHLORIDE

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Company	Ingredient	NDC
Allergan Inc	epinastine hydrochloride	0023-9201
Akorn	epinastine hydrochloride	17478-911
Breckenridge Pharmaceutical Inc	epinastine hydrochloride	51991-836
Sun Pharmaceutical Industries Inc	epinastine hydrochloride	62756-329
>Company	>Ingredient	>NDC

epinastine hydrochloride drug variants not containing SODIUM CHLORIDE

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Company	Ingredient	NDC
>Company	>Ingredient	>NDC

Excipient focus: SODIUM HYDROXIDE

epinastine hydrochloride drug variants containing SODIUM HYDROXIDE

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Company	Ingredient	NDC
Allergan Inc	epinastine hydrochloride	0023-9201
Akorn	epinastine hydrochloride	17478-911
Breckenridge Pharmaceutical Inc	epinastine hydrochloride	51991-836
Sun Pharmaceutical Industries Inc	epinastine hydrochloride	62756-329
>Company	>Ingredient	>NDC

epinastine hydrochloride drug variants not containing SODIUM HYDROXIDE

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Company	Ingredient	NDC
>Company	>Ingredient	>NDC

Excipient focus: SODIUM PHOSPHATE, MONOBASIC

epinastine hydrochloride drug variants containing SODIUM PHOSPHATE, MONOBASIC

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Company	Ingredient	NDC
Allergan Inc	epinastine hydrochloride	0023-9201
Akorn	epinastine hydrochloride	17478-911
Somerset Therapeutics LLC	epinastine hydrochloride	70069-008
>Company	>Ingredient	>NDC

epinastine hydrochloride drug variants not containing SODIUM PHOSPHATE, MONOBASIC

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Company	Ingredient	NDC
Breckenridge Pharmaceutical Inc	epinastine hydrochloride	51991-836
Sun Pharmaceutical Industries Inc	epinastine hydrochloride	62756-329
>Company	>Ingredient	>NDC

Excipient focus: SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS

epinastine hydrochloride drug variants containing SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS

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Company	Ingredient	NDC
Breckenridge Pharmaceutical Inc	epinastine hydrochloride	51991-836
>Company	>Ingredient	>NDC

epinastine hydrochloride drug variants not containing SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS

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Company	Ingredient	NDC
Allergan Inc	epinastine hydrochloride	0023-9201
Akorn	epinastine hydrochloride	17478-911
Sun Pharmaceutical Industries Inc	epinastine hydrochloride	62756-329
Somerset Therapeutics LLC	epinastine hydrochloride	70069-008
>Company	>Ingredient	>NDC

Excipient focus: SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE

epinastine hydrochloride drug variants containing SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE

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Company	Ingredient	NDC
Sun Pharmaceutical Industries Inc	epinastine hydrochloride	62756-329
>Company	>Ingredient	>NDC

epinastine hydrochloride drug variants not containing SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE

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Company	Ingredient	NDC
Allergan Inc	epinastine hydrochloride	0023-9201
Akorn	epinastine hydrochloride	17478-911
Breckenridge Pharmaceutical Inc	epinastine hydrochloride	51991-836
Somerset Therapeutics LLC	epinastine hydrochloride	70069-008
>Company	>Ingredient	>NDC

Excipient focus: WATER

epinastine hydrochloride drug variants containing WATER

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Company	Ingredient	NDC
Allergan Inc	epinastine hydrochloride	0023-9201
Akorn	epinastine hydrochloride	17478-911
Breckenridge Pharmaceutical Inc	epinastine hydrochloride	51991-836
Sun Pharmaceutical Industries Inc	epinastine hydrochloride	62756-329
>Company	>Ingredient	>NDC

epinastine hydrochloride drug variants not containing WATER

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Company	Ingredient	NDC
>Company	>Ingredient	>NDC

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