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Generated: January 16, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076923

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NDA 076923 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 076923
Applicant:X Gen Pharms
Ingredient:liothyronine sodium
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Thyroid)
Formulation / Manufacturing:see details
Pharmacology for NDA: 076923
Suppliers and Packaging for NDA: 076923
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LIOTHYRONINE SODIUM liothyronine sodium INJECTABLE;INJECTION 076923 ANDA X-GEN Pharmaceuticals, Inc. 39822-0151 39822-0151-1 1 VIAL in 1 CARTON (39822-0151-1) > 1 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 0.01MG BASE/ML
Approval Date:Aug 17, 2005TE:APRLD:No

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Serving leading biopharmaceutical companies globally:

Express Scripts
Queensland Health
Harvard Business School

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