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Last Updated: July 16, 2024

Regulatory Exclusivity: NEW STRENGTH


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Drugs with New Strength Regulatory Exclusivity

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Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Exclusivity Expiration Patented / Exclusive Use
Am Regent INJECTAFER ferric carboxymaltose SOLUTION;INTRAVENOUS 203565-003 Apr 28, 2021 RX Yes Yes ⤷  Sign Up NEW STRENGTH
Teva Pharm ARMONAIR RESPICLICK fluticasone propionate POWDER;INHALATION 208798-007 Jul 9, 2021 DISCN Yes No ⤷  Sign Up NEW STRENGTH
Janssen Pharms INVEGA HAFYERA paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 207946-005 Aug 30, 2021 RX Yes No ⤷  Sign Up NEW STRENGTH
Janssen Pharms INVEGA HAFYERA paliperidone palmitate SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 207946-006 Aug 30, 2021 RX Yes No ⤷  Sign Up NEW STRENGTH
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Exclusivity Expiration >Patented / Exclusive Use

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