On December 16, 2016 FDA has announced that it received Abbreviated New Drug Application’s (ANDA; U.S.C. § 355(j)(2)(A)(vii)(IV)) containing a “Paragraph IV” patent certification for the following drugs.
|Drug Name||Dosage Form||Strength||RLD||Date of Submission|
|Aspirin and Omeprazole||Delayed-release Tablets||81 mg/40 mg and 325 mg/40 mg||Yosprala||10/13/2016|
|Buprenorphine Hydrochloride||Buccal Film||75 mcg and 150 mcg||Belbuca||10/24/2016|
|Treprostinil||Extended-release Tablets||0.25 mg and 1 mg||Orenitram||5/19/2016|