Application 209869

Type: ANDA
Sponsor: CHARTWELL RX

Related Records

Company: CHARTWELL RX

Application Products

Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	TABLET;ORAL	10MG	No	No
002	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	TABLET;ORAL	20MG	No	No
003	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	TABLET;ORAL	40MG	No	No
004	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	TABLET;ORAL	80MG	No	No

NDC Listings For This Application

NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
55801-141	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	APPCO PHARMA LLC	ANDA	Current
55801-142	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	APPCO PHARMA LLC	ANDA	Current
55801-143	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	APPCO PHARMA LLC	ANDA	Current
55801-144	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	APPCO PHARMA LLC	ANDA	Current
63629-8904	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	ANDA	Current
63629-8904	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	ANDA	Current
63629-8905	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	ANDA	Current
63629-8905	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	ANDA	Current
63629-8906	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	ANDA	Current
63629-8906	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	ANDA	Current
63629-8909	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	ANDA	Current
63629-8909	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	ANDA	Current
63629-8910	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	ANDA	Current
63629-8910	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	ANDA	Current
63629-8911	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	ANDA	Current
63629-8911	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	ANDA	Current
63629-8912	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	ANDA	Current
63629-8912	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	ANDA	Current
63629-8913	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	ANDA	Current
63629-8913	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	ANDA	Current
63629-9162	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	ANDA	Current
63629-9162	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	ANDA	Current
63629-9163	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	ANDA	Current
63629-9163	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	ANDA	Current
63629-9164	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	ANDA	Current
63629-9164	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	ANDA	Current
63629-9165	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	ANDA	Current
63629-9165	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Bryant Ranch Prepack	ANDA	Current
70377-045	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	BIOCON PHARMA INC.,	ANDA	Current
70377-045	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	BIOCON PHARMA INC.,	ANDA	Current
70377-046	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	BIOCON PHARMA INC.,	ANDA	Current
70377-046	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	BIOCON PHARMA INC.,	ANDA	Current
70377-047	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	BIOCON PHARMA INC.,	ANDA	Current
70377-047	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	BIOCON PHARMA INC.,	ANDA	Current
70377-048	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	BIOCON PHARMA INC.,	ANDA	Current
70377-048	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	BIOCON PHARMA INC.,	ANDA	Current

Documents

Document	Title	Submission type	Submission no.	Date	Storage
53693	0	ORIG	1	2018-04-16	Cached in FDA.report object storage