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50 mg acetaminophen USP. 325 mg caffeine USP. 40 mg codeine phosphate USP. 30 mg 5-allyl-5-isobutylbarbituric acid is a short- to intermediate-acting barbiturate. Several cases of dermatological reactions including toxic epidermal necrolysis and erythema multiforme have been reported for Acetaminophen and Caffeine Tablets USP. Page 7 The prevalence of this CYP2D6 phenotype varies widely and has been estimated at 0. 5 to 1 in Chinese and Japanese 0. Carcinogenesis Mutagenesis Impairment of...
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NDA 20-232s-021 is a form used for submitting a new drug application to the FDA.
Pharmaceutical companies seeking FDA approval for a new drug must file NDA 20-232s-021.
NDA 20-232s-021 must be filled out following FDA guidelines and including all relevant information about the new drug.
The purpose of NDA 20-232s-021 is to provide the FDA with detailed information about a new drug in order to evaluate its safety and efficacy.
NDA 20-232s-021 must include information about the drug's composition, manufacturing process, clinical trials, and proposed labeling.
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