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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) 091195 003 TACROLIMUS TACROLIMUS CAPSULE;ORAL EQ 5MG BASE ACCORD HLTHCARE 2011-08-31 No RX BX
(NDA) 021438 001 INNOPRAN XL PROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 80MG ANI PHARMS 2003-03-12 Yes RX BX
(ANDA) 208833 004 CELECOXIB CELECOXIB CAPSULE;ORAL 400MG AMNEAL PHARMS 2018-05-31 No RX BX
(ANDA) 210339 003 PROPAFENONE HYDROCHLORIDE PROPAFENONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 425MG SINOTHERAPEUTICS INC 2019-01-04 No RX BX
(ANDA) 086457 001 EPIFOAM HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE AEROSOL, METERED;TOPICAL 1%;1% MYLAN SPECIALITY LP 1982-01-01 No RX BX
(ANDA) 091195 002 TACROLIMUS TACROLIMUS CAPSULE;ORAL EQ 1MG BASE ACCORD HLTHCARE 2011-08-31 No RX BX
(ANDA) 210339 002 PROPAFENONE HYDROCHLORIDE PROPAFENONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 325MG SINOTHERAPEUTICS INC 2019-01-04 No RX BX
(ANDA) 075953 001 TERCONAZOLE TERCONAZOLE CREAM;VAGINAL 0.8% TARO 2004-04-06 No RX BX
(ANDA) 076263 001 DIFLORASONE DIACETATE DIFLORASONE DIACETATE CREAM;TOPICAL 0.05% ANI PHARMS 2002-12-20 No RX BX
(NDA) 021735 001 TERCONAZOLE TERCONAZOLE CREAM;VAGINAL 0.8% FOUGERA PHARMS INC 2004-10-01 Yes RX BX
(ANDA) 075508 001 DIFLORASONE DIACETATE DIFLORASONE DIACETATE CREAM;TOPICAL 0.05% TARO 2000-04-24 No RX BX
(ANDA) 208833 002 CELECOXIB CELECOXIB CAPSULE;ORAL 100MG AMNEAL PHARMS 2018-05-31 No RX BX
(NDA) 021438 002 INNOPRAN XL PROPRANOLOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 120MG ANI PHARMS 2003-03-12 Yes RX BX
(ANDA) 086195 001 PROCTOFOAM HC HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE AEROSOL, METERED;TOPICAL 1%;1% MYLAN SPECIALITY LP 1982-01-01 Yes RX BX
(ANDA) 210339 001 PROPAFENONE HYDROCHLORIDE PROPAFENONE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 225MG SINOTHERAPEUTICS INC 2019-01-04 No RX BX
(ANDA) 091195 001 TACROLIMUS TACROLIMUS CAPSULE;ORAL EQ 0.5MG BASE ACCORD HLTHCARE 2011-08-31 No RX BX
(NDA) 050625 003 SANDIMMUNE CYCLOSPORINE CAPSULE;ORAL 50MG NOVARTIS 1992-11-23 Yes RX BX
(ANDA) 208833 003 CELECOXIB CELECOXIB CAPSULE;ORAL 200MG AMNEAL PHARMS 2018-05-31 No RX BX
(NDA) 020983 001 VENTOLIN HFA ALBUTEROL SULFATE AEROSOL, METERED;INHALATION EQ 0.09MG BASE/INH GLAXOSMITHKLINE 2001-04-19 Yes RX BX
(ANDA) 208833 001 CELECOXIB CELECOXIB CAPSULE;ORAL 50MG AMNEAL PHARMS 2018-05-31 No RX BX