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Home / FDA Updates / New Paragraph IV Certifications as of March 27, 2018

New Paragraph IV Certifications as of March 27, 2018

March 29, 2018

DRUG NAMEDOSAGE FORMSTRENGTHRLDDATE OF SUBMISSION
Halobetasol Propionate New Lotion0.05% Ultavate, 2081831/24/2018
Pregabalin New Extended-release Tablets 330 mg Lyrica CR, 2095011/29/2018
Pregabalin New Extended-release Tablets 82.5 mg and 165 mg Lyrica CR, 209501 2/2/2018 
Tasimelteon New Capsules20 mgHetlioz, 205677 1/31/2018

Click here to view full list of Paragraph IV Certificates filed as of March 27, 2018

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