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Details for New Drug Application (NDA): 020668

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NDA 020668 describes LEXXEL, which is a drug marketed by Astrazeneca and is included in one NDA. Additional details are available on the LEXXEL profile page.

The generic ingredient in LEXXEL is enalapril maleate; felodipine. There are twenty-seven drug master file entries for this compound. Additional details are available on the enalapril maleate; felodipine profile page.

Summary for NDA: 020668

enalapril maleate; felodipine

Summary for product number 001

Approval Date:Dec 27, 1996TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrength5MG;2.5MG
Approval Date:Oct 28, 1998TE:RLD:No

Expired Orange Book Patents for NDA: 020668

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
enalapril maleate; felodipine
TABLET, EXTENDED RELEASE;ORAL020668-002Oct 28, 19984,803,081*PED<disabled>
enalapril maleate; felodipine
TABLET, EXTENDED RELEASE;ORAL020668-002Oct 28, 19984,264,611*PED<disabled>
enalapril maleate; felodipine
TABLET, EXTENDED RELEASE;ORAL020668-001Dec 27, 19964,472,380<disabled>
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