Below is a sortable listing of Generics Guidances. To view the most recently posted Generics Guidances, please click on Date in the header block of the chart.

Generics 180-Day Exclusivity When Multiple ANDAs Are Submitted on the Same Day (PDF - 138KB) Final Guidance 07/01/03
Generics/User Fees Controlled Correspondence Related to Generic Drug Development (PDF - 379KB) Final Guidance 09/28/15
Generics Court Decisions, ANDA Approvals, and 180-Day Exclusivity Under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act. (PDF - 25KB) Final Guidance 03/01/00
Generics Handling and Retention of Bioavailability BA and Bioequivalence BE Testing Samples (PDF - 190KB) Final Guidance 05/25/04
Generics Individual Product Bioequivalence Recommendations for Specific Products (PDF - 80KB) Final Guidance 06/10/10
Generics Letter describing efforts by the CDER and the ORA to clarify the responsibilities of CDER chemistry review scientists and ORA field investigators in the new and abbreviated drug approval process in order to reduce duplication or redundancy in the process (PDF - 274KB) Final Guidance 10/01/94
Generics Letter on incomplete Abbreviated Applications, Convictions Under GDEA, Multiple Supplements, Annual Reports for Bulk Antibiotics, Batch Size for Transdermal Drugs, Bioequivalence Protocols, Research, Deviations from OGD Policy (PDF - 1.9MB) Final Guidance 09/01/94
Generics Letter on the Provision of new information pertaining to new bioequivalence guidelines and refuse-to-file letters (PDF - 254KB) Final Guidance 07/01/92
Generics Letter on the provision of new procedures and policies affecting the generic drug review process (PDF - 608KB) Final Guidance 03/01/89
Generics Letter on the request for cooperation of regulated industry to improve the efficiency and effectiveness of the generic drug review process, by assuring the completeness and accuracy of required information and data submissions (PDF - 917KB) Final Guidance 11/01/90
Generics Letter on the response to 12/20/1984 letter from the Pharmaceutical Manufacturers Association about the Drug Price Competition and Patent Term Restoration Act (PDF - 392KB) Final Guidance 03/01/85
Generics Letter to all ANDA and AADA applicants about the Generic Drug Enforcement Act of 1992 (GDEA), and the Office of Generic Drugs intention to refuse-to-file incomplete submissions as required by the new law (PDF - 233KB) Final Guidance 01/01/93
Generics Letter to regulated industry notifying interested parties about important detailed information regarding labeling, scale-up, packaging, minor/major amendment criteria and bioequivalence requirements (PDF - 908KB) Final Guidance 08/01/93
Generics Revising ANDA Labeling Following Revision of the RLD Labeling (PDF - 19KB) Final Guidance 04/26/00
Generics Submission of Summary Bioequivalence Data for Abbreviated New Drug Applications (PDF - 137KB) Final Guidance 05/05/11
Generics Variations in Drug Products that May Be Included in a Single ANDA (PDF - 107KB) Final Guidance 12/01/98
User Fees /Generics Generic Drug User Fee Amendments of 2012: Questions and Answers Related to User Fee Assessments (PDF - 222KB) Final Guidance 11/21/16
Generics / User Fees ANDA Submissions -- Refuse-to-Receive Standards Rev.2 (PDF - 199KB) Final Guidance 12/21/16
Generics /User Fees ANDA Submissions — Content and Format of Abbreviated New Drug Applications (PDF - 308KB) Final Guidance 09/24/18
Generics/User Fees ANDA Submissions--Amendments to Abbreviated New Drug Applications Under GDUFA; Guidance for Industry  (PDF - 219KB) Final Guidance 07/03/18
Generics / User Fees ANDA Submissions – Prior Approval Supplements Under GDUFA (PDF - 147KB) Final Guidance 10/04/17
Generics /User Fees ANDA Submissions — Refuse to Receive for Lack of Justification of Impurity Limits (PDF - 326KB) Final Guidance 08/24/16
Generics /User Fees How to Obtain a Letter from FDA Stating that Bioequivalence Study Protocols Contain Safety Protections Comparable to Applicable REMS for RLD (PDF - 72KB) Draft Guidance 12/04/14
Generics Acceptability of Draft Labeling to Support Abbreviated New Drug Application Approval; Guidance for Industry (PDF - 53KB) Draft Guidance 10/05/15
Generics/User Fees/ Pharmaceutical Quality/CMC Completeness Assessments for Type II API DMFs Under GDUFA Guidance for Industry (PDF - 379KB) Final Guidance 10/04/17
Generics General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products Guidance for Industry (PDF - 520KB) Final Guidance 11/21/17
Generics Assessing Adhesion with Transdermal Delivery Systems and Topical Patches for ANDAs Draft Guidance for Industry (PDF - 187KB) Revised Draft Guidance 10/09/18
Generics Updating ANDA Labeling After the Marketing Application for the Reference Listed Drug Has Been Withdrawn Guidance for Industry (PDF - 94KB) Draft Guidance 07/08/16
Generics / User Fees Self-Identification of Generic Drug Facilities, Sites, and Organizations; Guidance for Industry (PDF - 268KB) Final Guidance 09/22/16
User Fees / Generics Generic Drug User Fee Amendments of 2012: Questions and Answers Related to Self-Identification of Facilities, Review of Generic Drug Submissions, and Inspections and Compliance Guidance for Industry (PDF - 131KB) Final Guidance 07/25/17
Generics Guidance for Industry 180-Day Exclusivity: Questions and Answers (PDF - 240KB) Draft 01/12/17
Generics Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA: Draft Guidance for Industry (PDF - 200KB) Draft Guidance 01/13/17
Generics Referencing Approved Drug Products in ANDA Submissions Guidance for Industry (PDF - 155KB) Draft Guidance 01/13/17
Generics - User Fees ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin Guidance for Industry (PDF - 105KB) Draft Guidance 10/02/17
Generics - User Fees Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA Guidance for Industry (PDF - 154KB) Draft Guidance 10/02/17
Generics - User Fees ANDA Submissions - Refuse-to-Receive Standards: : Questions and Answers Guidance for Industry (PDF - 153KB) Draft Guidance 10/02/17
Generics - User Fees Requests for Reconsideration at the Division Level Under GDUFA Guidance for Industry (PDF - 99KB) Draft Guidance 10/11/17
Generics Determining Whether to Submit an ANDA or a 505(b)(2) Application Guidance for Industry (PDF - 147KB) Draft Guidance 10/11/17
Generics / User Fees Post-Complete Response Letter Meetings Between FDA and ANDA Applicants Under GDUFA (PDF - 101KB) Final Guidance 12/03/18
Generics - User Fees Controlled Correspondence Related to Generic Drug Development Draft Guidance for Industry (PDF - 171KB) Draft Guidance 11/02/17
Generics / User fees Information Requests and Discipline Review Letters Under the Generic Drug User Fee Amendments; Draft Guidance for Industry (PDF - 81KB) Draft Guidance 12/15/17
Pharmaceutical Quality/CMC / Generics ANDAs: Pre-Submission of Facility Information Related to Prioritized Generic Drug Applications (Pre-Submission Facility Correspondence) Guidance for Industry (PDF - 151KB) Draft Guidance 11/03/17
Generics Good ANDA Submission Practices Guidance for Industry (PDF - 250KB) Draft Guidance 01/03/18
Generics Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs Guidance for Industry (PDF - 235KB) Draft Guidance 10/09/18
User Fees / Generics Assessing User Fees Under the Generic Drug User Fee Amendments of 2017 Guidance for Industry (PDF - 708KB) Draft Guidance 10/27/17
Generics ANDA Submissions – Amendments and Requests for Final Approval to Tentatively Approved ANDAs Guidance for Industry.  (PDF - 135KB) Draft Guidance 01/16/19
Generics Competitive Generic Therapies Guidance for Industry (PDF - 186KB) Draft Guidance 02/15/19

Page Last Updated: 02/14/2019
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