Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020507
Company: BIOVAIL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TECZEM DILTIAZEM MALATE; ENALAPRIL MALEATE EQ 180MG HYDROCHLORIDE;5MG TABLET, EXTENDED RELEASE;ORAL Discontinued None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
10/04/1996 ORIG-1 Approval Type 2 New Active Ingredient and Type 4 New Combination STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/04/2002 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

03/03/2000 SUPPL-2 Labeling

Label is not available on this site.

02/17/1999 SUPPL-1 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20507-s001_Teczem.pdf

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