Orange Book product · Brand (NDA)
PRONESTYL
PROCAINAMIDE 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
PROCAINAMIDE HYDROCHLORIDE
Strength
500MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 007335
Product number
005
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.
- 2025PROCAINAMIDE HYDROCHLORIDEGeneric (ANDA)
ANDA 218674 · CAPLIN
- 2024PROCAINAMIDE HYDROCHLORIDEGeneric (ANDA)
ANDA 218135 · GLAND
- 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.
