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Last Updated: October 24, 2020

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Regulatory Exclusivity: NEW DOSAGE FORM

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Drugs with New Dosage Form Regulatory Exclusivity

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Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Exclusivity Expiration Patented / Exclusive Use
Eyevance ZERVIATE cetirizine hydrochloride SOLUTION/DROPS;OPHTHALMIC 208694-001 May 30, 2017 RX Yes Yes   Start Trial NEW DOSAGE FORM
Mayne Pharma LEXETTE halobetasol propionate AEROSOL, FOAM;TOPICAL 210566-001 May 24, 2018 RX Yes Yes   Start Trial NEW DOSAGE FORM
Dow Pharm ALTRENO tretinoin LOTION;TOPICAL 209353-001 Aug 23, 2018 RX Yes Yes   Start Trial NEW DOSAGE FORM
Mc2 WYNZORA betamethasone dipropionate; calcipotriene CREAM;TOPICAL 213422-001 Jul 20, 2020 RX Yes Yes   Start Trial NEW DOSAGE FORM
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Exclusivity Expiration >Patented / Exclusive Use

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Serving leading biopharmaceutical companies globally:

Dow
McKinsey
Boehringer Ingelheim
Moodys
Medtronic
Johnson and Johnson

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