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Generated: May 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090326

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NDA 090326 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 090326
Tradename:LIOTHYRONINE SODIUM
Applicant:Mylan
Ingredient:liothyronine sodium
Patents:0
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Thyroid)
Formulation / Manufacturing:see details
Pharmacology for NDA: 090326
Ingredient-typeTriiodothyronine
Suppliers and Packaging for NDA: 090326
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LIOTHYRONINE SODIUM liothyronine sodium TABLET;ORAL 090326 ANDA Mylan Pharmaceuticals Inc. 0378-3611 N 0378-3611-01
LIOTHYRONINE SODIUM liothyronine sodium TABLET;ORAL 090326 ANDA Mylan Pharmaceuticals Inc. 0378-3612 N 0378-3612-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 0.005MG BASE
Approval Date:Jul 14, 2009TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 0.025MG BASE
Approval Date:Jul 14, 2009TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 0.05MG BASE
Approval Date:Jul 14, 2009TE:ABRLD:No

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