List of Excipients in API nitisinone

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Excipients in NDA-approved (novel) drugs containing nitisinone

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Company	Tradename	Ingredient	NDC	Excipient	Potential Generic Entry
SWEDISH ORPHAN BIOVITRUM AB (PUBL)	ORFADIN	nitisinone	66658-102	GELATIN
SWEDISH ORPHAN BIOVITRUM AB (PUBL)	ORFADIN	nitisinone	66658-102	STARCH, CORN
SWEDISH ORPHAN BIOVITRUM AB (PUBL)	ORFADIN	nitisinone	66658-102	TITANIUM DIOXIDE
>Company	>Tradename	>Ingredient	>NDC	>Excipient	>Potential Generic Entry

Excipients in ANDA-approved (generic) drugs containing nitisinone

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Company	Ingredient	NDC	Excipient
Par Pharmaceutical Inc	nitisinone	0254-3020	AMMONIA
Par Pharmaceutical Inc	nitisinone	0254-3020	ANHYDROUS CITRIC ACID
Par Pharmaceutical Inc	nitisinone	0254-3020	FERROSOFERRIC OXIDE
>Company	>Ingredient	>NDC	>Excipient

Detailed excipient profiles for nitisinone

Excipient focus: AMMONIA

nitisinone drug variants containing AMMONIA

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Company	Ingredient	NDC
Par Pharmaceutical Inc	nitisinone	0254-3020
Torrent pharmaceuticals limited	nitisinone	13668-629
Bryant Ranch Prepack	nitisinone	63629-2233
>Company	>Ingredient	>NDC

nitisinone drug variants not containing AMMONIA

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Company	Ingredient	NDC
SWEDISH ORPHAN BIOVITRUM AB (PUBL)	nitisinone	66658-102
Swedish Orphan Biovitrum AB (publ)	nitisinone	66658-204
Cycle Pharmaceuticals Ltd	nitisinone	70709-002
>Company	>Ingredient	>NDC

Excipient focus: ANHYDROUS CITRIC ACID

nitisinone drug variants containing ANHYDROUS CITRIC ACID

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Company	Ingredient	NDC
Par Pharmaceutical Inc	nitisinone	0254-3020
Bryant Ranch Prepack	nitisinone	63629-2233
Bryant Ranch Prepack	nitisinone	63629-2234
>Company	>Ingredient	>NDC

nitisinone drug variants not containing ANHYDROUS CITRIC ACID

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Company	Ingredient	NDC
Torrent pharmaceuticals limited	nitisinone	13668-629
SWEDISH ORPHAN BIOVITRUM AB (PUBL)	nitisinone	66658-102
Swedish Orphan Biovitrum AB (publ)	nitisinone	66658-204
>Company	>Ingredient	>NDC

Excipient focus: ANHYDROUS LACTOSE

nitisinone drug variants containing ANHYDROUS LACTOSE

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Company	Ingredient	NDC
Eton Pharmaceuticals Inc	nitisinone	71863-119
>Company	>Ingredient	>NDC

nitisinone drug variants not containing ANHYDROUS LACTOSE

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Company	Ingredient	NDC
Par Pharmaceutical Inc	nitisinone	0254-3020
Torrent pharmaceuticals limited	nitisinone	13668-629
Bryant Ranch Prepack	nitisinone	63629-2233
>Company	>Ingredient	>NDC

Excipient focus: CITRIC ACID MONOHYDRATE

nitisinone drug variants containing CITRIC ACID MONOHYDRATE

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Company	Ingredient	NDC
Swedish Orphan Biovitrum AB (publ)	nitisinone	66658-204
>Company	>Ingredient	>NDC

nitisinone drug variants not containing CITRIC ACID MONOHYDRATE

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Company	Ingredient	NDC
Par Pharmaceutical Inc	nitisinone	0254-3020
Torrent pharmaceuticals limited	nitisinone	13668-629
Bryant Ranch Prepack	nitisinone	63629-2233
>Company	>Ingredient	>NDC

Excipient focus: FD&C BLUE NO. 2--ALUMINUM LAKE

nitisinone drug variants containing FD&C BLUE NO. 2--ALUMINUM LAKE

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Company	Ingredient	NDC
Analog Pharma	nitisinone	70505-202
>Company	>Ingredient	>NDC

nitisinone drug variants not containing FD&C BLUE NO. 2--ALUMINUM LAKE

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Company	Ingredient	NDC
Par Pharmaceutical Inc	nitisinone	0254-3020
Torrent pharmaceuticals limited	nitisinone	13668-629
Bryant Ranch Prepack	nitisinone	63629-2233
>Company	>Ingredient	>NDC

Excipient focus: FERROSOFERRIC OXIDE

nitisinone drug variants containing FERROSOFERRIC OXIDE

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Company	Ingredient	NDC
Par Pharmaceutical Inc	nitisinone	0254-3020
Bryant Ranch Prepack	nitisinone	63629-2233
Bryant Ranch Prepack	nitisinone	63629-2234
>Company	>Ingredient	>NDC

nitisinone drug variants not containing FERROSOFERRIC OXIDE

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Company	Ingredient	NDC
Torrent pharmaceuticals limited	nitisinone	13668-629
SWEDISH ORPHAN BIOVITRUM AB (PUBL)	nitisinone	66658-102
Swedish Orphan Biovitrum AB (publ)	nitisinone	66658-204
>Company	>Ingredient	>NDC

Excipient focus: GELATIN

nitisinone drug variants containing GELATIN

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Company	Ingredient	NDC
Par Pharmaceutical Inc	nitisinone	0254-3020
Torrent pharmaceuticals limited	nitisinone	13668-629
Bryant Ranch Prepack	nitisinone	63629-2233
>Company	>Ingredient	>NDC

nitisinone drug variants not containing GELATIN

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Company	Ingredient	NDC
Swedish Orphan Biovitrum AB (publ)	nitisinone	66658-204
Cycle Pharmaceuticals Ltd	nitisinone	70709-002
Eton Pharmaceuticals Inc	nitisinone	71863-119
>Company	>Ingredient	>NDC

Excipient focus: GLYCERIN

nitisinone drug variants containing GLYCERIN

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Company	Ingredient	NDC
Swedish Orphan Biovitrum AB (publ)	nitisinone	66658-204
>Company	>Ingredient	>NDC

nitisinone drug variants not containing GLYCERIN

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Company	Ingredient	NDC
Par Pharmaceutical Inc	nitisinone	0254-3020
Torrent pharmaceuticals limited	nitisinone	13668-629
Bryant Ranch Prepack	nitisinone	63629-2233
>Company	>Ingredient	>NDC

Excipient focus: GLYCERYL DIBEHENATE

nitisinone drug variants containing GLYCERYL DIBEHENATE

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Company	Ingredient	NDC
Cycle Pharmaceuticals Ltd	nitisinone	70709-002
>Company	>Ingredient	>NDC

nitisinone drug variants not containing GLYCERYL DIBEHENATE

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Company	Ingredient	NDC
Par Pharmaceutical Inc	nitisinone	0254-3020
Torrent pharmaceuticals limited	nitisinone	13668-629
Bryant Ranch Prepack	nitisinone	63629-2233
>Company	>Ingredient	>NDC

Excipient focus: HYPROMELLOSE 2910

nitisinone drug variants containing HYPROMELLOSE 2910

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Company	Ingredient	NDC
Par Pharmaceutical Inc	nitisinone	0254-3020
Bryant Ranch Prepack	nitisinone	63629-2233
Bryant Ranch Prepack	nitisinone	63629-2234
>Company	>Ingredient	>NDC

nitisinone drug variants not containing HYPROMELLOSE 2910

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Company	Ingredient	NDC
Torrent pharmaceuticals limited	nitisinone	13668-629
SWEDISH ORPHAN BIOVITRUM AB (PUBL)	nitisinone	66658-102
Swedish Orphan Biovitrum AB (publ)	nitisinone	66658-204
>Company	>Ingredient	>NDC

Excipient focus: HYPROMELLOSES

nitisinone drug variants containing HYPROMELLOSES

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Company	Ingredient	NDC
Swedish Orphan Biovitrum AB (publ)	nitisinone	66658-204
>Company	>Ingredient	>NDC

nitisinone drug variants not containing HYPROMELLOSES

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Company	Ingredient	NDC
Par Pharmaceutical Inc	nitisinone	0254-3020
Torrent pharmaceuticals limited	nitisinone	13668-629
Bryant Ranch Prepack	nitisinone	63629-2233
>Company	>Ingredient	>NDC

Excipient focus: LACTOSE MONOHYDRATE

nitisinone drug variants containing LACTOSE MONOHYDRATE

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Company	Ingredient	NDC
Cycle Pharmaceuticals Ltd	nitisinone	70709-002
>Company	>Ingredient	>NDC

nitisinone drug variants not containing LACTOSE MONOHYDRATE

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Company	Ingredient	NDC
Par Pharmaceutical Inc	nitisinone	0254-3020
Torrent pharmaceuticals limited	nitisinone	13668-629
Bryant Ranch Prepack	nitisinone	63629-2233
>Company	>Ingredient	>NDC

Excipient focus: MANNITOL

nitisinone drug variants containing MANNITOL

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Company	Ingredient	NDC
Par Pharmaceutical Inc	nitisinone	0254-3020
Bryant Ranch Prepack	nitisinone	63629-2233
Bryant Ranch Prepack	nitisinone	63629-2234
>Company	>Ingredient	>NDC

nitisinone drug variants not containing MANNITOL

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Company	Ingredient	NDC
Torrent pharmaceuticals limited	nitisinone	13668-629
SWEDISH ORPHAN BIOVITRUM AB (PUBL)	nitisinone	66658-102
Swedish Orphan Biovitrum AB (publ)	nitisinone	66658-204
>Company	>Ingredient	>NDC

Excipient focus: MODIFIED CORN STARCH

nitisinone drug variants containing MODIFIED CORN STARCH

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Company	Ingredient	NDC
Analog Pharma	nitisinone	70505-202
>Company	>Ingredient	>NDC

nitisinone drug variants not containing MODIFIED CORN STARCH

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Company	Ingredient	NDC
Par Pharmaceutical Inc	nitisinone	0254-3020
Torrent pharmaceuticals limited	nitisinone	13668-629
Bryant Ranch Prepack	nitisinone	63629-2233
>Company	>Ingredient	>NDC

Excipient focus: POLYSORBATE 80

nitisinone drug variants containing POLYSORBATE 80

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Company	Ingredient	NDC
Swedish Orphan Biovitrum AB (publ)	nitisinone	66658-204
>Company	>Ingredient	>NDC

nitisinone drug variants not containing POLYSORBATE 80

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Company	Ingredient	NDC
Par Pharmaceutical Inc	nitisinone	0254-3020
Torrent pharmaceuticals limited	nitisinone	13668-629
Bryant Ranch Prepack	nitisinone	63629-2233
>Company	>Ingredient	>NDC

Excipient focus: POTASSIUM HYDROXIDE

nitisinone drug variants containing POTASSIUM HYDROXIDE

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Company	Ingredient	NDC
Par Pharmaceutical Inc	nitisinone	0254-3020
Bryant Ranch Prepack	nitisinone	63629-2233
Bryant Ranch Prepack	nitisinone	63629-2234
>Company	>Ingredient	>NDC

nitisinone drug variants not containing POTASSIUM HYDROXIDE

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Company	Ingredient	NDC
Torrent pharmaceuticals limited	nitisinone	13668-629
SWEDISH ORPHAN BIOVITRUM AB (PUBL)	nitisinone	66658-102
Swedish Orphan Biovitrum AB (publ)	nitisinone	66658-204
>Company	>Ingredient	>NDC

Excipient focus: PROPYLENE GLYCOL

nitisinone drug variants containing PROPYLENE GLYCOL

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Company	Ingredient	NDC
Par Pharmaceutical Inc	nitisinone	0254-3020
Torrent pharmaceuticals limited	nitisinone	13668-629
Bryant Ranch Prepack	nitisinone	63629-2233
>Company	>Ingredient	>NDC

nitisinone drug variants not containing PROPYLENE GLYCOL

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Company	Ingredient	NDC
SWEDISH ORPHAN BIOVITRUM AB (PUBL)	nitisinone	66658-102
Swedish Orphan Biovitrum AB (publ)	nitisinone	66658-204
Cycle Pharmaceuticals Ltd	nitisinone	70709-002
>Company	>Ingredient	>NDC

Excipient focus: SHELLAC

nitisinone drug variants containing SHELLAC

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Company	Ingredient	NDC
Analog Pharma	nitisinone	70505-202
>Company	>Ingredient	>NDC

nitisinone drug variants not containing SHELLAC

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Company	Ingredient	NDC
Par Pharmaceutical Inc	nitisinone	0254-3020
Torrent pharmaceuticals limited	nitisinone	13668-629
Bryant Ranch Prepack	nitisinone	63629-2233
>Company	>Ingredient	>NDC

Excipient focus: SODIUM BENZOATE

nitisinone drug variants containing SODIUM BENZOATE

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Company	Ingredient	NDC
Swedish Orphan Biovitrum AB (publ)	nitisinone	66658-204
>Company	>Ingredient	>NDC

nitisinone drug variants not containing SODIUM BENZOATE

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Company	Ingredient	NDC
Par Pharmaceutical Inc	nitisinone	0254-3020
Torrent pharmaceuticals limited	nitisinone	13668-629
Bryant Ranch Prepack	nitisinone	63629-2233
>Company	>Ingredient	>NDC

Excipient focus: SODIUM LAURYL SULFATE

nitisinone drug variants containing SODIUM LAURYL SULFATE

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Company	Ingredient	NDC
Par Pharmaceutical Inc	nitisinone	0254-3020
Bryant Ranch Prepack	nitisinone	63629-2233
Bryant Ranch Prepack	nitisinone	63629-2234
>Company	>Ingredient	>NDC

nitisinone drug variants not containing SODIUM LAURYL SULFATE

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Company	Ingredient	NDC
Torrent pharmaceuticals limited	nitisinone	13668-629
SWEDISH ORPHAN BIOVITRUM AB (PUBL)	nitisinone	66658-102
Swedish Orphan Biovitrum AB (publ)	nitisinone	66658-204
>Company	>Ingredient	>NDC

Excipient focus: STARCH, CORN

nitisinone drug variants containing STARCH, CORN

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Company	Ingredient	NDC
Torrent pharmaceuticals limited	nitisinone	13668-629
SWEDISH ORPHAN BIOVITRUM AB (PUBL)	nitisinone	66658-102
>Company	>Ingredient	>NDC

nitisinone drug variants not containing STARCH, CORN

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Company	Ingredient	NDC
Par Pharmaceutical Inc	nitisinone	0254-3020
Bryant Ranch Prepack	nitisinone	63629-2233
Bryant Ranch Prepack	nitisinone	63629-2234
>Company	>Ingredient	>NDC

Excipient focus: STEARIC ACID

nitisinone drug variants containing STEARIC ACID

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Company	Ingredient	NDC
Par Pharmaceutical Inc	nitisinone	0254-3020
Bryant Ranch Prepack	nitisinone	63629-2233
Bryant Ranch Prepack	nitisinone	63629-2234
>Company	>Ingredient	>NDC

nitisinone drug variants not containing STEARIC ACID

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Company	Ingredient	NDC
Torrent pharmaceuticals limited	nitisinone	13668-629
SWEDISH ORPHAN BIOVITRUM AB (PUBL)	nitisinone	66658-102
Swedish Orphan Biovitrum AB (publ)	nitisinone	66658-204
>Company	>Ingredient	>NDC

Excipient focus: TITANIUM DIOXIDE

nitisinone drug variants containing TITANIUM DIOXIDE

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Company	Ingredient	NDC
Par Pharmaceutical Inc	nitisinone	0254-3020
Torrent pharmaceuticals limited	nitisinone	13668-629
Bryant Ranch Prepack	nitisinone	63629-2233
>Company	>Ingredient	>NDC

nitisinone drug variants not containing TITANIUM DIOXIDE

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Company	Ingredient	NDC
Swedish Orphan Biovitrum AB (publ)	nitisinone	66658-204
Cycle Pharmaceuticals Ltd	nitisinone	70709-002
Eton Pharmaceuticals Inc	nitisinone	71863-119
>Company	>Ingredient	>NDC

Excipient focus: TRISODIUM CITRATE DIHYDRATE

nitisinone drug variants containing TRISODIUM CITRATE DIHYDRATE

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Company	Ingredient	NDC
Swedish Orphan Biovitrum AB (publ)	nitisinone	66658-204
>Company	>Ingredient	>NDC

nitisinone drug variants not containing TRISODIUM CITRATE DIHYDRATE

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Company	Ingredient	NDC
Par Pharmaceutical Inc	nitisinone	0254-3020
Torrent pharmaceuticals limited	nitisinone	13668-629
Bryant Ranch Prepack	nitisinone	63629-2233
>Company	>Ingredient	>NDC

Excipient focus: WATER

nitisinone drug variants containing WATER

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Company	Ingredient	NDC
Swedish Orphan Biovitrum AB (publ)	nitisinone	66658-204
>Company	>Ingredient	>NDC

nitisinone drug variants not containing WATER

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Company	Ingredient	NDC
Par Pharmaceutical Inc	nitisinone	0254-3020
Torrent pharmaceuticals limited	nitisinone	13668-629
Bryant Ranch Prepack	nitisinone	63629-2233
>Company	>Ingredient	>NDC

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