Details for New Drug Application (NDA): 206163

NDA 206163 describes LEVOTHYROXINE SODIUM, which is a drug marketed by Ani Pharms, Dr Reddys, Fresenius Kabi Usa, Maia Pharms Inc, Onesource Specialty, Ph Health, Piramal Critical, Xiromed, Zydus Pharms, Hikma, Accord Hlthcare, Amneal, Ascent Pharms Inc, Aurobindo Pharma, Lupin, Macleods Pharms Ltd, Merck Kgaa, Mylan, and Watson Labs Teva, and is included in twenty-one NDAs. It is available from thirty-eight suppliers. There are seven patents protecting this drug and two Paragraph IV challenges. Additional details are available on the LEVOTHYROXINE SODIUM profile page.

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

Summary for 206163

Tradename:	LEVOTHYROXINE SODIUM
Applicant:	Piramal Critical
Ingredient:	levothyroxine sodium
Patents:	0

Pharmacology for NDA: 206163

Suppliers and Packaging for NDA: 206163

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LEVOTHYROXINE SODIUM	levothyroxine sodium	POWDER;INTRAVENOUS	206163	ANDA	Piramal Critical Care, Inc.	66794-200	66794-200-02	5 mL in 1 VIAL, SINGLE-USE (66794-200-02)
LEVOTHYROXINE SODIUM	levothyroxine sodium	POWDER;INTRAVENOUS	206163	ANDA	Piramal Critical Care, Inc.	66794-201	66794-201-02	5 mL in 1 VIAL, SINGLE-USE (66794-201-02)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER;INTRAVENOUS			Strength	100MCG/VIAL
Approval Date:	Jun 29, 2016	TE:	AP	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER;INTRAVENOUS			Strength	500MCG/VIAL
Approval Date:	Jun 29, 2016	TE:	AP	RLD:	No

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