Approved Drug Product List - Orange Book Reference Listed Drugs by ANDA Reference Standard List. April 2017 Page 1 of 6

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Vivian Williams
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1 April 2017 Page 1 of 6 DESCRIPTION This list refers to drug products approved under an Abbreviated New Drug Application (ANDA) that FDA has selected as reference standards and the associated reference listed drugs (RLDs). The purpose of this list is to assist applicants submitting an ANDA to seek approval of a generic drug in identifying an RLD when an ANDA RS has been selected. If the applicant has a question about which listed drug it should refer to as the RLD, the applicant may consult with FDA (refer to section 1.4 Reference Listed Drug and Reference Standard of the Orange Book Preface for more information). This list is updated monthly. Information in this list is sorted by Active Ingredient(s), Dosage Form, Route, Trade Name, Applicant Name and Strength. Additional information included are marketing status (, OTC, DISCN), Application Number, Product Number, and approval date of the Reference Standard.

2 April 2017 Page 2 of 6 ADAPALENE SOLUTION;TOPICAL ADAPALENE CALL INC 0.1% A Jan 05, 2016 RLD: N AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE SANDOZ 200MG A Dec 23, 1998 RLD: N AMOXICILLIN TABLET, CHEWABLE;ORAL AMOXICILLIN TEVA 250MG A Dec 22, 1992 RLD: N AMOXICILLIN; CLAVULANATE POTASSIUM AMOXICILLIN AND CLAVULANATE POTASSIUM SANDOZ SANDOZ INC 250MG;EQ 125MG BASE 500MG;EQ 125MG BASE A A Aug 23, 2005 Nov 27, 2002 RLD: N RLD: N ARIPIPRAZOLE ARIPIPRAZOLE AMNEAL PHARMS 1MG/ML A Aug 14, 2015 RLD: N ATORVASTATIN CALCIUM; EZETIMIBE EZETIMIBE AND ATORVASTATIN CALCIUM WATSON LABS TEVA EQ 80MG BASE;10MG A Apr 26, 2017 RLD: N253 BISOPROLOL FUMARATE BISOPROLOL FUMARATE MYLAN 10MG A Dec 14, 2005 RLD: N BROMFENAC SODIUM SOLUTION/DROPS;OPHTHALMIC BROMFENAC SODIUM APOTEX INC EQ 0.09% ACID A Jun 19, 2014 RLD: N BROMOCRIPTINE MESYLATE BROMOCRIPTINE MESYLATE MYLAN EQ 5MG BASE A Apr 04, 2005 RLD: N BROMOCRIPTINE MESYLATE PADDOCK LLC EQ 2.5MG BASE A Oct 01, 2008 RLD: N BUPROPION HYDROCHLORIDE BUPROPION HYDROCHLORIDE APOTEX INC 100MG A Jan 17, 2006 RLD: N CALCITONIN SALMON SPRAY, METERED;NASAL CALCITONIN-SALMON APOTEX INC 200 IU/SPRAY A Nov 17, 2008 RLD: N CETIRIZINE HYDROCHLORIDE SYRUP;ORAL CETIRIZINE HYDROCHLORIDE PERRIGO R AND D 5MG/5ML A Jun 17, 2008 RLD: N020346

3 April 2017 Page 3 of 6 CHLORZOXAZONE CHLORZOXAZONE MIKART INC 250MG A Jun 24, 2016 RLD: N CIPROFLOXACIN CIPROFLOXACIN CLARIS 200MG/20ML (10MG/ML) A Apr 29, 2008 RLD: N MG/40ML (10MG/ML) A Apr 29, 2008 RLD: N CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER HOSPIRA 200MG/100ML A Mar 18, 2008 RLD: N MG/200ML A Mar 18, 2008 RLD: N CLOBETASOL PROPIONATE OINTMENT;TOPICAL CLOBETASOL PROPIONATE FOUGERA PHARMS 0.05% A Feb 23, 1996 RLD: N DACARBAZINE DACARBAZINE FRESENIUS KABI USA 100MG/VIAL A Aug 27, 1999 RLD: N MG/VIAL A Aug 27, 1999 RLD: N DESOGESTREL; ETHINYL ESTRADIOL -28 DESOGESTREL AND ETHINYL ESTRADIOL DURAMED PHARMS 0.15MG;0.03MG A Aug 12, 1999 RLD: N BARR DICLOFENAC SODIUM TABLET, EXTENDED RELEASE;ORAL DICLOFENAC SODIUM DEXCEL LTD 100MG A Nov 06, 2002 RLD: N DICYCLOMINE HYDROCHLORIDE SYRUP;ORAL DICYCLOMINE HYDROCHLORIDE MIKART 10MG/5ML A Mar 24, 2005 RLD: N DOCETAXEL DOCETAXEL JIANGSU HENGRUI 40MG/ML A Feb 15, 2017 RLD: N MED FAMCICLOVIR FAMCICLOVIR TEVA PHARMS 500MG A Aug 24, 2007 RLD: N FLUCONAZOLE FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER HOSPIRA 200MG/100ML (2MG/ML) A Jul 29, 2004 RLD: N MG/200ML (2MG/ML) A Jul 29, 2004 RLD: N FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER ACS DOBFAR INFO SA 200MG/100ML (2MG/ML) A Jul 30, 2009 RLD: N MG/200ML (2MG/ML) A Jul 30, 2009 RLD: N FLUDEOXYGLUCOSE F-18 INJECTABLE;INTRAVENOUS FLUDEOXYGLUCOSE F18 QUEEN HAMAMATSU mCi/ML A Aug 31, 2015 RLD: N PET

4 April 2017 Page 4 of 6 FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE MYLAN EQ 20MG BASE A Aug 02, 2 RLD: N GALANTAMINE HYDROBROMIDE GALANTAMINE HYDROBROMIDE WEST-WARD PHARMS INT 4MG/ML A Jan 30, 2009 RLD: N GLIMEPIRIDE; ROSIGLITAZONE MALEATE ROSIGLITAZONE MALEATE AND GLIMEPIRIDE TEVA PHARMS USA 1MG;4MG A Apr 01, 2016 RLD: N GLYCOPYRROLATE GLYCOPYRROLATE HIKMA FARMACEUTICA 0.2MG/ML A Sep 21, 2011 RLD: N HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TEVA 25MG;15MG A Mar 07, 2007 RLD: N IMIPRAMINE PAMOATE IMIPRAMINE PAMOATE WEST-WARD PHARMS INT ISOSULFAN BLUE ISOSULFAN BLUE MYLAN INSTITUTIONAL EQ 75MG HCL A Apr 16, 2010 RLD: N % A Jul 20, 2010 RLD: N KETOTIFEN FUMARATE SOLUTION/DROPS;OPHTHALMIC KETOTIFEN FUMARATE OTC ALCON PHARMS LTD EQ 0.025% BASE A Sep 02, 2008 RLD: N LACTULOSE LACTULOSE HI TECH PHARMA 10GM/15ML A Jul 03, 1995 RLD: N LEVOFLOXACIN LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER ACS DOBFAR INFO SA EQ 250MG/50ML (EQ 5MG/ML) EQ 500MG/100ML (EQ 5MG/ML) EQ 750MG/150ML (EQ 5MG/ML) A A A Jul 07, 2011 Jul 07, 2011 Jul 07, 2011 RLD: N RLD: N RLD: N LEVONORGESTREL LEVONORGESTREL PERRIGO R AND D 0.75MG A Dec 30, 2010 RLD: N OTC 0.75MG A Dec 30, 2010 RLD: N LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE VISCOUS VINTAGE 2% A Feb 27, 2007 RLD: N009470

5 April 2017 Page 5 of 6 LOPERAMIDE HYDROCHLORIDE LOPERAMIDE HYDROCHLORIDE MYLAN 2MG A Sep 18, 1991 RLD: N LOPERAMIDE HYDROCHLORIDE; SIMETHICONE TABLET, CHEWABLE;ORAL LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE OTC PERRIGO 2MG;125MG A Aug 30, 2002 RLD: N MEFLOQUINE HYDROCHLORIDE MEFLOQUINE HYDROCHLORIDE BARR 250MG A Dec 29, 2003 RLD: N METHSCOPOLAMINE BROMIDE METHSCOPOLAMINE BROMIDE VINTAGE PHARMS 2.5MG A Dec 28, 2006 RLD: N MG A Dec 28, 2006 RLD: N METHYLERGONOVINE MALEATE METHYLERGONOVINE MALEATE NOVEL LABS INC 0.2MG A May 02, 2011 RLD: N METHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL METHYLPHENIDATE HYDROCHLORIDE MAYNE PHARMA 60MG A Jun 23, 2016 RLD: N TABLET, CHEWABLE;ORAL METHYLPHENIDATE HYDROCHLORIDE NOVEL LABS INC 10MG A Feb 25, 2015 RLD: N MOEXIPRIL HYDROCHLORIDE MOEXIPRIL HYDROCHLORIDE TEVA 15MG A May 08, 2003 RLD: N NALTREXONE HYDROCHLORIDE NALTREXONE HYDROCHLORIDE MALLINCKRODT 50MG A Mar 22, 2002 RLD: N NIZATIDINE NIZATIDINE AMNEAL PHARMS 15MG/ML A Nov 18, 2009 RLD: N OFLOXACIN SOLUTION/DROPS;OTIC OFLOXACIN BAUSCH AND LOMB 0.3% A Mar 17, 2008 RLD: N OMEPRAZOLE CAPSULE, DELAYED REL PELLETS;ORAL OMEPRAZOLE SANDOZ 20MG A Jan 28, 2003 RLD: N MG A Jan 21, 2009 RLD: N OXALIPLATIN INJECTABLE;IV (INFUSION) OXALIPLATIN QILU PHARM CO LTD 200MG/40ML (5MG/ML) A Jun 07, 2016 RLD: N021759

6 April 2017 Page 6 of 6 PARICALCITOL PARICALCITOL TEVA PHARMS USA 4MCG A Sep 27, 2013 RLD: N PENTOXIFYLLINE TABLET, EXTENDED RELEASE;ORAL PENTOXIFYLLINE APOTEX 400MG A Jun 09, 1999 RLD: N PHENTERMINE HYDROCHLORIDE LOMAIRA AVANTHI INC 8MG A Sep 12, 2016 RLD: N TERBUTALINE SULFATE TERBUTALINE SULFATE LANNETT 5MG A Mar 25, 2005 RLD: N THIOTHIXENE THIOTHIXENE MYLAN 5MG A Jun 23, 1987 RLD: N TIMOLOL MALEATE SOLUTION/DROPS;OPHTHALMIC TIMOLOL MALEATE SANDOZ INC EQ 0.25% BASE EQ 0.5% BASE A A Apr 28, 1995 Apr 28, 1995 RLD: N RLD: N VERAPAMIL HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL VERAPAMIL HYDROCHLORIDE GLENMARK GENERICS 180MG A Aug 03, 2011 RLD: N019152

Ultra Chiron Pharmaceuticals Pvt.Ltd. 575, Phase-IX Industrial Area, Mohali

Ultra Chiron Pharmaceuticals Pvt.Ltd. 575, Phase-IX Industrial Area, Mohali Tablet Section:- 1. ACEPRIL-A Rampril B.P. 2.5mg 2X5X10 Amlodipine Besylate Eq to Amlodipine 5mg Each uncoated Tablet contains 2. ACEPRIL-2.5 Rampril B.P. 2.5mg 2X5X10 Each uncoated Tablet contains 3.