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Last Updated: October 30, 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
Alcon Pharms Ltd NAVSTEL calcium chloride; dextrose; magnesium chloride; oxiglutatione; potassium chloride; sodium bicarbonate; sodium chloride; sodium phosphate SOLUTION;IRRIGATION 022193-001 Jul 24, 2008 DISCN No No   Start Trial   Start Trial Y USE AS AN INTRAOCULAR IRRIGATING SOLUTION DURING SURGICAL PROCEDURES INVOLVING PERFUSION OF THE EYE
Allergan OZURDEX dexamethasone IMPLANT;INTRAVITREAL 022315-001 Jun 17, 2009 RX Yes Yes   Start Trial   Start Trial Y
Cumberland Pharms CALDOLOR ibuprofen SOLUTION;INTRAVENOUS 022348-002 Jun 11, 2009 RX Yes Yes   Start Trial   Start Trial Y MANAGEMENT OF MILD TO MODERATE PAIN, MANAGEMENT OF MODERATE TO SEVERE PAIN AS AN ADJUNCT TO OPIOID ANALGESICS, REDUCTION IN FEVER THROUGH ANTI-INFLAMMATORY, ANALGESIC, AND ANTIPYRETIC ACTIVITY
Cumberland Pharms CALDOLOR ibuprofen SOLUTION;INTRAVENOUS 022348-001 Jun 11, 2009 DISCN No No   Start Trial   Start Trial Y MANAGEMENT OF MILD TO MODERATE PAIN, MANAGEMENT OF MODERATE TO SEVERE PAIN AS AN ADJUNCT TO OPIOID ANALGESICS, REDUCTION IN FEVER THROUGH ANTI-INFLAMMATORY, ANALGESIC, AND ANTIPYRETIC ACTIVITY
Sanofi Aventis Us CHILDREN'S ALLEGRA HIVES fexofenadine hydrochloride TABLET, ORALLY DISINTEGRATING;ORAL 021909-003 Jan 24, 2011 DISCN Yes No   Start Trial   Start Trial Y
Sanofi Aventis Us CHILDREN'S ALLEGRA ALLERGY fexofenadine hydrochloride TABLET, ORALLY DISINTEGRATING;ORAL 021909-002 Jan 24, 2011 DISCN Yes No   Start Trial   Start Trial Y RELIEF OF SYMPTOMS ASSOCIATED WITH RESPIRATORY ALLERGIES ADULTS AND CHILDREN 6 YEARS OF AGE AND OLDER
>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:

Moodys
Harvard Business School
Colorcon
Express Scripts
Dow
Mallinckrodt

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