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Application No Product No Proprietary Name Active Ingredient Dosage Form;Route Strength Company Approval Date RLD Marketing Status TE Code
(ANDA) 203779 001 AMMONIA N 13 AMMONIA N-13 INJECTABLE;INTRAVENOUS 30mCi-300mCi/8ML (3.75-37.5mCi/ML) 3D IMAGING DRUG 2015-10-19 No RX AP
(ANDA) 203778 001 FLUDEOXYGLUCOSE F18 FLUDEOXYGLUCOSE F-18 INJECTABLE;INTRAVENOUS 20-300mCi/ML 3D IMAGING DRUG 2015-10-30 No RX AP
(ANDA) 203777 001 SODIUM FLUORIDE F-18 SODIUM FLUORIDE F-18 INJECTABLE;INTRAVENOUS 10-200mCi/ML 3D IMAGING DRUG 2015-10-19 No RX AP
(NDA) 010375 004 ISOPROTERENOL HYDROCHLORIDE ISOPROTERENOL HYDROCHLORIDE AEROSOL, METERED;INHALATION 0.12MG/INH 3M 1982-01-01 No DISCN
(NDA) 010375 003 MEDIHALER-ISO ISOPROTERENOL SULFATE AEROSOL, METERED;INHALATION 0.08MG/INH 3M 1982-01-01 No DISCN
(NDA) 017027 002 LIPO-HEPIN HEPARIN SODIUM INJECTABLE;INJECTION 5,000 UNITS/0.5ML 3M 1982-01-01 No DISCN
(NDA) 017027 004 LIPO-HEPIN HEPARIN SODIUM INJECTABLE;INJECTION 20,000 UNITS/0.5ML 3M 1982-01-01 No DISCN
(NDA) 017027 011 LIPO-HEPIN HEPARIN SODIUM INJECTABLE;INJECTION 15,000 UNITS/0.5ML 3M 1982-01-01 No DISCN
(NDA) 017027 008 LIPO-HEPIN HEPARIN SODIUM INJECTABLE;INJECTION 5,000 UNITS/ML 3M 1982-01-01 No DISCN
(NDA) 013296 001 DUO-MEDIHALER ISOPROTERENOL HYDROCHLORIDE; PHENYLEPHRINE BITARTRATE AEROSOL, METERED;INHALATION 0.16MG/INH;0.24MG/INH 3M 1982-01-01 No DISCN
(NDA) 017027 010 LIPO-HEPIN HEPARIN SODIUM INJECTABLE;INJECTION 7,500 UNITS/0.5ML 3M 1982-01-01 No DISCN
(NDA) 017027 007 LIPO-HEPIN HEPARIN SODIUM INJECTABLE;INJECTION 20,000 UNITS/ML 3M 1982-01-01 No DISCN
(NDA) 017027 006 LIPO-HEPIN HEPARIN SODIUM INJECTABLE;INJECTION 1,000 UNITS/ML 3M 1982-01-01 No DISCN
(NDA) 010374 003 MEDIHALER-EPI EPINEPHRINE BITARTRATE AEROSOL, METERED;INHALATION 0.3MG/INH 3M 1982-01-01 No DISCN
(NDA) 017518 001 YTTERBIUM YB 169 DTPA PENTETATE CALCIUM TRISODIUM YB-169 INJECTABLE;INJECTION 2mCi/ML 3M 1982-01-01 No DISCN
(NDA) 017832 001 INSTANT MICROSPHERES TECHNETIUM TC-99M ALBUMIN MICROSPHERES KIT INJECTABLE;INJECTION N/A 3M 1982-01-01 No DISCN
(NDA) 012102 001 MEDIHALER ERGOTAMINE ERGOTAMINE TARTRATE AEROSOL, METERED;INHALATION 0.36MG/INH 3M 1982-01-01 No DISCN
(NDA) 017027 009 LIPO-HEPIN HEPARIN SODIUM INJECTABLE;INJECTION 10,000 UNITS/ML 3M 1982-01-01 No DISCN
(NDA) 017027 001 LIPO-HEPIN HEPARIN SODIUM INJECTABLE;INJECTION 1,000 UNITS/0.5ML 3M 1982-01-01 No DISCN
(NDA) 017027 003 LIPO-HEPIN HEPARIN SODIUM INJECTABLE;INJECTION 10,000 UNITS/0.5ML 3M 1982-01-01 No DISCN