Application 200465

Type: ANDA
Sponsor: MYLAN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM	TABLET;ORAL	EQ 2.5MG BASE;EQ 10MG BASE	No	No
002	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM	TABLET;ORAL	EQ 2.5MG BASE;EQ 20MG BASE	No	No
003	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM	TABLET;ORAL	EQ 2.5MG BASE;EQ 40MG BASE	No	No
004	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM	TABLET;ORAL	EQ 5MG BASE;EQ 10MG BASE	No	No
005	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM	TABLET;ORAL	EQ 5MG BASE;EQ 20MG BASE	No	No
006	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM	TABLET;ORAL	EQ 5MG BASE;EQ 40MG BASE	No	No
007	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM	TABLET;ORAL	EQ 5MG BASE;EQ 80MG BASE	No	No
008	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM	TABLET;ORAL	EQ 10MG BASE;EQ 10MG BASE	No	No
009	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM	TABLET;ORAL	EQ 10MG BASE;EQ 20MG BASE	No	No
010	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM	TABLET;ORAL	EQ 10MG BASE;EQ 40MG BASE	No	No
011	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM	TABLET;ORAL	EQ 10MG BASE;EQ 80MG BASE	No	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-4510	Amlodipine and atorvastatin	Amlodipine and atorvastatin	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4510	Amlodipine and atorvastatin	Amlodipine and atorvastatin	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4511	Amlodipine and atorvastatin	Amlodipine and atorvastatin	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4511	Amlodipine and atorvastatin	Amlodipine and atorvastatin	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4512	Amlodipine and atorvastatin	Amlodipine and atorvastatin	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4512	Amlodipine and atorvastatin	Amlodipine and atorvastatin	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4513	Amlodipine and atorvastatin	Amlodipine and atorvastatin	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4513	Amlodipine and atorvastatin	Amlodipine and atorvastatin	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4513	Amlodipine and atorvastatin	Amlodipine and atorvastatin	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4513	Amlodipine and atorvastatin	Amlodipine and atorvastatin	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4513	Amlodipine and atorvastatin	Amlodipine and atorvastatin	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4514	Amlodipine and atorvastatin	Amlodipine and atorvastatin	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4514	Amlodipine and atorvastatin	Amlodipine and atorvastatin	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4514	Amlodipine and atorvastatin	Amlodipine and atorvastatin	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4514	Amlodipine and atorvastatin	Amlodipine and atorvastatin	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4514	Amlodipine and atorvastatin	Amlodipine and atorvastatin	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4515	Amlodipine and atorvastatin	Amlodipine and atorvastatin	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4515	Amlodipine and atorvastatin	Amlodipine and atorvastatin	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4515	Amlodipine and atorvastatin	Amlodipine and atorvastatin	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4515	Amlodipine and atorvastatin	Amlodipine and atorvastatin	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4515	Amlodipine and atorvastatin	Amlodipine and atorvastatin	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4516	Amlodipine and atorvastatin	Amlodipine and atorvastatin	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4516	Amlodipine and atorvastatin	Amlodipine and atorvastatin	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4516	Amlodipine and atorvastatin	Amlodipine and atorvastatin	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4516	Amlodipine and atorvastatin	Amlodipine and atorvastatin	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4516	Amlodipine and atorvastatin	Amlodipine and atorvastatin	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4517	Amlodipine and atorvastatin	Amlodipine and atorvastatin	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4517	Amlodipine and atorvastatin	Amlodipine and atorvastatin	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4517	Amlodipine and atorvastatin	Amlodipine and atorvastatin	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4517	Amlodipine and atorvastatin	Amlodipine and atorvastatin	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4517	Amlodipine and atorvastatin	Amlodipine and atorvastatin	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4518	Amlodipine and atorvastatin	Amlodipine and atorvastatin	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4518	Amlodipine and atorvastatin	Amlodipine and atorvastatin	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4518	Amlodipine and atorvastatin	Amlodipine and atorvastatin	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4518	Amlodipine and atorvastatin	Amlodipine and atorvastatin	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4518	Amlodipine and atorvastatin	Amlodipine and atorvastatin	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4519	Amlodipine and atorvastatin	Amlodipine and atorvastatin	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4519	Amlodipine and atorvastatin	Amlodipine and atorvastatin	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4519	Amlodipine and atorvastatin	Amlodipine and atorvastatin	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4519	Amlodipine and atorvastatin	Amlodipine and atorvastatin	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4519	Amlodipine and atorvastatin	Amlodipine and atorvastatin	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4520	Amlodipine and atorvastatin	Amlodipine and atorvastatin	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4520	Amlodipine and atorvastatin	Amlodipine and atorvastatin	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4520	Amlodipine and atorvastatin	Amlodipine and atorvastatin	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4520	Amlodipine and atorvastatin	Amlodipine and atorvastatin	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-4520	Amlodipine and atorvastatin	Amlodipine and atorvastatin	Mylan Pharmaceuticals Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
32023	ORIG	2013-12-05

Application 200465

Related Records#

Application Products#

NDC Listings For This Application#

Documents#