Complete Response Letters
Baxter Healthcare Corporation: DAPZURA RT
What FDA's Complete Response Letters to the company say, in the letters' own words.
Complete Response Letter, Mar 29, 2024
No complete sentence from this letter is available from the knowledge graph yet.
Complete Response Letter, Mar 27, 2024
No complete sentence from this letter is available from the knowledge graph yet.
Complete Response Letter, Apr 29, 2021
Food, Drug, and Cosmetic Act for DAPZURA RT (daptomycin) for Injection.
CRL_NDA213645_20210429:p1:s12In your submission dated March 31, 2021, in response to an information request, you have not provided adequate safety information to support the qualification of the following leachables:
CRL_NDA213645_20210429:p1:s18By providing a draft protocol for comment, the Agency will be better able to work with you on designing a study that can best inform the safety of the identified leachables when administered at clinically relevant exposures.
CRL_NDA213645_20210429:p1:s36More Complete Response Letters
Updated Sep 30, 2026 · built from 283 companies in the EphemerisX knowledge graph. This page is regenerated as companies are added.