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Approved Drug Products containing 21022 listed in the FDA Orange Book. Original Data : FDA Website

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01 VALEANT BERMUDA (1)

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01 SOLUTION;TOPICAL (1)

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01 DISCN (1)

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01 PENLAC (1)

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01 Yes (1)

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SOLUTION; TOPICAL
8% **Federal Regis...
1999-12-17
21022
PENLAC
DISCN
Yes
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Looking for FDA Orange Book APPLICATION 21022

Looking for FDA Orange Book APPLICATION 21022 1

19

Bausch Health, based in Canada, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is CICLOPIROX, with a corresponding application number 21022.

Regulatory Information DISCN

With a dosage strength 8% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Dosage Form Route SOLUTION; TOPICAL

Reference Listed Drug Yes

Approved since 1999-12-17

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