Complete Response Letters
Spectrum Pharmaceuticals, Inc.: SPI-2012
What FDA's Complete Response Letters to the company say, in the letters' own words.
Complete Response Letter, Aug 3, 2021
Satisfactory resolution of these deficiencies is required before this application may be approved.
CRL_BLA761148_20210803:p1:s18July 22, 2020. We reserve comment on the proposed container label and carton labeling until the application is otherwise adequate.
CRL_BLA761148_20210803:p1:s38More Complete Response Letters
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