List of Excipients in API saxagliptin and metformin

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Excipients in NDA-approved (novel) drugs containing saxagliptin and metformin

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Company	Tradename	Ingredient	NDC	Excipient	Potential Generic Entry
AstraZeneca Pharmaceuticals LP	KOMBIGLYZE	saxagliptin and metformin hydrochloride	0310-6125	CARBOXYMETHYLCELLULOSE SODIUM
AstraZeneca Pharmaceuticals LP	KOMBIGLYZE	saxagliptin and metformin hydrochloride	0310-6125	HYPROMELLOSE 2208
AstraZeneca Pharmaceuticals LP	KOMBIGLYZE	saxagliptin and metformin hydrochloride	0310-6125	MAGNESIUM STEARATE
>Company	>Tradename	>Ingredient	>NDC	>Excipient	>Potential Generic Entry

Excipients in ANDA-approved (generic) drugs containing saxagliptin and metformin

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Company	Ingredient	NDC	Excipient
Mylan Pharmaceuticals Inc	saxagliptin and metformin	0378-8175	AMMONIA
Mylan Pharmaceuticals Inc	saxagliptin and metformin	0378-8175	CARBOMER HOMOPOLYMER TYPE A
Mylan Pharmaceuticals Inc	saxagliptin and metformin	0378-8175	FERRIC OXIDE RED
Mylan Pharmaceuticals Inc	saxagliptin and metformin	0378-8175	FERROSOFERRIC OXIDE
Mylan Pharmaceuticals Inc	saxagliptin and metformin	0378-8175	HYPROMELLOSE 2208
>Company	>Ingredient	>NDC	>Excipient

Detailed excipient profiles for saxagliptin and metformin

Excipient focus: AMMONIA

saxagliptin and metformin drug variants containing AMMONIA

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Company	Ingredient	NDC
Mylan Pharmaceuticals Inc	saxagliptin and metformin	0378-8175
>Company	>Ingredient	>NDC

saxagliptin and metformin drug variants not containing AMMONIA

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Company	Ingredient	NDC
AstraZeneca Pharmaceuticals LP	saxagliptin and metformin hydrochloride	0310-6125
DrReddys Laboratories Inc	saxagliptin and metformin hydrochloride	43598-620
>Company	>Ingredient	>NDC

Excipient focus: CARBOMER HOMOPOLYMER TYPE A

saxagliptin and metformin drug variants containing CARBOMER HOMOPOLYMER TYPE A

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Company	Ingredient	NDC
Mylan Pharmaceuticals Inc	saxagliptin and metformin	0378-8175
>Company	>Ingredient	>NDC

saxagliptin and metformin drug variants not containing CARBOMER HOMOPOLYMER TYPE A

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Company	Ingredient	NDC
AstraZeneca Pharmaceuticals LP	saxagliptin and metformin hydrochloride	0310-6125
DrReddys Laboratories Inc	saxagliptin and metformin hydrochloride	43598-620
>Company	>Ingredient	>NDC

Excipient focus: CARBOXYMETHYLCELLULOSE SODIUM

saxagliptin and metformin drug variants containing CARBOXYMETHYLCELLULOSE SODIUM

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Company	Ingredient	NDC
AstraZeneca Pharmaceuticals LP	saxagliptin and metformin hydrochloride	0310-6125
>Company	>Ingredient	>NDC

saxagliptin and metformin drug variants not containing CARBOXYMETHYLCELLULOSE SODIUM

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Company	Ingredient	NDC
Mylan Pharmaceuticals Inc	saxagliptin and metformin	0378-8175
DrReddys Laboratories Inc	saxagliptin and metformin hydrochloride	43598-620
>Company	>Ingredient	>NDC

Excipient focus: CELLULOSE, MICROCRYSTALLINE

saxagliptin and metformin drug variants containing CELLULOSE, MICROCRYSTALLINE

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Company	Ingredient	NDC
DrReddys Laboratories Inc	saxagliptin and metformin hydrochloride	43598-620
>Company	>Ingredient	>NDC

saxagliptin and metformin drug variants not containing CELLULOSE, MICROCRYSTALLINE

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Company	Ingredient	NDC
Mylan Pharmaceuticals Inc	saxagliptin and metformin	0378-8175
AstraZeneca Pharmaceuticals LP	saxagliptin and metformin hydrochloride	0310-6125
>Company	>Ingredient	>NDC

Excipient focus: FERRIC OXIDE RED

saxagliptin and metformin drug variants containing FERRIC OXIDE RED

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Company	Ingredient	NDC
Mylan Pharmaceuticals Inc	saxagliptin and metformin	0378-8175
DrReddys Laboratories Inc	saxagliptin and metformin hydrochloride	43598-620
>Company	>Ingredient	>NDC

saxagliptin and metformin drug variants not containing FERRIC OXIDE RED

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Company	Ingredient	NDC
AstraZeneca Pharmaceuticals LP	saxagliptin and metformin hydrochloride	0310-6125
>Company	>Ingredient	>NDC

Excipient focus: FERRIC OXIDE YELLOW

saxagliptin and metformin drug variants containing FERRIC OXIDE YELLOW

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Company	Ingredient	NDC
DrReddys Laboratories Inc	saxagliptin and metformin hydrochloride	43598-620
>Company	>Ingredient	>NDC

saxagliptin and metformin drug variants not containing FERRIC OXIDE YELLOW

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Company	Ingredient	NDC
Mylan Pharmaceuticals Inc	saxagliptin and metformin	0378-8175
AstraZeneca Pharmaceuticals LP	saxagliptin and metformin hydrochloride	0310-6125
>Company	>Ingredient	>NDC

Excipient focus: FERROSOFERRIC OXIDE

saxagliptin and metformin drug variants containing FERROSOFERRIC OXIDE

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Company	Ingredient	NDC
Mylan Pharmaceuticals Inc	saxagliptin and metformin	0378-8175
DrReddys Laboratories Inc	saxagliptin and metformin hydrochloride	43598-620
>Company	>Ingredient	>NDC

saxagliptin and metformin drug variants not containing FERROSOFERRIC OXIDE

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Company	Ingredient	NDC
AstraZeneca Pharmaceuticals LP	saxagliptin and metformin hydrochloride	0310-6125
>Company	>Ingredient	>NDC

Excipient focus: HYDROCHLORIC ACID

saxagliptin and metformin drug variants containing HYDROCHLORIC ACID

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Company	Ingredient	NDC
DrReddys Laboratories Inc	saxagliptin and metformin hydrochloride	43598-620
>Company	>Ingredient	>NDC

saxagliptin and metformin drug variants not containing HYDROCHLORIC ACID

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Company	Ingredient	NDC
Mylan Pharmaceuticals Inc	saxagliptin and metformin	0378-8175
AstraZeneca Pharmaceuticals LP	saxagliptin and metformin hydrochloride	0310-6125
>Company	>Ingredient	>NDC

Excipient focus: HYPROMELLOSE 2208

saxagliptin and metformin drug variants containing HYPROMELLOSE 2208

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Company	Ingredient	NDC
Mylan Pharmaceuticals Inc	saxagliptin and metformin	0378-8175
AstraZeneca Pharmaceuticals LP	saxagliptin and metformin hydrochloride	0310-6125
DrReddys Laboratories Inc	saxagliptin and metformin hydrochloride	43598-620
>Company	>Ingredient	>NDC

saxagliptin and metformin drug variants not containing HYPROMELLOSE 2208

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Company	Ingredient	NDC
>Company	>Ingredient	>NDC

Excipient focus: HYPROMELLOSE 2910

saxagliptin and metformin drug variants containing HYPROMELLOSE 2910

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Company	Ingredient	NDC
DrReddys Laboratories Inc	saxagliptin and metformin hydrochloride	43598-620
>Company	>Ingredient	>NDC

saxagliptin and metformin drug variants not containing HYPROMELLOSE 2910

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Company	Ingredient	NDC
Mylan Pharmaceuticals Inc	saxagliptin and metformin	0378-8175
AstraZeneca Pharmaceuticals LP	saxagliptin and metformin hydrochloride	0310-6125
>Company	>Ingredient	>NDC

Excipient focus: MAGNESIUM STEARATE

saxagliptin and metformin drug variants containing MAGNESIUM STEARATE

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Company	Ingredient	NDC
Mylan Pharmaceuticals Inc	saxagliptin and metformin	0378-8175
AstraZeneca Pharmaceuticals LP	saxagliptin and metformin hydrochloride	0310-6125
DrReddys Laboratories Inc	saxagliptin and metformin hydrochloride	43598-620
>Company	>Ingredient	>NDC

saxagliptin and metformin drug variants not containing MAGNESIUM STEARATE

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Company	Ingredient	NDC
>Company	>Ingredient	>NDC

Excipient focus: POLYETHYLENE GLYCOL 3350

saxagliptin and metformin drug variants containing POLYETHYLENE GLYCOL 3350

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Company	Ingredient	NDC
Mylan Pharmaceuticals Inc	saxagliptin and metformin	0378-8175
DrReddys Laboratories Inc	saxagliptin and metformin hydrochloride	43598-620
>Company	>Ingredient	>NDC

saxagliptin and metformin drug variants not containing POLYETHYLENE GLYCOL 3350

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Company	Ingredient	NDC
AstraZeneca Pharmaceuticals LP	saxagliptin and metformin hydrochloride	0310-6125
>Company	>Ingredient	>NDC

Excipient focus: POLYETHYLENE GLYCOL 400

saxagliptin and metformin drug variants containing POLYETHYLENE GLYCOL 400

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Company	Ingredient	NDC
DrReddys Laboratories Inc	saxagliptin and metformin hydrochloride	43598-620
>Company	>Ingredient	>NDC

saxagliptin and metformin drug variants not containing POLYETHYLENE GLYCOL 400

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Company	Ingredient	NDC
Mylan Pharmaceuticals Inc	saxagliptin and metformin	0378-8175
AstraZeneca Pharmaceuticals LP	saxagliptin and metformin hydrochloride	0310-6125
>Company	>Ingredient	>NDC

Excipient focus: POLYETHYLENE GLYCOL 4000

saxagliptin and metformin drug variants containing POLYETHYLENE GLYCOL 4000

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Company	Ingredient	NDC
DrReddys Laboratories Inc	saxagliptin and metformin hydrochloride	43598-620
>Company	>Ingredient	>NDC

saxagliptin and metformin drug variants not containing POLYETHYLENE GLYCOL 4000

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Company	Ingredient	NDC
Mylan Pharmaceuticals Inc	saxagliptin and metformin	0378-8175
AstraZeneca Pharmaceuticals LP	saxagliptin and metformin hydrochloride	0310-6125
>Company	>Ingredient	>NDC

Excipient focus: POLYETHYLENE GLYCOL 8000

saxagliptin and metformin drug variants containing POLYETHYLENE GLYCOL 8000

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Company	Ingredient	NDC
DrReddys Laboratories Inc	saxagliptin and metformin hydrochloride	43598-620
>Company	>Ingredient	>NDC

saxagliptin and metformin drug variants not containing POLYETHYLENE GLYCOL 8000

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Company	Ingredient	NDC
Mylan Pharmaceuticals Inc	saxagliptin and metformin	0378-8175
AstraZeneca Pharmaceuticals LP	saxagliptin and metformin hydrochloride	0310-6125
>Company	>Ingredient	>NDC

Excipient focus: POLYVINYL ALCOHOL

saxagliptin and metformin drug variants containing POLYVINYL ALCOHOL

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Company	Ingredient	NDC
Mylan Pharmaceuticals Inc	saxagliptin and metformin	0378-8175
>Company	>Ingredient	>NDC

saxagliptin and metformin drug variants not containing POLYVINYL ALCOHOL

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Company	Ingredient	NDC
AstraZeneca Pharmaceuticals LP	saxagliptin and metformin hydrochloride	0310-6125
DrReddys Laboratories Inc	saxagliptin and metformin hydrochloride	43598-620
>Company	>Ingredient	>NDC

Excipient focus: POVIDONE K30

saxagliptin and metformin drug variants containing POVIDONE K30

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Company	Ingredient	NDC
DrReddys Laboratories Inc	saxagliptin and metformin hydrochloride	43598-620
>Company	>Ingredient	>NDC

saxagliptin and metformin drug variants not containing POVIDONE K30

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Company	Ingredient	NDC
Mylan Pharmaceuticals Inc	saxagliptin and metformin	0378-8175
AstraZeneca Pharmaceuticals LP	saxagliptin and metformin hydrochloride	0310-6125
>Company	>Ingredient	>NDC

Excipient focus: POVIDONE K90

saxagliptin and metformin drug variants containing POVIDONE K90

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Company	Ingredient	NDC
Mylan Pharmaceuticals Inc	saxagliptin and metformin	0378-8175
DrReddys Laboratories Inc	saxagliptin and metformin hydrochloride	43598-620
>Company	>Ingredient	>NDC

saxagliptin and metformin drug variants not containing POVIDONE K90

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Company	Ingredient	NDC
AstraZeneca Pharmaceuticals LP	saxagliptin and metformin hydrochloride	0310-6125
>Company	>Ingredient	>NDC

Excipient focus: PROPYLENE GLYCOL

saxagliptin and metformin drug variants containing PROPYLENE GLYCOL

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Company	Ingredient	NDC
Mylan Pharmaceuticals Inc	saxagliptin and metformin	0378-8175
DrReddys Laboratories Inc	saxagliptin and metformin hydrochloride	43598-620
>Company	>Ingredient	>NDC

saxagliptin and metformin drug variants not containing PROPYLENE GLYCOL

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Company	Ingredient	NDC
AstraZeneca Pharmaceuticals LP	saxagliptin and metformin hydrochloride	0310-6125
>Company	>Ingredient	>NDC

Excipient focus: SHELLAC

saxagliptin and metformin drug variants containing SHELLAC

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Company	Ingredient	NDC
Mylan Pharmaceuticals Inc	saxagliptin and metformin	0378-8175
DrReddys Laboratories Inc	saxagliptin and metformin hydrochloride	43598-620
>Company	>Ingredient	>NDC

saxagliptin and metformin drug variants not containing SHELLAC

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Company	Ingredient	NDC
AstraZeneca Pharmaceuticals LP	saxagliptin and metformin hydrochloride	0310-6125
>Company	>Ingredient	>NDC

Excipient focus: SILICON DIOXIDE

saxagliptin and metformin drug variants containing SILICON DIOXIDE

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Company	Ingredient	NDC
Mylan Pharmaceuticals Inc	saxagliptin and metformin	0378-8175
DrReddys Laboratories Inc	saxagliptin and metformin hydrochloride	43598-620
>Company	>Ingredient	>NDC

saxagliptin and metformin drug variants not containing SILICON DIOXIDE

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Company	Ingredient	NDC
AstraZeneca Pharmaceuticals LP	saxagliptin and metformin hydrochloride	0310-6125
>Company	>Ingredient	>NDC

Excipient focus: STEARIC ACID

saxagliptin and metformin drug variants containing STEARIC ACID

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Company	Ingredient	NDC
Mylan Pharmaceuticals Inc	saxagliptin and metformin	0378-8175
>Company	>Ingredient	>NDC

saxagliptin and metformin drug variants not containing STEARIC ACID

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Company	Ingredient	NDC
AstraZeneca Pharmaceuticals LP	saxagliptin and metformin hydrochloride	0310-6125
DrReddys Laboratories Inc	saxagliptin and metformin hydrochloride	43598-620
>Company	>Ingredient	>NDC

Excipient focus: TALC

saxagliptin and metformin drug variants containing TALC

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Company	Ingredient	NDC
Mylan Pharmaceuticals Inc	saxagliptin and metformin	0378-8175
DrReddys Laboratories Inc	saxagliptin and metformin hydrochloride	43598-620
>Company	>Ingredient	>NDC

saxagliptin and metformin drug variants not containing TALC

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Company	Ingredient	NDC
AstraZeneca Pharmaceuticals LP	saxagliptin and metformin hydrochloride	0310-6125
>Company	>Ingredient	>NDC

Excipient focus: TITANIUM DIOXIDE

saxagliptin and metformin drug variants containing TITANIUM DIOXIDE

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Company	Ingredient	NDC
Mylan Pharmaceuticals Inc	saxagliptin and metformin	0378-8175
DrReddys Laboratories Inc	saxagliptin and metformin hydrochloride	43598-620
>Company	>Ingredient	>NDC

saxagliptin and metformin drug variants not containing TITANIUM DIOXIDE

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Company	Ingredient	NDC
AstraZeneca Pharmaceuticals LP	saxagliptin and metformin hydrochloride	0310-6125
>Company	>Ingredient	>NDC

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