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Last Updated: September 20, 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 022399-001 Apr 6, 2011 RX Yes Yes   Start Trial   Start Trial Y Y 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 Y Y MANAGEMENT OF POSTHERPETIC NEURALGIA (PHN) IN ADULTS
Pf Prism Cv CHANTIX varenicline tartrate TABLET;ORAL 021928-002 May 10, 2006 RX Yes Yes   Start Trial   Start Trial Y
Pf Prism Cv CHANTIX varenicline tartrate TABLET;ORAL 021928-001 May 10, 2006 RX Yes No   Start Trial   Start Trial Y
Bausch XERESE acyclovir; hydrocortisone CREAM;TOPICAL 022436-001 Jul 31, 2009 RX Yes Yes   Start Trial   Start Trial Y COMBINATION PRODUCT FOR THE EARLY TREATMENT OF RECURRENT HERPES LABIALIS (COLD SORES) TO REDUCE THE LIKELIHOOD OF ULCERATIVE COLD SORES AND TO SHORTEN THE LESION HEALING TIME IN ADULTS AND CHILDREN (6 YEARS OF AGE AND OLDER)
Bausch XERESE acyclovir; hydrocortisone CREAM;TOPICAL 022436-001 Jul 31, 2009 RX Yes Yes   Start Trial   Start Trial Y NEW COMBINATION PRODUCT FOR THE EARLY TREATMENT OF RECURRENT HERPES LABIALIS (COLD SORES) TO REDUCE THE LIKELIHOOD OF ULCERATIVE COLD SORES AND TO SHORTEN THE LESION HEALING TIME IN ADULTS AND ADOLESCENTS (12 YEARS OF AGE AND OLDER)
Sucampo Pharma Llc AMITIZA lubiprostone CAPSULE;ORAL 021908-001 Jan 31, 2006 RX Yes Yes   Start Trial   Start Trial Y USE IN RELIEVING OR PREVENTING CONSTIPATION IN A PATIENT WITH OPIOID-INDUCED CONSTIPATION WITH A DOSAGE UNIT COMPRISING 24MICROG +/- 10% OF A DRUG SUBSTANCE AND A PHARMACEUTICALLY SUITABLE EXCIPIENT
>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:

McKesson
Harvard Business School
Baxter
Medtronic
Merck
Johnson and Johnson

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