List of Excipients in API amikacin

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Excipients in NDA-approved (novel) drugs containing amikacin

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Company	Tradename	Ingredient	NDC	Excipient	Potential Generic Entry
Insmed Incorporated	ARIKAYCE	amikacin	71558-590	CHOLESTEROL
Insmed Incorporated	ARIKAYCE	amikacin	71558-590	DIPALMITOYLPHOSPHATIDYLCHOLINE, DL-
Insmed Incorporated	ARIKAYCE	amikacin	71558-590	SODIUM CHLORIDE
>Company	>Tradename	>Ingredient	>NDC	>Excipient	>Potential Generic Entry

Excipients in ANDA-approved (generic) drugs containing amikacin

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Company	Ingredient	NDC	Excipient
Hikma Pharmaceuticals USA Inc	amikacin sulfate	0641-6166	SODIUM CITRATE
Hikma Pharmaceuticals USA Inc	amikacin sulfate	0641-6166	SODIUM METABISULFITE
Hikma Pharmaceuticals USA Inc	amikacin sulfate	0641-6166	SULFURIC ACID
>Company	>Ingredient	>NDC	>Excipient

Detailed excipient profiles for amikacin

Excipient focus: CHOLESTEROL

amikacin drug variants containing CHOLESTEROL

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Company	Ingredient	NDC
Insmed Incorporated	amikacin	71558-590
>Company	>Ingredient	>NDC

amikacin drug variants not containing CHOLESTEROL

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Company	Ingredient	NDC
Hikma Pharmaceuticals USA Inc	amikacin sulfate	0641-6166
Teva Parenteral Medicines Inc	amikacin sulfate	0703-9032
Heritage Pharmaceuticals Inc d/b/a Avet Pharmaceuticals Inc	amikacin sulfate	23155-290
>Company	>Ingredient	>NDC

Excipient focus: DIPALMITOYLPHOSPHATIDYLCHOLINE, DL-

amikacin drug variants containing DIPALMITOYLPHOSPHATIDYLCHOLINE, DL-

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Company	Ingredient	NDC
Insmed Incorporated	amikacin	71558-590
>Company	>Ingredient	>NDC

amikacin drug variants not containing DIPALMITOYLPHOSPHATIDYLCHOLINE, DL-

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Company	Ingredient	NDC
Hikma Pharmaceuticals USA Inc	amikacin sulfate	0641-6166
Teva Parenteral Medicines Inc	amikacin sulfate	0703-9032
Heritage Pharmaceuticals Inc d/b/a Avet Pharmaceuticals Inc	amikacin sulfate	23155-290
>Company	>Ingredient	>NDC

Excipient focus: SODIUM CHLORIDE

amikacin drug variants containing SODIUM CHLORIDE

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Company	Ingredient	NDC
Insmed Incorporated	amikacin	71558-590
>Company	>Ingredient	>NDC

amikacin drug variants not containing SODIUM CHLORIDE

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Company	Ingredient	NDC
Hikma Pharmaceuticals USA Inc	amikacin sulfate	0641-6166
Teva Parenteral Medicines Inc	amikacin sulfate	0703-9032
Heritage Pharmaceuticals Inc d/b/a Avet Pharmaceuticals Inc	amikacin sulfate	23155-290
>Company	>Ingredient	>NDC

Excipient focus: SODIUM CITRATE

amikacin drug variants containing SODIUM CITRATE

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Company	Ingredient	NDC
Hikma Pharmaceuticals USA Inc	amikacin sulfate	0641-6166
Heritage Pharmaceuticals Inc d/b/a Avet Pharmaceuticals Inc	amikacin sulfate	23155-290
Heritage Pharmaceuticals Inc d/b/a Avet Pharmaceuticals Inc	amikacin sulfate	23155-785
>Company	>Ingredient	>NDC

amikacin drug variants not containing SODIUM CITRATE

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Company	Ingredient	NDC
Insmed Incorporated	amikacin	71558-590
Teva Parenteral Medicines Inc	amikacin sulfate	0703-9032
Sagent Pharmaceuticals	amikacin sulfate	25021-173
>Company	>Ingredient	>NDC

Excipient focus: SODIUM HYDROXIDE

amikacin drug variants containing SODIUM HYDROXIDE

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Company	Ingredient	NDC
Insmed Incorporated	amikacin	71558-590
Teva Parenteral Medicines Inc	amikacin sulfate	0703-9032
>Company	>Ingredient	>NDC

amikacin drug variants not containing SODIUM HYDROXIDE

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Company	Ingredient	NDC
Hikma Pharmaceuticals USA Inc	amikacin sulfate	0641-6166
Heritage Pharmaceuticals Inc d/b/a Avet Pharmaceuticals Inc	amikacin sulfate	23155-290
Heritage Pharmaceuticals Inc d/b/a Avet Pharmaceuticals Inc	amikacin sulfate	23155-785
>Company	>Ingredient	>NDC

Excipient focus: SODIUM METABISULFITE

amikacin drug variants containing SODIUM METABISULFITE

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Company	Ingredient	NDC
Hikma Pharmaceuticals USA Inc	amikacin sulfate	0641-6166
Teva Parenteral Medicines Inc	amikacin sulfate	0703-9032
Heritage Pharmaceuticals Inc d/b/a Avet Pharmaceuticals Inc	amikacin sulfate	23155-290
>Company	>Ingredient	>NDC

amikacin drug variants not containing SODIUM METABISULFITE

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Company	Ingredient	NDC
Insmed Incorporated	amikacin	71558-590
>Company	>Ingredient	>NDC

Excipient focus: SULFURIC ACID

amikacin drug variants containing SULFURIC ACID

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Company	Ingredient	NDC
Hikma Pharmaceuticals USA Inc	amikacin sulfate	0641-6166
Teva Parenteral Medicines Inc	amikacin sulfate	0703-9032
Heritage Pharmaceuticals Inc d/b/a Avet Pharmaceuticals Inc	amikacin sulfate	23155-290
>Company	>Ingredient	>NDC

amikacin drug variants not containing SULFURIC ACID

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Company	Ingredient	NDC
Insmed Incorporated	amikacin	71558-590
>Company	>Ingredient	>NDC

Excipient focus: TRISODIUM CITRATE DIHYDRATE

amikacin drug variants containing TRISODIUM CITRATE DIHYDRATE

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Company	Ingredient	NDC
Teva Parenteral Medicines Inc	amikacin sulfate	0703-9032
Sagent Pharmaceuticals	amikacin sulfate	25021-173
Fresenius Kabi USA LLC	amikacin sulfate	63323-815
>Company	>Ingredient	>NDC

amikacin drug variants not containing TRISODIUM CITRATE DIHYDRATE

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Company	Ingredient	NDC
Insmed Incorporated	amikacin	71558-590
Hikma Pharmaceuticals USA Inc	amikacin sulfate	0641-6166
Heritage Pharmaceuticals Inc d/b/a Avet Pharmaceuticals Inc	amikacin sulfate	23155-290
>Company	>Ingredient	>NDC

Excipient focus: WATER

amikacin drug variants containing WATER

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Company	Ingredient	NDC
Insmed Incorporated	amikacin	71558-590
Hikma Pharmaceuticals USA Inc	amikacin sulfate	0641-6166
Teva Parenteral Medicines Inc	amikacin sulfate	0703-9032
>Company	>Ingredient	>NDC

amikacin drug variants not containing WATER

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Company	Ingredient	NDC
Heritage Pharmaceuticals Inc d/b/a Avet Pharmaceuticals Inc	amikacin sulfate	23155-290
Heritage Pharmaceuticals Inc d/b/a Avet Pharmaceuticals Inc	amikacin sulfate	23155-785
Sagent Pharmaceuticals	amikacin sulfate	25021-173
>Company	>Ingredient	>NDC

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