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City Gel / / Company Benzoyl Peroxide Combination Dow Pharmaceutical Sciences Inc. / / Country United States / / Event FDA Phase / Product Issues / / Facility Laboratory Findings / / IndustryTerm prescription BPO/clindamycin combination products / peroxide combination drug product / clindamycin/ BPO drug products / combination drug product / drug product / clindamycin/BPO topical products / proposed drug product / combination dyad product / chemical name / combination product / peroxide product / marketed topical combination product / hydroxyl / prescription clindamycin topical products / topical combination drug product / nonprescription BPO products / fixed combination product / combination products / drug products / / MedicalCondition significant diarrhea / tumor / Proposed Indications Acne / cancer / acne / severe colitis / anaphylaxis / allergy / colitis / severe acne vulgaris / acne vulgaris / chronic disease / common skin disease / diarrhea / bloody diarrhea / pseudomembranous colitis / / MedicalTreatment medication errors / CPR / antibiotics / / Organization Advisory Committee / / Person Brenda E. Vaughan / / Product Clindamycin Phosphate / Pharmacological / Duac / Clindagel / erythromycin / BenzaClin / DPS-07-12 / application / clindamycin / EOP2 / Acanya / DPSI-06-22 / Acanya Gel / / Technology Pharmacokinetics / Pharmacodynamics / /
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CLINICAL REVIEW Application Type NDA Submission Number[removed]Submission Code 0000