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Last Updated: October 1, 2020

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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
Arbor Pharms Llc HORIZANT gabapentin enacarbil TABLET, EXTENDED RELEASE;ORAL 022399-002 Dec 13, 2011 RX Yes No   Start Trial   Start Trial MANAGEMENT OF POSTHERPETIC NEURALGIA (PHN) IN ADULTS
Arbor Pharms Llc HORIZANT gabapentin enacarbil TABLET, EXTENDED RELEASE;ORAL 022399-002 Dec 13, 2011 RX Yes No   Start Trial   Start Trial TREATMENT OF MODERATE-TO-SEVERE PRIMARY RESTLESS LEG SYNDROME IN ADULTS
Arbor Pharms Llc HORIZANT gabapentin enacarbil TABLET, EXTENDED RELEASE;ORAL 022399-001 Apr 6, 2011 RX Yes Yes   Start Trial   Start Trial TREATMENT OF MODERATE-TO-SEVERE PRIMARY RESTLESS LEG SYNDROME IN ADULTS
Arbor Pharms Llc HORIZANT gabapentin enacarbil TABLET, EXTENDED RELEASE;ORAL 022399-001 Apr 6, 2011 RX Yes Yes   Start Trial   Start Trial MANAGEMENT OF POSTHERPETIC NEURALGIA (PHN) IN ADULTS
Bausch LOCOID hydrocortisone butyrate LOTION;TOPICAL 022076-001 May 18, 2007 AB RX Yes Yes   Start Trial   Start Trial Y
Kyowa Kirin SANCUSO granisetron FILM, EXTENDED RELEASE;TRANSDERMAL 022198-001 Sep 12, 2008 RX Yes Yes   Start Trial   Start Trial Y USE OF GRANISETRON TRANSDERMAL SYSTEM TO TREAT/PREVENT CHEMOTHERAPY INDUCED NAUSEA AND VOMITING
Otsuka ABILIFY aripiprazole INJECTABLE;INTRAMUSCULAR 021866-001 Sep 20, 2006 DISCN No No   Start Trial   Start Trial 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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Serving leading biopharmaceutical companies globally:

AstraZeneca
Medtronic
McKesson
Colorcon
Moodys
Baxter

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