Details for New Drug Application (NDA): 021292

NDA 021292 describes EUTHYROX, which is a drug marketed by Emd Serono Inc and is included in one NDA. It is available from one supplier. Additional details are available on the EUTHYROX profile page.

The generic ingredient in EUTHYROX is levothyroxine sodium. There are ten drug master file entries for this compound. Fifty-three suppliers are listed for this compound. Additional details are available on the levothyroxine sodium profile page.

Summary for 021292

Tradename:	EUTHYROX
Applicant:	Emd Serono Inc
Ingredient:	levothyroxine sodium
Patents:	0

Pharmacology for NDA: 021292

Suppliers and Packaging for NDA: 021292

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
EUTHYROX	levothyroxine sodium	TABLET;ORAL	021292	NDA	Provell Pharmaceuticals, LLC	72305-025	72305-025-30	2 BLISTER PACK in 1 CARTON (72305-025-30) / 15 TABLET in 1 BLISTER PACK
EUTHYROX	levothyroxine sodium	TABLET;ORAL	021292	NDA	Provell Pharmaceuticals, LLC	72305-025	72305-025-90	6 BLISTER PACK in 1 CARTON (72305-025-90) / 15 TABLET in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date:	May 31, 2002	TE:	AB2	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date:	May 31, 2002	TE:	AB2	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date:	May 31, 2002	TE:	AB2	RLD:	No

Complete Access Available with Subscription