Orange Book product · Generic (ANDA)
DILTIAZEM HYDROCHLORIDE
DILTIAZEM HYDROCHLORIDE
At a glance
Dec 17, 2008
Approved
Generic (ANDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 17, 2008
17 yr 9 mo ago
Today
Pharmaceutical detail
Active ingredient
DILTIAZEM HYDROCHLORIDE
Strength
5MG/ML
Dosage form
INJECTABLE
Route
INJECTION
TE code
AP
Application
ANDA 078538
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of DILTIAZEM HYDROCHLORIDE
- 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.
