Details for New Drug Application (NDA): 021929

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NDA 021929 describes SYMBICORT, which is a drug marketed by Astrazeneca and is included in two NDAs. It is available from three suppliers. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the SYMBICORT profile page.

The generic ingredient in SYMBICORT is budesonide; formoterol fumarate. There are twenty-two drug master file entries for this compound. Additional details are available on the budesonide; formoterol fumarate profile page.

Summary for 021929

Tradename:	SYMBICORT
Applicant:	Astrazeneca
Ingredient:	budesonide; formoterol fumarate dihydrate
Patents:	0

Pharmacology for NDA: 021929

Mechanism of Action	Adrenergic beta2-Agonists Corticosteroid Hormone Receptor Agonists

Suppliers and Packaging for NDA: 021929

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SYMBICORT	budesonide; formoterol fumarate dihydrate	AEROSOL, METERED;INHALATION	021929	NDA	AstraZeneca Pharmaceuticals LP	0186-0370	0186-0370-20	1 POUCH in 1 CARTON (0186-0370-20) / 1 CANISTER in 1 POUCH / 120 AEROSOL in 1 CANISTER
SYMBICORT	budesonide; formoterol fumarate dihydrate	AEROSOL, METERED;INHALATION	021929	NDA	AstraZeneca Pharmaceuticals LP	0186-0370	0186-0370-28	1 POUCH in 1 CARTON (0186-0370-28) / 1 CANISTER in 1 POUCH / 60 AEROSOL in 1 CANISTER

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	AEROSOL, METERED;INHALATION			Strength	0.08MG/INH;0.0045MG/INH
Approval Date:	Jul 21, 2006	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	AEROSOL, METERED;INHALATION			Strength	0.16MG/INH;0.0045MG/INH
Approval Date:	Jul 21, 2006	TE:	AB	RLD:	Yes

Expired US Patents for NDA 021929

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca	SYMBICORT	budesonide; formoterol fumarate dihydrate	AEROSOL, METERED;INHALATION	021929-002	Jul 21, 2006	⤷ Get Started Free	⤷ Get Started Free
Astrazeneca	SYMBICORT	budesonide; formoterol fumarate dihydrate	AEROSOL, METERED;INHALATION	021929-002	Jul 21, 2006	⤷ Get Started Free	⤷ Get Started Free
Astrazeneca	SYMBICORT	budesonide; formoterol fumarate dihydrate	AEROSOL, METERED;INHALATION	021929-001	Jul 21, 2006	⤷ Get Started Free	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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