← FDA Drug Approvals (Drugs@FDA)
TECZEM
NDA · New Drug Application · Sponsor: BIOVAIL · Approved 1996-10-04
Drug application
- FDA Application #
NDA020507
- Application type
- New Drug Application
- Brand name
- TECZEM
- Generic name
- Diltiazem Malate
- Active ingredients
- DILTIAZEM MALATE; ENALAPRIL MALEATE
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Marketing status
- Discontinued
- Sponsor
- BIOVAIL
- First approval
- 1996-10-04
Source
- Authoritative
- Drugs@FDA application overview
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