Application 021210

Type: NDA
Sponsor: STEVENS J

Related Records

Company: STEVENS J

Application Products

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

NDC Listings For This Application

NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0527-1341	Levothyroxine Sodium	Levothyroxine Sodium	Lannett Company, Inc.	NDA	Current
0527-1342	Levothyroxine Sodium	Levothyroxine Sodium	Lannett Company, Inc.	NDA	Current
0527-1343	Levothyroxine Sodium	Levothyroxine Sodium	Lannett Company, Inc.	NDA	Current
0527-1344	Levothyroxine Sodium	Levothyroxine Sodium	Lannett Company, Inc.	NDA	Current
0527-1345	Levothyroxine Sodium	Levothyroxine Sodium	Lannett Company, Inc.	NDA	Current
0527-1346	Levothyroxine Sodium	Levothyroxine Sodium	Lannett Company, Inc.	NDA	Current
0527-1347	Levothyroxine Sodium	Levothyroxine Sodium	Lannett Company, Inc.	NDA	Current
0527-1349	Levothyroxine Sodium	Levothyroxine Sodium	Lannett Company, Inc.	NDA	Current
0527-1350	Levothyroxine Sodium	Levothyroxine Sodium	Lannett Company, Inc.	NDA	Current
0527-1351	Levothyroxine Sodium	Levothyroxine Sodium	Lannett Company, Inc.	NDA	Current
0527-1352	Levothyroxine Sodium	Levothyroxine Sodium	Lannett Company, Inc.	NDA	Current
0527-1370	UNITHROID	levothyroxine sodium	Lannett Company, Inc.	NDA	Current
0527-1371	UNITHROID	levothyroxine sodium	Lannett Company, Inc.	NDA	Current
0527-1372	UNITHROID	levothyroxine sodium	Lannett Company, Inc.	NDA	Current
0527-1373	UNITHROID	levothyroxine sodium	Lannett Company, Inc.	NDA	Current
0527-1374	UNITHROID	levothyroxine sodium	Lannett Company, Inc.	NDA	Current
0527-1375	UNITHROID	levothyroxine sodium	Lannett Company, Inc.	NDA	Current
0527-1376	UNITHROID	levothyroxine sodium	Lannett Company, Inc.	NDA	Current
0527-1377	UNITHROID	levothyroxine sodium	Lannett Company, Inc.	NDA	Current
0527-1378	UNITHROID	levothyroxine sodium	Lannett Company, Inc.	NDA	Current
0527-1379	UNITHROID	levothyroxine sodium	Lannett Company, Inc.	NDA	Current
0527-1380	UNITHROID	levothyroxine sodium	Lannett Company, Inc.	NDA	Current
0527-1638	Levothyroxine Sodium	Levothyroxine Sodium	Lannett Company, Inc.	NDA	Current
0527-1639	UNITHROID	levothyroxine sodium	Lannett Company, Inc.	NDA	Current
10544-228	Levothyroxine Sodium	Levothyroxine Sodium	Blenheim Pharmacal, Inc.	NDA	Current
10544-229	Levothyroxine Sodium	Levothyroxine Sodium	Blenheim Pharmacal, Inc.	NDA	Current
10544-247	Levothyroxine Sodium	Levothyroxine Sodium	Blenheim Pharmacal, Inc.	NDA	Current
10544-256	Levothyroxine Sodium	Levothyroxine Sodium	Blenheim Pharmacal, Inc.	NDA	Current
10544-257	Levothyroxine Sodium	Levothyroxine Sodium	Blenheim Pharmacal, Inc.	NDA	Current
10544-258	Levothyroxine Sodium	Levothyroxine Sodium	Blenheim Pharmacal, Inc.	NDA	Current
10544-260	Levothyroxine Sodium	Levothyroxine Sodium	Blenheim Pharmacal, Inc.	NDA	Current
10544-261	Levothyroxine Sodium	Levothyroxine Sodium	Blenheim Pharmacal, Inc.	NDA	Current
10544-262	Levothyroxine Sodium	Levothyroxine Sodium	Blenheim Pharmacal, Inc.	NDA	Current
10544-264	Levothyroxine Sodium	Levothyroxine Sodium	Blenheim Pharmacal, Inc.	NDA	Current
10544-266	Levothyroxine Sodium	Levothyroxine Sodium	Blenheim Pharmacal, Inc.	NDA	Current
10544-267	Levothyroxine Sodium	Levothyroxine Sodium	Blenheim Pharmacal, Inc.	NDA	Current
21695-748	Levothyroxine Sodium	Levothyroxine Sodium	Rebel Distributors Corp.	NDA	Current
21695-749	Levothyroxine Sodium	Levothyroxine Sodium	Rebel Distributors Corp.	NDA	Current
21695-750	Levothyroxine Sodium	Levothyroxine Sodium	Rebel Distributors Corp.	NDA	Current
21695-751	Levothyroxine Sodium	Levothyroxine Sodium	Rebel Distributors Corp	NDA	Current
21695-752	Levothyroxine Sodium	Levothyroxine Sodium	Rebel Distributors Corp.	NDA	Current
21695-753	Levothyroxine Sodium	Levothyroxine Sodium	Rebel Distributors Corp	NDA	Current
21695-754	Levothyroxine Sodium	Levothyroxine Sodium	Rebel Distributors Corp.	NDA	Current
21695-755	Levothyroxine Sodium	Levothyroxine Sodium	Rebel Distributors Corp	NDA	Current
21695-756	Levothyroxine Sodium	Levothyroxine Sodium	Rebel Distributors Corp.	NDA	Current
21695-757	Levothyroxine Sodium	Levothyroxine Sodium	Rebel Distributors Corp	NDA	Current
21695-758	Levothyroxine Sodium	Levothyroxine Sodium	Rebel Distributors Corp.	NDA	Current
35356-515	Levothyroxine Sodium	Levothyroxine Sodium	Lake Erie Medical DBA Quality Care Products LLC	NDA	Current
35356-772	Levothyroxine Sodium	Levothyroxine Sodium	Lake Erie Medical DBA Quality Care Products LLC	NDA	Current
43063-191	Levothyroxine Sodium	Levothyroxine Sodium	PD-Rx Pharmaceuticals, Inc.	NDA	Current
43063-420	Levothyroxine Sodium	Levothyroxine Sodium	PD-Rx Pharmaceuticals, Inc.	NDA	Current
43063-421	Levothyroxine Sodium	Levothyroxine Sodium	PD-Rx Pharmaceuticals, Inc.	NDA	Current
43063-422	Levothyroxine Sodium	Levothyroxine Sodium	PD-Rx Pharmaceuticals, Inc.	NDA	Current
43063-475	Levothyroxine Sodium	Levothyroxine Sodium	PD-Rx Pharmaceuticals, Inc.	NDA	Current
43063-945	Levothyroxine Sodium	Levothyroxine Sodium	PD-Rx Pharmaceuticals, Inc.	NDA	Current
43063-945	Levothyroxine Sodium	Levothyroxine Sodium	PD-Rx Pharmaceuticals, Inc.	NDA	Current
43063-945	Levothyroxine Sodium	Levothyroxine Sodium	PD-Rx Pharmaceuticals, Inc.	NDA	Current
43063-945	Levothyroxine Sodium	Levothyroxine Sodium	PD-Rx Pharmaceuticals, Inc.	NDA	Current
43063-945	Levothyroxine Sodium	Levothyroxine Sodium	PD-Rx Pharmaceuticals, Inc.	NDA	Current
43063-948	Levothyroxine Sodium	Levothyroxine Sodium	PD-Rx Pharmaceuticals, Inc.	NDA	Current
43063-948	Levothyroxine Sodium	Levothyroxine Sodium	PD-Rx Pharmaceuticals, Inc.	NDA	Current
43063-948	Levothyroxine Sodium	Levothyroxine Sodium	PD-Rx Pharmaceuticals, Inc.	NDA	Current
43063-948	Levothyroxine Sodium	Levothyroxine Sodium	PD-Rx Pharmaceuticals, Inc.	NDA	Current
43063-948	Levothyroxine Sodium	Levothyroxine Sodium	PD-Rx Pharmaceuticals, Inc.	NDA	Current
43063-949	Levothyroxine Sodium	Levothyroxine Sodium	PD-Rx Pharmaceuticals, Inc.	NDA	Current
43063-949	Levothyroxine Sodium	Levothyroxine Sodium	PD-Rx Pharmaceuticals, Inc.	NDA	Current
43063-949	Levothyroxine Sodium	Levothyroxine Sodium	PD-Rx Pharmaceuticals, Inc.	NDA	Current
43063-949	Levothyroxine Sodium	Levothyroxine Sodium	PD-Rx Pharmaceuticals, Inc.	NDA	Current
43063-949	Levothyroxine Sodium	Levothyroxine Sodium	PD-Rx Pharmaceuticals, Inc.	NDA	Current
43063-949	Levothyroxine Sodium	Levothyroxine Sodium	PD-Rx Pharmaceuticals, In	NDA	Current
43063-950	Levothyroxine Sodium	Levothyroxine Sodium	PD-Rx Pharmaceuticals, Inc.	NDA	Current
43063-950	Levothyroxine Sodium	Levothyroxine Sodium	PD-Rx Pharmaceuticals, Inc.	NDA	Current
43063-950	Levothyroxine Sodium	Levothyroxine Sodium	PD-Rx Pharmaceuticals, Inc.	NDA	Current
43063-950	Levothyroxine Sodium	Levothyroxine Sodium	PD-Rx Pharmaceuticals, Inc.	NDA	Current
43063-950	Levothyroxine Sodium	Levothyroxine Sodium	PD-Rx Pharmaceuticals, Inc.	NDA	Current
43063-950	Levothyroxine Sodium	Levothyroxine Sodium	PD-Rx Pharmaceuticals, Inc.	NDA	Current
43063-951	Levothyroxine Sodium	Levothyroxine Sodium	PD-Rx Pharmaceuticals, Inc.	NDA	Current
43063-951	Levothyroxine Sodium	Levothyroxine Sodium	PD-Rx Pharmaceuticals, Inc.	NDA	Current
43063-951	Levothyroxine Sodium	Levothyroxine Sodium	PD-Rx Pharmaceuticals, Inc.	NDA	Current
43063-951	Levothyroxine Sodium	Levothyroxine Sodium	PD-Rx Pharmaceuticals, Inc.	NDA	Current

Documents

Document	Submission type	Date
56834	SUPPL	2018-12-20
56720	SUPPL	2018-12-12
21510	SUPPL	2011-02-15
44106	ORIG	2009-05-30
36360	SUPPL	2008-02-14
27077	SUPPL	2008-02-14
21509	SUPPL	2005-05-13
21508	SUPPL	2005-05-13
4644	SUPPL	2004-12-22
27076	SUPPL	2004-06-24
42031	ORIG	2000-08-21
27075	ORIG	2000-08-21
14639	ORIG	2000-08-21