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Generated: April 25, 2019

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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. There are two patents protecting this drug and one Paragraph IV challenge. 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:2
Formulation / Manufacturing:see details
Pharmacology for NDA: 021773
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:RXDosage:INJECTABLE;SUBCUTANEOUSStrength300MCG/1.2ML (250MCG/ML)
Approval Date:Apr 28, 2005TE:RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Jan 14, 2020Product Flag?Substance Flag?Delist Request?
Patented Use:LOWERING PLASMA GLUCAGON IN A SUBJECT IN NEED THEREOF, INCLUDING ONE WITH TYPE 2 DIABETES, BY ADMINISTERING AN EXENDIN OR ANALOG, SUCH AS EXENDIN-4
Patent:➤ Try a Free TrialPatent Expiration:Jan 14, 2020Product Flag?YSubstance Flag?Delist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;SUBCUTANEOUSStrength600MCG/2.4ML (250MCG/ML)
Approval Date:Apr 28, 2005TE:RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Jan 14, 2020Product Flag?Substance Flag?Delist Request?
Patented Use:LOWERING PLASMA GLUCAGON IN A SUBJECT IN NEED THEREOF, INCLUDING ONE WITH TYPE 2 DIABETES, BY ADMINISTERING AN EXENDIN OR ANALOG, SUCH AS EXENDIN-4

Expired US Patents for NDA 021773

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca Ab BYETTA exenatide synthetic INJECTABLE;SUBCUTANEOUS 021773-001 Apr 28, 2005 ➤ Try a Free Trial ➤ Try a Free Trial
Astrazeneca Ab BYETTA exenatide synthetic INJECTABLE;SUBCUTANEOUS 021773-002 Apr 28, 2005 ➤ Try a Free Trial ➤ Try a Free Trial
Astrazeneca Ab BYETTA exenatide synthetic INJECTABLE;SUBCUTANEOUS 021773-001 Apr 28, 2005 ➤ Try a Free Trial ➤ Try a Free Trial
Astrazeneca Ab BYETTA exenatide synthetic INJECTABLE;SUBCUTANEOUS 021773-001 Apr 28, 2005 ➤ Try a Free Trial ➤ Try a Free Trial
Astrazeneca Ab BYETTA exenatide synthetic INJECTABLE;SUBCUTANEOUS 021773-001 Apr 28, 2005 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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