Details for New Drug Application (NDA): 021773

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NDA 021773 describes BYETTA, which is a drug marketed by Astrazeneca Ab and is included in one NDA. It is available from one supplier. Additional details are available on the BYETTA profile page.

The generic ingredient in BYETTA is exenatide synthetic. There are seven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the exenatide synthetic profile page.

Summary for 021773

Tradename:	BYETTA
Applicant:	Astrazeneca Ab
Ingredient:	exenatide synthetic
Patents:	0

Pharmacology for NDA: 021773

Mechanism of Action	Glucagon-like Peptide-1 (GLP-1) Agonists

Suppliers and Packaging for NDA: 021773

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
BYETTA	exenatide synthetic	INJECTABLE;SUBCUTANEOUS	021773	NDA	AstraZeneca Pharmaceuticals LP	0310-6512	0310-6512-01	1 CARTRIDGE in 1 CARTON (0310-6512-01) / 1.2 mL in 1 CARTRIDGE
BYETTA	exenatide synthetic	INJECTABLE;SUBCUTANEOUS	021773	NDA	AstraZeneca Pharmaceuticals LP	0310-6524	0310-6524-01	1 CARTRIDGE in 1 CARTON (0310-6524-01) / 2.4 mL in 1 CARTRIDGE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;SUBCUTANEOUS			Strength	300MCG/1.2ML (250MCG/ML)
Approval Date:	Apr 28, 2005	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	Nov 4, 2024
Regulatory Exclusivity Use:	INFORMATION ADDED TO SECTION 8.4 OF THE LABELING TO DESCRIBE THE RESULTS FROM PEDIATRIC STUDIES

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;SUBCUTANEOUS			Strength	600MCG/2.4ML (250MCG/ML)
Approval Date:	Apr 28, 2005	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	Nov 4, 2024
Regulatory Exclusivity Use:	INFORMATION ADDED TO SECTION 8.4 OF THE LABELING TO DESCRIBE THE RESULTS FROM PEDIATRIC STUDIES

Expired US Patents for NDA 021773

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca Ab	BYETTA	exenatide synthetic	INJECTABLE;SUBCUTANEOUS	021773-002	Apr 28, 2005	⤷ Sign Up	⤷ Sign Up
Astrazeneca Ab	BYETTA	exenatide synthetic	INJECTABLE;SUBCUTANEOUS	021773-002	Apr 28, 2005	⤷ Sign Up	⤷ Sign Up
Astrazeneca Ab	BYETTA	exenatide synthetic	INJECTABLE;SUBCUTANEOUS	021773-002	Apr 28, 2005	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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