Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020507
Company: BIOVAIL
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 |