Application 079169

Type: ANDA
Sponsor: SUN PHARM

Application Products#

Product, Drug, Ingredient table
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 table
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, Submission type, Date table
Document	Submission type	Date
9231	ORIG	2016-07-20

Application 079169

Related Records#

Application Products#

NDC Listings For This Application#

Documents#