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

Start Over Subjects Drugs, Generic ✖

11. Formal meetings between FDA and ANDA applicants of complex products under GDUFA: guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, October 2022
Subject(s):: Drug Approval
Drugs, Generic
Government Regulation
Group Processes
United States
United States. Food and Drug Administration

12. ANDA submissions: amendments and requests for final approval to tentatively approved ANDAs

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, September 2020
Subject(s):: Drug Approval
Drug Industry
Drugs, Generic
Therapeutic Equivalency
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

13. Referencing approved drug products in ANDA submissions

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, October 2020
Subject(s):: Drug Approval
Drugs, Generic
Reference Books, Medical
Therapeutic Equivalency
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

14. Controlled correspondence related to generic drug development

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, December 2020
Subject(s):: Correspondence as Topic
Drug Development
Drugs, Generic
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

15. Referencing approved drug products in ANDA submissions

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, October 2020
Subject(s):: Drug Approval
Drug Evaluation
Drug Labeling
Drugs, Generic
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

16. ANDAs for certain highly purified synthetic peptide drug products that refer to listed drugs of rDNA origin

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, May 2021
Subject(s):: Chemistry Techniques, Synthetic
DNA, Ribosomal
Drug Approval
Drugs, Generic
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

17. Competitive generic therapies

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, March 2020
Subject(s):: Drug Approval
Drugs, Generic
Investigational New Drug Application
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

18. Cover letter attachments for controlled correspondence and ANDA submissions: guidance for industry

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, June 2023
Subject(s):: Correspondence as Topic
Drug Approval
Drug Industry
Drugs, Generic
Government Regulation
United States
United States. Food and Drug Administration

19. Generic medications: what you get is premium quality at a preferred price

Publication:: Morris Plains, N.J. : Warner Chilcott Laboratories ; [New York, N.Y. : HealthTeam Interactive Communications], c1990
Subject(s):: Drugs, Generic
Therapeutic Equivalency