Details for New Drug Application (NDA): 020507

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NDA 020507 describes TECZEM, which is a drug marketed by Biovail and is included in one NDA. Additional details are available on the TECZEM profile page.

The generic ingredient in TECZEM is diltiazem malate; enalapril maleate. There are twenty-six drug master file entries for this compound. Additional details are available on the diltiazem malate; enalapril maleate profile page.

Summary for 020507

Tradename:	TECZEM
Applicant:	Biovail
Ingredient:	diltiazem malate; enalapril maleate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	EQ 180MG HYDROCHLORIDE;5MG
Approval Date:	Oct 4, 1996	TE:		RLD:	No

Expired US Patents for NDA 020507

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Biovail	TECZEM	diltiazem malate; enalapril maleate	TABLET, EXTENDED RELEASE;ORAL	020507-001	Oct 4, 1996	⤷ Sign Up	⤷ Sign Up
Biovail	TECZEM	diltiazem malate; enalapril maleate	TABLET, EXTENDED RELEASE;ORAL	020507-001	Oct 4, 1996	⤷ Sign Up	⤷ Sign Up
Biovail	TECZEM	diltiazem malate; enalapril maleate	TABLET, EXTENDED RELEASE;ORAL	020507-001	Oct 4, 1996	⤷ Sign Up	⤷ Sign Up
Biovail	TECZEM	diltiazem malate; enalapril maleate	TABLET, EXTENDED RELEASE;ORAL	020507-001	Oct 4, 1996	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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