New Paragraph IV Certifications as of May 22, 2018
DRUG NAME | DOSAGE FORM | STRENGTH | RLD | DATE OF SUBMISSION |
---|---|---|---|---|
Apremilast | Tablets | 10 mg, 20 mg and 30 mg | Otezla, 205437 | 3/22/2018 |
Linagliptin and Metformin Hydrochloride | Extended-release Tablets | 2.5 mg/1000 mg 5 mg/1000 mg | Jentadueto XR, 208026 | 3/28/2018 |
Tolvaptan | Tablets | 60 mg | Samsca, 22275 | 3/26/2018 |
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