Orange Book product · Brand (NDA)
ISOPTIN
VERAPAMIL HYDROCHLORIDE
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
VERAPAMIL HYDROCHLORIDE
Strength
2.5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 018485
Product number
001
Marketing status
DISCN
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.
- 1998VERELAN PMBrand (NDA)
NDA 020943 · AZURITY
- 1996COVERA-HSBrand (NDA)
NDA 020552 · PFIZER
- 1991CALAN SRBrand (NDA)
NDA 019152 · PFIZER
- 1990VERELANBrand (NDA)
NDA 019614 · AZURITY
- 1988CALANBrand (NDA)
NDA 018817 · PFIZER
- 1987ISOPTINBrand (NDA)
NDA 018593 · MT ADAMS
- 1984CALANBrand (NDA)
NDA 019038 · GD SEARLE LLC
- 1984VERAPAMIL HYDROCHLORIDEBrand (NDA)
NDA 018925 · EXELA PHARMA
- 2025VERAPAMIL HYDROCHLORIDEGeneric (ANDA)
ANDA 219252 · ZYDUS LIFESCIENCES
- 2025VERAPAMIL HYDROCHLORIDEGeneric (ANDA)
ANDA 218218 · ASPIRO
- 2024VERAPAMIL HYDROCHLORIDEGeneric (ANDA)
ANDA 216471 · FRESENIUS KABI USA
- 2022VERAPAMIL HYDROCHLORIDEGeneric (ANDA)
ANDA 206173 · CADILA PHARMS LTD
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.
