Application 079169

Type: ANDA
Sponsor: SUN PHARM

Related Records

Company: SUN PHARM

Application Products

Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	TABLET;ORAL	5MG	No	No
002	ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	TABLET;ORAL	10MG	No	No
003	ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	TABLET;ORAL	20MG	No	No
004	ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	TABLET;ORAL	40MG	No	No

NDC Listings For This Application

NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
47335-582	Rosuvastatin Calcium	Rosuvastatin Calcium	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-582	Rosuvastatin Calcium	Rosuvastatin Calcium	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-582	Rosuvastatin Calcium	Rosuvastatin Calcium	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-582	Rosuvastatin Calcium	Rosuvastatin Calcium	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-582	Rosuvastatin Calcium	Rosuvastatin Calcium	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-583	Rosuvastatin Calcium	Rosuvastatin Calcium	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-583	Rosuvastatin Calcium	Rosuvastatin Calcium	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-583	Rosuvastatin Calcium	Rosuvastatin Calcium	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-583	Rosuvastatin Calcium	Rosuvastatin Calcium	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-583	Rosuvastatin Calcium	Rosuvastatin Calcium	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-584	Rosuvastatin Calcium	Rosuvastatin Calcium	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-584	Rosuvastatin Calcium	Rosuvastatin Calcium	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-584	Rosuvastatin Calcium	Rosuvastatin Calcium	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-584	Rosuvastatin Calcium	Rosuvastatin Calcium	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-584	Rosuvastatin Calcium	Rosuvastatin Calcium	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-585	Rosuvastatin Calcium	Rosuvastatin Calcium	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-585	Rosuvastatin Calcium	Rosuvastatin Calcium	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-585	Rosuvastatin Calcium	Rosuvastatin Calcium	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-585	Rosuvastatin Calcium	Rosuvastatin Calcium	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-585	Rosuvastatin Calcium	Rosuvastatin Calcium	Sun Pharmaceutical Industries, Inc.	ANDA	Current

Documents

Document	Title	Submission type	Submission no.	Date	Storage
9231	0	ORIG	1	2016-07-20	Cached in FDA.report object storage