Complete Response Letters
Braintree Laboratories, Inc.: Suflave
What FDA's Complete Response Letters to the company say, in the letters' own words.
Complete Response Letter, Jun 6, 2022
Please refer to your new drug application (NDA) dated and received on August 6, 2021, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act for Suflave (polyethylene glycol 3350, sodium sulfate, potassium chloride, magnesium sulfate, and sodium chloride) for oral solution.
CRL_NDA215344_20220606:p1:s11Complete Response Letter, Mar 13, 2020
Food, Drug, and Cosmetic Act for SUTAB (sodium sulfate, magnesium sulfate, and potassium chloride) tablets.
CRL_NDA213135_20200313:p1:s12During a recent inspection of the Braintree Laboratories, Inc., MA (FEI1000513636) manufacturing facility for this application, our field investigator conveyed deficiencies to the representative of the facility.
CRL_NDA213135_20200313:p1:s16Submit draft carton and container labeling based on your submission of display panels received March 3, 2020; and the kit carton layout received March 11, 2020.
CRL_NDA213135_20200313:p1:s34More Complete Response Letters
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