Application 076341

Type: ANDA
Sponsor: APOTEX

Related Records

Company: APOTEX

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
0904-5891	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Major Pharmaceuticals	ANDA	Current
0904-5891	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Major Pharmaceuticals	ANDA	Current
0904-5891	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Major Pharmaceuticals	ANDA	Current
0904-5892	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Major Pharmaceuticals	ANDA	Current
0904-5892	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Major Pharmaceuticals	ANDA	Current
0904-5892	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Major Pharmaceuticals	ANDA	Current
0904-5893	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Major Pharmaceuticals	ANDA	Current
0904-5893	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Major Pharmaceuticals	ANDA	Current
0904-5893	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Major Pharmaceuticals	ANDA	Current
35356-125	Pravastatin Sodium	pravastatin sodium	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
35356-125	Pravastatin Sodium	pravastatin sodium	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
35356-125	Pravastatin Sodium	pravastatin sodium	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
35356-125	Pravastatin Sodium	pravastatin sodium	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
35356-125	Pravastatin Sodium	pravastatin sodium	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
35356-125	Pravastatin Sodium	pravastatin sodium	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
35356-919	Pravastatin Sodium	pravastatin sodium	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
35356-919	Pravastatin Sodium	pravastatin sodium	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
35356-919	Pravastatin Sodium	pravastatin sodium	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
35356-919	Pravastatin Sodium	pravastatin sodium	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
35356-919	Pravastatin Sodium	pravastatin sodium	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
35356-919	Pravastatin Sodium	pravastatin sodium	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
35356-921	Pravastatin Sodium	pravastatin sodium	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
35356-921	Pravastatin Sodium	pravastatin sodium	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
35356-921	Pravastatin Sodium	pravastatin sodium	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
35356-921	Pravastatin Sodium	pravastatin sodium	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
35356-921	Pravastatin Sodium	pravastatin sodium	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
35356-921	Pravastatin Sodium	pravastatin sodium	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
43353-474	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Aphena Pharma Solutions - Tennessee, Inc.	ANDA	Current
50090-2024	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	A-S Medication Solutions	ANDA	Current
50090-2024	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	A-S Medication Solutions	ANDA	Current
50090-2025	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	A-S Medication Solutions	ANDA	Current
50090-2025	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	A-S Medication Solutions	ANDA	Current
50090-2025	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	A-S Medication Solutions	ANDA	Current
50090-3204	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	A-S Medication Solutions	ANDA	Current
50090-3204	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	A-S Medication Solutions	ANDA	Current
50090-3204	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	A-S Medication Solutions	ANDA	Current
50090-3853	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	A-S Medication Solutions	ANDA	Current
50090-3853	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	A-S Medication Solutions	ANDA	Current
50090-3853	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	A-S Medication Solutions	ANDA	Current
50268-665	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	AvPAK	ANDA	Current
50268-665	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	AvPAK	ANDA	Current
50268-665	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	AvPAK	ANDA	Current
50268-665	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	AvPAK	ANDA	Current
50268-666	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	AvPAK	ANDA	Current
50268-666	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	AvPAK	ANDA	Current
50268-666	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	AvPAK	ANDA	Current
50268-666	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	AvPAK	ANDA	Current
50268-667	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	AvPAK	ANDA	Current
50268-667	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	AvPAK	ANDA	Current
50268-667	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	AvPAK	ANDA	Current
50268-667	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	AvPAK	ANDA	Current
50268-668	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	AvPAK	ANDA	Current
50268-668	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	AvPAK	ANDA	Current
50268-668	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	AvPAK	ANDA	Current
50268-668	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	AvPAK	ANDA	Current
50436-3800	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Unit Dose Services	ANDA	Current
50436-6617	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Unit Dose Services	ANDA	Current
51655-976	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Northwind Pharmaceuticals	ANDA	Current
53217-379	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Aidarex Pharmaceuticals LLC	ANDA	Current
53808-0536	Pravastatin Sodium	Pravastatin Sodium	State of Florida DOH Central Pharmacy	ANDA	Current
53808-0538	Pravastatin Sodium	Pravastatin Sodium	State of Florida DOH Central Pharmacy	ANDA	Current
55154-7275	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Cardinal Health	ANDA	Current
55154-7275	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Cardinal Health	ANDA	Current
55154-7275	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Cardinal Health 107, LLC	ANDA	Current
55154-7275	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Cardinal Health	ANDA	Current
55154-7275	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Cardinal Health	ANDA	Current
55154-7998	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Cardinal Health	ANDA	Current
55154-7998	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Cardinal Health	ANDA	Current
55154-7998	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Cardinal Health 107, LLC	ANDA	Current
55154-7998	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Cardinal Health	ANDA	Current
55154-7998	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Cardinal Health	ANDA	Current
60429-367	Pravastatin Sodium	pravastatin sodium	Golden State Medical Supply	ANDA	Current
60429-367	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Golden State Medical Supply	ANDA	Current
60429-368	Pravastatin Sodium	pravastatin sodium	Golden State Medical Supply	ANDA	Current
60429-368	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Golden State Medical Supply	ANDA	Current
60429-369	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Golden State Medical Supply	ANDA	Current
60429-369	Pravastatin Sodium	pravastatin sodium	Golden State Medical Supply	ANDA	Current
60505-0168	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Apotex Corp.	ANDA	Current
60505-0168	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Apotex Corp.	ANDA	Current
60505-0168	PRAVASTATIN SODIUM	PRAVASTATIN SODIUM	Apotex Corp.	ANDA	Current