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Last Updated: October 7, 2024

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Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Agios Pharms Inc PYRUKYND mitapivat sulfate TABLET;ORAL 216196-001 Feb 17, 2022 RX Yes No ⤷  Sign Up ⤷  Sign Up METHOD FOR ADMINISTERING MITAPIVAT OR A SALT OF MITAPIVAT TO MITIGATE DRUG INTERACTIONS IN PATIENTS WITH HEMOLYTIC ANEMIA THAT ARE TAKING MODERATE CYP3A INDUCERS
Agios Pharms Inc PYRUKYND mitapivat sulfate TABLET;ORAL 216196-002 Feb 17, 2022 RX Yes No ⤷  Sign Up ⤷  Sign Up METHOD FOR ADMINISTERING MITAPIVAT OR A SALT OF MITAPIVAT TO MITIGATE DRUG INTERACTIONS IN PATIENTS WITH HEMOLYTIC ANEMIA THAT ARE TAKING MODERATE CYP3A INDUCERS
Agios Pharms Inc PYRUKYND mitapivat sulfate TABLET;ORAL 216196-003 Feb 17, 2022 RX Yes Yes ⤷  Sign Up ⤷  Sign Up METHOD FOR ADMINISTERING MITAPIVAT OR A SALT OF MITAPIVAT TO MITIGATE DRUG INTERACTIONS IN PATIENTS WITH HEMOLYTIC ANEMIA THAT ARE TAKING MODERATE CYP3A INDUCERS
Tris Pharma Inc ONYDA XR clonidine hydrochloride SUSPENSION, EXTENDED RELEASE;ORAL 217645-001 May 24, 2024 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y METHOD FOR DELIVERING AN EFFECTIVE AMOUNT OF CLONIDINE FOR A 24-HOUR PERIOD USING A SINGLE ORAL CLONIDINE COMPOSITION ACCORDING TO CLAIM 1 PRIOR TO BED TIME
Novartis FABHALTA iptacopan hydrochloride CAPSULE;ORAL 218276-001 Dec 5, 2023 RX Yes Yes ⤷  Sign Up ⤷  Sign Up TREATMENT OF PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) BY ADMINISTRATION OF 200 MG OF IPTACOPAN TWICE DAILY
Haleon Us Holdings ADVIL DUAL ACTION WITH ACETAMINOPHEN acetaminophen; ibuprofen TABLET;ORAL 211733-001 Feb 28, 2020 OTC Yes Yes ⤷  Sign Up ⤷  Sign Up Y
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use

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