Stay in the Loop!

Sign-up for our newsletter to be notified of new content.

BioTechLogic Logo

« Back to: US Regulatory References

Submission Requirements

505(b)(1)505(b)(2)505(j) ANDA
Pre-Clinical Pre-Clinical  
Clinical Clinical  
Pediatric Use Pediatric Use  
Chemistry (CMC) Chemistry (CMC) Chemistry (CMC)
PK and Bioavailability PK and Comp Bioavailability Bioequivalence
Labeling Labeling Labeling
Patient Info Patient Info Patient Info
Exclusivity Request Patent Certification Patent Certification
Exclusivity Request Exclusivity Statements