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The status of these postmarketing studies must be reported annually according to 21 CFR 314. 81 and section 505B a 3 B of the FDCA. Fda.gov/AboutFDA/CentersOffices/CDER/ucm090142. htm. EXPIRY DATING PERIOD A 24-month expiry dating period is granted for Tivorbex both dosage strengths in all presentations when stored at 25 C 77 F with excursions permitted from 15 to 30 C 59 to 86 F. Vice President Regulatory Affairs Quality Dear Mr. Jensen Please refer to your New Drug Application NDA dated...
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