Regulations.gov document
Exhibit 3 re Request the Commissioner of FDA to require any ANDA applicant who cites…
Supporting & Related Material · FDA-2016-P-2782 · posted Sep 19, 2016
Key facts
| Document ID | FDA-2016-P-2782-0005 |
|---|---|
| Title | Exhibit 3 re Request the Commissioner of FDA to require any ANDA applicant who cites Ciprodex as the RLD to establish bioequivalence by performing in vivo clinical endpoint studies |
| Document type | Supporting & Related Material |
| Subtype | Background Material |
| Agency | FDA |
| Docket | FDA-2016-P-2782 |
| Posted | Sep 19, 2016 |
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