Orange Book product · Brand (NDA)
CARDIZEM
DILTIAZEM HYDROCHLORIDE
At a glance
Sep 05, 1997
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 05, 1997
29 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
DILTIAZEM HYDROCHLORIDE
Strength
100MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
NDA 020792
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a brand (NDA) product. Other products sharing this active ingredient are listed below.
- 2000DILTIAZEM HYDROCHLORIDEBrand (NDA)
NDA 020939 · BIOVAIL
- 1995TIAZACBrand (NDA)
NDA 020401 · BAUSCH
- 1992CARDIZEM CDBrand (NDA)
NDA 020062 · BAUSCH
- 1992DILACOR XRBrand (NDA)
NDA 020092 · ALLERGAN
- 1991CARDIZEMBrand (NDA)
NDA 020027 · BIOVAIL LABS INTL
- 1989CARDIZEM SRBrand (NDA)
NDA 019471 · BIOVAIL
- 2026DILTIAZEM HYDROCHLORIDEGeneric (ANDA)
ANDA 218744 · MACLEODS PHARMS LTD
- 2025DILTIAZEM HYDROCHLORIDEGeneric (ANDA)
ANDA 218032 · NOVAST LABS
- 2025DILTIAZEM HYDROCHLORIDEGeneric (ANDA)
ANDA 219073 · UTOPIC PHARMS
- 2024DILTIAZEM HYDROCHLORIDEGeneric (ANDA)
ANDA 216968 · ALEMBIC
- 2024DILTIAZEM HYDROCHLORIDEGeneric (ANDA)
ANDA 218587 · ALEMBIC
- 2023DILTIAZEM HYDROCHLORIDEGeneric (ANDA)
ANDA 216552 · EUGIA PHARMA
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
