FDA ANDA 013601, MUCOMYST, APOTHECON, 09/14/1963

Content: Summary Basis of Approval for original NDA in Sept. 1963 and Efficacy Supplements 035 (01/31/1985) and 046 (03/13/2009).

ANDA: 013601
Company: APOTHECON
Drug Name: MUCOMYST
Active Ingredients: ACETYLCYSTEINE
Strength: 10% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage Form/Route: SOLUTION;INHALATION, ORAL
Action Date: 09/14/1963
Marketing Status: Discontinued
Submission Classification: ORIG-1

214 Pages