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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 |