FDA Approved Products

Application #TypeSponsorNotesProduct #Drug NameFormStrengthActive IngredientApproval DateMarketing StatusReference Standard
213348ANDASUNSHINE001RIVAROXABANTABLET;ORAL10MGRIVAROXABAN2025-05-14PrescriptionNo
002RIVAROXABANTABLET;ORAL15MGRIVAROXABAN2025-05-14PrescriptionNo
003RIVAROXABANTABLET;ORAL20MGRIVAROXABAN2025-05-14PrescriptionNo
213037ANDASUNSHINE001ARIPIPRAZOLETABLET;ORAL2MGARIPIPRAZOLE2023-10-02PrescriptionNo
002ARIPIPRAZOLETABLET;ORAL5MGARIPIPRAZOLE2023-10-02PrescriptionNo
003ARIPIPRAZOLETABLET;ORAL10MGARIPIPRAZOLE2023-10-02PrescriptionNo
214004ANDASUNSHINE001METOPROLOL SUCCINATETABLET, EXTENDED RELEASE;ORALEQ 50MG TARTRATEMETOPROLOL SUCCINATE2022-09-26PrescriptionNo
002METOPROLOL SUCCINATETABLET, EXTENDED RELEASE;ORALEQ 100MG TARTRATEMETOPROLOL SUCCINATE2022-09-26PrescriptionNo
003METOPROLOL SUCCINATETABLET, EXTENDED RELEASE;ORALEQ 200MG TARTRATEMETOPROLOL SUCCINATE2022-09-26PrescriptionNo
004METOPROLOL SUCCINATETABLET, EXTENDED RELEASE;ORALEQ 25MG TARTRATEMETOPROLOL SUCCINATE2022-09-26PrescriptionNo
214748ANDASUNSHINE001BRIVARACETAMTABLET;ORAL10MGBRIVARACETAM2022-06-09DiscontinuedNo
002BRIVARACETAMTABLET;ORAL25MGBRIVARACETAM2022-06-09DiscontinuedNo
003BRIVARACETAMTABLET;ORAL50MGBRIVARACETAM2022-06-09DiscontinuedNo
004BRIVARACETAMTABLET;ORAL75MGBRIVARACETAM2022-06-09DiscontinuedNo
005BRIVARACETAMTABLET;ORAL100MGBRIVARACETAM2022-06-09DiscontinuedNo
213594ANDASUNSHINE001OSELTAMIVIR PHOSPHATEFOR SUSPENSION;ORALEQ 6MG BASE/MLOSELTAMIVIR PHOSPHATE2022-01-05PrescriptionNo
208335ANDASUNSHINE001LINAGLIPTINTABLET;ORAL5MGLINAGLIPTIN2021-08-31PrescriptionNo
208336ANDASUNSHINE001LINAGLIPTIN AND METFORMIN HYDROCHLORIDETABLET;ORAL2.5MG;500MGLINAGLIPTIN; METFORMIN HYDROCHLORIDE2021-08-30PrescriptionNo
002LINAGLIPTIN AND METFORMIN HYDROCHLORIDETABLET;ORAL2.5MG;850MGLINAGLIPTIN; METFORMIN HYDROCHLORIDE2021-08-30PrescriptionNo
003LINAGLIPTIN AND METFORMIN HYDROCHLORIDETABLET;ORAL2.5MG;1GMLINAGLIPTIN; METFORMIN HYDROCHLORIDE2021-08-30PrescriptionNo
212328ANDASUNSHINE001DULOXETINE HYDROCHLORIDECAPSULE, DELAYED REL PELLETS;ORALEQ 20MG BASEDULOXETINE HYDROCHLORIDE2021-02-11PrescriptionNo
002DULOXETINE HYDROCHLORIDECAPSULE, DELAYED REL PELLETS;ORALEQ 30MG BASEDULOXETINE HYDROCHLORIDE2021-02-11PrescriptionNo
003DULOXETINE HYDROCHLORIDECAPSULE, DELAYED REL PELLETS;ORALEQ 60MG BASEDULOXETINE HYDROCHLORIDE2021-02-11PrescriptionNo
213496ANDASUNSHINE001TADALAFILTABLET;ORAL20MGTADALAFIL2020-11-23PrescriptionNo
213032ANDASUNSHINE001SILDENAFIL CITRATETABLET;ORALEQ 25MG BASESILDENAFIL CITRATE2020-06-11PrescriptionNo
002SILDENAFIL CITRATETABLET;ORALEQ 50MG BASESILDENAFIL CITRATE2020-06-11PrescriptionNo
003SILDENAFIL CITRATETABLET;ORALEQ 100MG BASESILDENAFIL CITRATE2020-06-11PrescriptionNo
213069ANDASUNSHINE001FEBUXOSTATTABLET;ORAL40MGFEBUXOSTAT2020-06-02PrescriptionNo
002FEBUXOSTATTABLET;ORAL80MGFEBUXOSTAT2020-06-02PrescriptionNo
211978ANDASUNSHINE001ENTECAVIRTABLET;ORAL0.5MGENTECAVIR2020-05-20DiscontinuedNo
002ENTECAVIRTABLET;ORAL1MGENTECAVIR2020-05-20DiscontinuedNo
213346ANDASUNSHINE001SOLIFENACIN SUCCINATETABLET;ORAL5MGSOLIFENACIN SUCCINATE2020-04-13DiscontinuedNo
002SOLIFENACIN SUCCINATETABLET;ORAL10MGSOLIFENACIN SUCCINATE2020-04-13DiscontinuedNo
208508ANDASUNSHINE001TICAGRELORTABLET;ORAL90MGTICAGRELOR2020-04-06PrescriptionNo
002TICAGRELORTABLET;ORAL60MGTICAGRELOR2020-04-06PrescriptionNo
210667ANDASUNSHINE001ROSUVASTATIN CALCIUMTABLET;ORALEQ 5MG BASEROSUVASTATIN CALCIUM2020-04-01DiscontinuedNo
002ROSUVASTATIN CALCIUMTABLET;ORALEQ 10MG BASEROSUVASTATIN CALCIUM2020-04-01DiscontinuedNo
003ROSUVASTATIN CALCIUMTABLET;ORALEQ 20MG BASEROSUVASTATIN CALCIUM2020-04-01DiscontinuedNo
004ROSUVASTATIN CALCIUMTABLET;ORALEQ 40MG BASEROSUVASTATIN CALCIUM2020-04-01DiscontinuedNo
211865ANDASUNSHINE001RANOLAZINETABLET, EXTENDED RELEASE;ORAL500MGRANOLAZINE2020-03-23PrescriptionNo
002RANOLAZINETABLET, EXTENDED RELEASE;ORAL1GMRANOLAZINE2020-03-23PrescriptionNo
212739ANDASUNSHINE001OSELTAMIVIR PHOSPHATECAPSULE;ORALEQ 30MG BASEOSELTAMIVIR PHOSPHATE2020-03-04PrescriptionNo
002OSELTAMIVIR PHOSPHATECAPSULE;ORALEQ 45MG BASEOSELTAMIVIR PHOSPHATE2020-03-04PrescriptionNo
003OSELTAMIVIR PHOSPHATECAPSULE;ORALEQ 75MG BASEOSELTAMIVIR PHOSPHATE2020-03-04PrescriptionNo
211335ANDASUNSHINE001TADALAFILTABLET;ORAL2.5MGTADALAFIL2019-03-26PrescriptionNo
002TADALAFILTABLET;ORAL5MGTADALAFIL2019-03-26PrescriptionNo
003TADALAFILTABLET;ORAL10MGTADALAFIL2019-03-26PrescriptionNo
004TADALAFILTABLET;ORAL20MGTADALAFIL2019-03-26PrescriptionNo
211049ANDASUNSHINE001OLMESARTAN MEDOXOMILTABLET;ORAL5MGOLMESARTAN MEDOXOMIL2019-02-22PrescriptionNo
002OLMESARTAN MEDOXOMILTABLET;ORAL20MGOLMESARTAN MEDOXOMIL2019-02-22PrescriptionNo
003OLMESARTAN MEDOXOMILTABLET;ORAL40MGOLMESARTAN MEDOXOMIL2019-02-22PrescriptionNo
209044ANDASUNSHINE001AZITHROMYCINTABLET;ORALEQ 500MG BASEAZITHROMYCIN2018-12-07PrescriptionNo
209045ANDASUNSHINE001AZITHROMYCINTABLET;ORALEQ 250MG BASEAZITHROMYCIN2018-12-07PrescriptionNo
209043ANDASUNSHINE001AZITHROMYCINTABLET;ORALEQ 600MG BASEAZITHROMYCIN2018-12-06PrescriptionNo
206238ANDASUNSHINE001OLANZAPINETABLET;ORAL2.5MGOLANZAPINE2018-11-19DiscontinuedNo
002OLANZAPINETABLET;ORAL5MGOLANZAPINE2018-11-19DiscontinuedNo
003OLANZAPINETABLET;ORAL7.5MGOLANZAPINE2018-11-19DiscontinuedNo
004OLANZAPINETABLET;ORAL10MGOLANZAPINE2018-11-19DiscontinuedNo
005OLANZAPINETABLET;ORAL15MGOLANZAPINE2018-11-19DiscontinuedNo
006OLANZAPINETABLET;ORAL20MGOLANZAPINE2018-11-19DiscontinuedNo
208999ANDASUNSHINE001METFORMIN HYDROCHLORIDETABLET;ORAL500MGMETFORMIN HYDROCHLORIDE2018-10-12DiscontinuedNo
002METFORMIN HYDROCHLORIDETABLET;ORAL850MGMETFORMIN HYDROCHLORIDE2018-10-12DiscontinuedNo
003METFORMIN HYDROCHLORIDETABLET;ORAL1GMMETFORMIN HYDROCHLORIDE2018-10-12DiscontinuedNo
206669ANDASUNSHINE001ENTACAPONETABLET;ORAL200MGENTACAPONE2018-10-03PrescriptionNo
206295ANDASUNSHINE001MOXIFLOXACIN HYDROCHLORIDETABLET;ORALEQ 400MG BASEMOXIFLOXACIN HYDROCHLORIDE2018-09-28DiscontinuedNo
204062ANDASUNSHINE001IBUPROFENTABLET;ORAL400MGIBUPROFEN2018-09-10DiscontinuedNo
002IBUPROFENTABLET;ORAL600MGIBUPROFEN2018-09-10DiscontinuedNo
003IBUPROFENTABLET;ORAL800MGIBUPROFEN2018-09-10DiscontinuedNo
208987ANDASUNSHINE001CLARITHROMYCINTABLET, EXTENDED RELEASE;ORAL500MGCLARITHROMYCIN2018-07-09PrescriptionNo
206524ANDASUNSHINE001AMLODIPINE BESYLATETABLET;ORALEQ 2.5MG BASEAMLODIPINE BESYLATE2018-05-04DiscontinuedNo
002AMLODIPINE BESYLATETABLET;ORALEQ 5MG BASEAMLODIPINE BESYLATE2018-05-04DiscontinuedNo
003AMLODIPINE BESYLATETABLET;ORALEQ 10MG BASEAMLODIPINE BESYLATE2018-05-04DiscontinuedNo