Quote from Chief Pharmacist on November 20, 2024, 12:16 am

Please find the below FDA guidelines regarding ANDA:

1. ANDA Submissions — Amendments to Abbreviated New Drug Applications Under GDUFA
2. Facility Readiness: Goal Date Decisions Under GDUFA
3. ANDA Submissions – Prior Approval Supplements Under GDUFA
4. Good ANDA Submission Practices
5. Referencing Approved Drug Products in ANDA Submissions
6. ANDA Submissions —Content and Format
7. Determining Whether to Submit an ANDA or a 505(b)(2) Application
8. ANDA Submissions – Refuse-to-Receive Standards
9. Self-Identification of Generic Drug Facilities, Sites, and Organizations
10. Statistical Approaches to Establishing Bioequivalence
11. Submission of Summary Bioequivalence Data for ANDAs
12. ANDAs: Pharmaceutical Solid Polymorphism
13. 180-Day Generic Drug Exclusivity
14. 180-Day Exclusivity When Multiple ANDAs Are Submitted on the Same Day
15. Self-Identification of Generic Drug Facilities, Sites, and Organizations