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Generated: May 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090097

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NDA 090097 describes LIOTHYRONINE SODIUM, which is a drug marketed by X Gen Pharms, Mayne Pharma Inc, Mylan, Sigmapharm Labs Llc, Sun Pharm Inds Ltd, and Watson Labs, and is included in seven NDAs. It is available from seventeen suppliers. Additional details are available on the LIOTHYRONINE SODIUM profile page.

The generic ingredient in LIOTHYRONINE SODIUM is liothyronine sodium. There are four drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the liothyronine sodium profile page.
Summary for 090097
Tradename:LIOTHYRONINE SODIUM
Applicant:Mayne Pharma Inc
Ingredient:liothyronine sodium
Patents:0
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Thyroid)
Formulation / Manufacturing:see details
Pharmacology for NDA: 090097
Ingredient-typeTriiodothyronine
Suppliers and Packaging for NDA: 090097
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LIOTHYRONINE SODIUM liothyronine sodium TABLET;ORAL 090097 ANDA KAISER FOUNDATION HOSPITALS 0179-0018 N 0179-0018-70
LIOTHYRONINE SODIUM liothyronine sodium TABLET;ORAL 090097 ANDA KAISER FOUNDATION HOSPITALS 0179-0019 N 0179-0019-70

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 0.005MG BASE
Approval Date:Mar 20, 2009TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 0.025MG BASE
Approval Date:Mar 20, 2009TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 0.05MG BASE
Approval Date:Mar 20, 2009TE:ABRLD:No

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