Paragraph IV Challenges
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Tradename | Dosage | Generic Name | NDA | ANDAs Submitted | 180 Day Exclusivity Status | Submissiondate |
---|---|---|---|---|---|---|
RETEVMO | Capsules | selpercatinib | 213246 | 1 | 2024-05-08 | |
TABRECTA | Tablets | capmatinib hydrochloride | 213591 | 1 | 2024-05-06 | |
PEMAZYRE | Tablets | pemigatinib | 213736 | 1 | 2024-04-17 | |
OZEMPIC | Injection | semaglutide | 209637 | 1 | 2024-04-11 | |
HETLIOZ LQ | Oral Suspension | tasimelteon | 214517 | 1 | 2024-04-01 | |
ADVIL DUAL ACTION WITH ACETAMINOPHEN | Tablets | acetaminophen; ibuprofen | 211733 | 2 | Eligible | 2024-03-28 |
XCOPRI | Tablets | cenobamate | 212839 | 2 | 2024-03-11 | |
>Tradename | >Dosage | >Generic Name | >NDA | >ANDAs Submitted | >180 Day Exclusivity Status | >Submissiondate |