Orange Book product · Brand (NDA)
VERELAN PM
VERAPAMIL HYDROCHLORIDE
At a glance
Nov 25, 1998
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 25, 1998
28 yr ago
Today
Pharmaceutical detail
Active ingredient
VERAPAMIL HYDROCHLORIDE
Strength
300MG
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
TE code
Not listed
Application
NDA 020943
Product number
003
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
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.
- 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
- —ISOPTINBrand (NDA)
NDA 018485 · MT ADAMS
- 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.
