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Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astrazeneca Ab
BYDUREON
exenatide synthetic
FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS022200-001Jan 27, 2012RXYes6,824,822<disabled>Y <disabled>
Aurobindo Pharma Ltd
BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE
bupivacaine hydrochloride
INJECTABLE;INJECTION203895-003Nov 5, 2013RXNo<disabled><disabled>
Zydus Pharms Usa Inc
BUSPIRONE HYDROCHLORIDE
buspirone hydrochloride
TABLET;ORAL078888-001Feb 7, 2014RXNo<disabled><disabled>
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