Orange Book product · Generic (ANDA)
PROCAINAMIDE HYDROCHLORIDE
PROCAINAMIDE HYDROCHLORIDE
At a glance
Jul 22, 2024
Approved
Generic (ANDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 22, 2024
1 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
PROCAINAMIDE HYDROCHLORIDE
Strength
500MG/ML
Dosage form
INJECTABLE
Route
INJECTION
TE code
AP
Application
ANDA 218135
Product number
002
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
Yes
Active-ingredient family
View full familyGeneric (ANDA) of PROCAINAMIDE HYDROCHLORIDE
- —PRONESTYLBrand (NDA)
NDA 007335 · APOTHECON
- 2025PROCAINAMIDE HYDROCHLORIDEGeneric (ANDA)
ANDA 218674 · CAPLIN
- 2017PROCAINAMIDE HYDROCHLORIDEGeneric (ANDA)
ANDA 206332 · NEXUS
- 1996PROCAINAMIDE HYDROCHLORIDEGeneric (ANDA)
ANDA 040111 · ANI PHARMS
- 1988PROCAINAMIDE HYDROCHLORIDEGeneric (ANDA)
ANDA 089528 · WARNER CHILCOTT
- 1988PROCAINAMIDE HYDROCHLORIDEGeneric (ANDA)
ANDA 089529 · WARNER CHILCOTT
- 1987PROCAINAMIDE HYDROCHLORIDEGeneric (ANDA)
ANDA 089537 · HOSPIRA
- 1986PROCAINAMIDE HYDROCHLORIDEGeneric (ANDA)
ANDA 089415 · ABRAXIS PHARM
- 1986PROCAINAMIDE HYDROCHLORIDEGeneric (ANDA)
ANDA 089416 · ABRAXIS PHARM
- 1986PROCAINAMIDE HYDROCHLORIDEGeneric (ANDA)
ANDA 089219 · ANI PHARMS
- 1986PROCAINAMIDE HYDROCHLORIDEGeneric (ANDA)
ANDA 089029 · HIKMA
- 1986PROCAINAMIDE HYDROCHLORIDEGeneric (ANDA)
ANDA 089030 · WEST-WARD PHARMS INT
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.
