Inactive Ingredient Search for Approved Drug Products

You are Searching: Change and Deletion by Inactive Ingredient Name Beginning with O

Quarter Inactive Ingredient Route of Administration Dosage Form Maximum Potency per unit dose Maximum Daily Exposure Status
5607 Q3 2021 OPADRY YS-1-8325 BEIGE ORAL TABLET 48 mg Correction
5607 Q4 2021 OPADRY YS-1-8325 BEIGE ORAL TABLET 16.00 mg Correction
5003 Q3 2021 OLEIC ACID ORAL TABLET, EXTENDED RELEASE 2.00 mg MDE Replacement
5003 Q4 2021 OLEIC ACID ORAL TABLET, EXTENDED RELEASE 2.95 mg MDE Replacement
5007 Q3 2021 OLEIC ACID TOPICAL GEL, METERED 2.50 %w/w MDE Replacement
5007 Q4 2021 OLEIC ACID TOPICAL GEL, METERED 87.5 mg MDE Replacement
5127 Q3 2021 OPADRY 03B58902 WHITE ORAL TABLET 10.50 mg MDE Replacement
5127 Q4 2021 OPADRY 03B58902 WHITE ORAL TABLET 21 mg MDE Replacement
5136 Q3 2021 OPADRY 03F14895 PINK ORAL TABLET, FILM COATED 4.00 mg MDE Replacement
5136 Q4 2021 OPADRY 03F14895 PINK ORAL TABLET, FILM COATED 8 mg MDE Replacement
5139 Q3 2021 OPADRY 03F59016 CLEAR ORAL TABLET, EXTENDED RELEASE 4.00 mg MDE Replacement
5139 Q4 2021 OPADRY 03F59016 CLEAR ORAL TABLET, EXTENDED RELEASE 8 mg MDE Replacement
5185 Q3 2021 OPADRY AMB 80W68912 WHITE ORAL TABLET, EXTENDED RELEASE 36.00 mg MDE Replacement
5185 Q4 2021 OPADRY AMB 80W68912 WHITE ORAL TABLET, EXTENDED RELEASE 72 mg MDE Replacement
5186 Q3 2021 OPADRY AMB 80W68912 WHITE ORAL TABLET, FILM COATED 18.00 mg MDE Replacement
5186 Q4 2021 OPADRY AMB 80W68912 WHITE ORAL TABLET, FILM COATED 18 mg MDE Replacement
5207 Q3 2021 OPADRY II 33G28707 WHITE ORAL TABLET, EXTENDED RELEASE 30.00 mg MDE Replacement
5207 Q4 2021 OPADRY II 33G28707 WHITE ORAL TABLET, EXTENDED RELEASE 60 mg MDE Replacement
5221 Q3 2021 OPADRY II 49B10882 BLUE ORAL TABLET 26.90 mg MDE Replacement
5221 Q4 2021 OPADRY II 49B10882 BLUE ORAL TABLET 53.8 mg MDE Replacement
5236 Q3 2021 OPADRY II 85F18422 WHITE ORAL TABLET, EXTENDED RELEASE 51.30 mg MDE Replacement
5236 Q4 2021 OPADRY II 85F18422 WHITE ORAL TABLET, EXTENDED RELEASE 72 mg MDE Replacement
5345 Q3 2021 OPADRY OY-58900 WHITE ORAL TABLET 31.80 mg MDE Replacement
5345 Q4 2021 OPADRY OY-58900 WHITE ORAL TABLET 132 mg MDE Replacement
5346 Q3 2021 OPADRY OY-58900 WHITE ORAL TABLET, FILM COATED 16.25 mg MDE Replacement
5346 Q4 2021 OPADRY OY-58900 WHITE ORAL TABLET, FILM COATED 65 mg MDE Replacement
5410 Q3 2021 OPADRY Y-5-7068 WHITE ORAL TABLET 120.00 mg MDE Replacement
5410 Q4 2021 OPADRY Y-5-7068 WHITE ORAL TABLET 290.25 mg MDE Replacement
5559 Q3 2021 OPADRY YS-1-7003 WHITE ORAL TABLET 147.80 mg MDE Replacement
5559 Q4 2021 OPADRY YS-1-7003 WHITE ORAL TABLET 402.84 mg MDE Replacement
5571 Q3 2021 OPADRY YS-1-7006 CLEAR ORAL TABLET 56.05 mg MDE Replacement
5571 Q4 2021 OPADRY YS-1-7006 CLEAR ORAL TABLET 111.24 mg MDE Replacement
5590 Q3 2021 OPADRY YS-1-7472 CLEAR ORAL CAPSULE, EXTENDED RELEASE 50.76 mg MDE Replacement
5590 Q4 2021 OPADRY YS-1-7472 CLEAR ORAL CAPSULE, EXTENDED RELEASE 50.76 mg MDE Replacement
5611 Q3 2021 OPADRY YS-1R-7006 CLEAR ORAL TABLET 26.25 mg MDE Replacement
5611 Q4 2021 OPADRY YS-1R-7006 CLEAR ORAL TABLET 37.54 mg MDE Replacement
5459 Q4 2021 OPADRY YS-1-14142 PINK ORAL TABLET, FILM COATED, EXTENDED RELEASE 16.00 mg 26.8 mg Deletion
5616 Q4 2021 OPADRY YS-2-19114A CLEAR ORAL TABLET, EXTENDED RELEASE 1.50 mg Deletion
5645 Q4 2021 OPALUX AS 2553 ORANGE ORAL TABLET NA Deletion
5654 Q4 2021 OPALUX AS 5034 RED ORAL TABLET, COATED 0.02 mg Deletion

 

 

FDA/Center for Drug Evaluation and Research
Office of Pharmaceutical Quality
Office of Policy for Pharmaceutical Quality
Mailbox for IID corrections IIDUpdate@fda.hhs.gov
Update Frequency: Quarterly

Data Through: September 30, 2021
Database Last Updated: October 21, 2021

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