Application 076187

Type: ANDA
Sponsor: MYLAN

Related Records

Company: MYLAN

Application Products

Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	No	No
002	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	No	No
003	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	No	No
004	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	No	No
005	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	No	No
006	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	No	No
007	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	No	No
008	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	No	No
009	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	No	No
010	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	No	No
011	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	No	Yes
012	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	TABLET;ORAL	0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	No	No

NDC Listings For This Application

NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-1800	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1800	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1800	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1800	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1800	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1800	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1800	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1800	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1803	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1803	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1803	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1803	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1803	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1803	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1803	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1803	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1805	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1805	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1805	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1805	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1805	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1805	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1805	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1805	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1807	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1807	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1807	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1807	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1807	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1807	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1807	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1807	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1809	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1809	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1809	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1809	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1809	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1809	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1809	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1809	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1811	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1811	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1811	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1811	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1811	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1811	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1811	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1811	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1813	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1813	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1813	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1813	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1813	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1813	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1813	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1813	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1815	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1815	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1815	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1815	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1815	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1815	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1815	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1815	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1817	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1817	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1817	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1817	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1817	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1817	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1817	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1817	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1819	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1819	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1819	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1819	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1819	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1819	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1819	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1819	Levothyroxine Sodium	levothyroxine sodium	Mylan Pharmaceuticals Inc.	ANDA	Current

Documents

Document	Submission type	Date
43061	ORIG	2005-05-10
22544	SUPPL	2005-05-10
39509	ORIG	2004-02-18
22543	ORIG	2004-02-18
8875	ORIG	2004-02-18