Subjects: Drugs, Generic -- standards - Digital Collections - National Library of Medicine Search Results

Start Over Subjects Drugs, Generic -- standards ✖

1. ANDA submissions--amendments to abbreviated new drug applications under GDUFA

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, July 2018
Subject(s):: Drugs, Generic -- standards
Investigational New Drug Application
Drug Approval
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

2. Size, shape, and other physical attributes of generic tablets and capsules: guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, October 2022
Subject(s):: Capsules -- standards
Drugs, Generic -- standards
Government Regulation
Tablets -- standards
United States
United States. Food and Drug Administration