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Astrazeneca Company Profile

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Summary for Applicant: Astrazeneca

Drug Master File Entries: (click here to view)6
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astrazeneca Ab
pramlintide acetate
INJECTABLE;SUBCUTANEOUS021332-003Sep 25, 2007RXYes5,686,411<disabled>YY <disabled>
Astrazeneca Pharms
esomeprazole magnesium
FOR SUSPENSION, DELAYED RELEASE;ORAL021957-003Dec 15, 2011RXNo6,428,810*PED<disabled>Y<disabled>
dyclonine hydrochloride
SOLUTION;TOPICAL009925-001Approved Prior to Jan 1, 1982DISCNNo<disabled><disabled>
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