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Generated: May 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 200295

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NDA 200295 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 200295
Tradename:LIOTHYRONINE SODIUM
Applicant:Sigmapharm Labs Llc
Ingredient:liothyronine sodium
Patents:0
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Thyroid)
Formulation / Manufacturing:see details
Pharmacology for NDA: 200295
Ingredient-typeTriiodothyronine
Suppliers and Packaging for NDA: 200295
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LIOTHYRONINE SODIUM liothyronine sodium TABLET;ORAL 200295 ANDA SIGMAPHARM LABORATORIES, LLC 42794-018 N 42794-018-02
LIOTHYRONINE SODIUM liothyronine sodium TABLET;ORAL 200295 ANDA SIGMAPHARM LABORATORIES, LLC 42794-018 N 42794-018-06

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 0.005MG BASE
Approval Date:Nov 29, 2012TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 0.025MG BASE
Approval Date:Nov 29, 2012TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 0.05MG BASE
Approval Date:Nov 29, 2012TE:ABRLD:No

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Cipla
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