is indicated for the initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation and hemodynamically unstable ventricular tachycardia in patients refractory to other therapy, and is the generic equivalent of Wyeth Pharmaceuticals' Cordarone I.
Clinical activities for the development of the injectable form of amiodarone hydrochloride
, which has been granted an orphan drug status by the Japanese Authorities, have already been transferred to Sanofi-Synthelabo K.
In April of 2001, Taro received approval from the FDA of its ANDA for Amiodarone Hydrochloride
Tablets, 200 mg, bioequivalent to Wyeth-Ayerst Laboratories' Cordarone(R).
has received approval of an Abbreviated New Drug Application (ANDA) from the Food and Drug Administration (FDA) for Amiodarone Hydrochloride
1 Million in Q1 2000 -- Approval of ANDA for Amiodarone Hydrochloride
Tablets and Enalapril Maleate Tablets in Two Strengths -- Tentative Approval of Enalapril Maleate/Hydrochlorothiazide Tablets in Two Strengths
The Company currently markets Warfarin Sodium Tablets and Acetazolamide Tablets, in addition to the more recent approvals for Amiodarone Hydrochloride
Tablets, Enalapril Maleate Tablets and Enalapril/HCTZ.
American Pharmaceutical Partners, APP, , today announced that it has received multiple contract awards for amiodarone hydrochloride
from group purchasing organizations (GPOs), including a private label award from Novation, Inc.
Food and Drug Administration (FDA) approving its Abbreviated New Drug Application (ANDA) for Amiodarone Hydrochloride
Other products approved this year include Amiodarone Hydrochloride
for Injection (the generic equivalent of Wyeth Pharmaceuticals' Cordarone IV), Levothyroxine Sodium for Injection (the generic equivalent of Abbott Laboratories' injectable Synthroid) and Calcitriol for Injection (the generic version of Abbott's Calcijex).