Orange Book product · Brand (NDA)
CARDIZEM LA
DILTIAZEM HYDROCHLORIDE
At a glance
Feb 06, 2003
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 06, 2003
23 yr 8 mo ago
Today
Pharmaceutical detail
Active ingredient
DILTIAZEM HYDROCHLORIDE
Strength
120MG
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
TE code
AB
Application
NDA 021392
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2000DILTIAZEM HYDROCHLORIDEBrand (NDA)
NDA 020939 · BIOVAIL
- 1997CARDIZEMBrand (NDA)
NDA 020792 · 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
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.
