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Application No	Product No	Proprietary Name	Active Ingredient	Dosage Form;Route	Strength	Company	Approval Date	RLD	Marketing Status	TE Code
(NDA) 218550	001	ROZLYTREK	ENTRECTINIB	PELLETS;ORAL	50MG/PACKET	GENENTECH INC	2023-10-20	Yes	RX
(ANDA) 218149	001	METHIMAZOLE	METHIMAZOLE	TABLET;ORAL	5MG	BIONPHARMA	2023-09-25	No	RX	AB
(ANDA) 218149	002	METHIMAZOLE	METHIMAZOLE	TABLET;ORAL	10MG	BIONPHARMA	2023-09-25	No	RX	AB
(ANDA) 218122	001	LOPERAMIDE HYDROCHLORIDE	LOPERAMIDE HYDROCHLORIDE	CAPSULE;ORAL	2MG	AUROBINDO PHARMA LTD	2023-09-05	No	RX	AB
(ANDA) 218055	001	FLUPHENAZINE HYDROCHLORIDE	FLUPHENAZINE HYDROCHLORIDE	TABLET;ORAL	1MG	AUROBINDO PHARMA LTD	2023-08-18	No	RX	AB
(ANDA) 218055	002	FLUPHENAZINE HYDROCHLORIDE	FLUPHENAZINE HYDROCHLORIDE	TABLET;ORAL	2.5MG	AUROBINDO PHARMA LTD	2023-08-18	No	RX	AB
(ANDA) 218055	003	FLUPHENAZINE HYDROCHLORIDE	FLUPHENAZINE HYDROCHLORIDE	TABLET;ORAL	5MG	AUROBINDO PHARMA LTD	2023-08-18	No	RX	AB
(ANDA) 218055	004	FLUPHENAZINE HYDROCHLORIDE	FLUPHENAZINE HYDROCHLORIDE	TABLET;ORAL	10MG	AUROBINDO PHARMA LTD	2023-08-18	No	RX	AB
(ANDA) 218036	001	LITHIUM CITRATE	LITHIUM CITRATE	SYRUP;ORAL	EQ 300MG CARBONATE/5ML	RUBICON	2023-08-14	No	RX	AA
(ANDA) 218024	001	SUNITINIB MALATE	SUNITINIB MALATE	CAPSULE;ORAL	EQ 12.5MG BASE	NATCO PHARMA	2023-10-24	No	RX	AB
(ANDA) 218024	002	SUNITINIB MALATE	SUNITINIB MALATE	CAPSULE;ORAL	EQ 25MG BASE	NATCO PHARMA	2023-10-24	No	RX	AB
(ANDA) 218024	003	SUNITINIB MALATE	SUNITINIB MALATE	CAPSULE;ORAL	EQ 37.5MG BASE	NATCO PHARMA	2023-10-24	No	RX	AB
(ANDA) 218024	004	SUNITINIB MALATE	SUNITINIB MALATE	CAPSULE;ORAL	EQ 50MG BASE	NATCO PHARMA	2023-10-24	No	RX	AB
(ANDA) 218015	001	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM	TABLET;ORAL	12.5MG;50MG	GRANULES	2023-09-29	No	RX	AB
(ANDA) 218015	002	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM	TABLET;ORAL	12.5MG;100MG	GRANULES	2023-09-29	No	RX	AB
(ANDA) 218015	003	LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM	TABLET;ORAL	25MG;100MG	GRANULES	2023-09-29	No	RX	AB
(ANDA) 218012	001	SUNITINIB MALATE	SUNITINIB MALATE	CAPSULE;ORAL	EQ 12.5MG BASE	NOVUGEN	2023-08-21	No	RX	AB
(ANDA) 218012	002	SUNITINIB MALATE	SUNITINIB MALATE	CAPSULE;ORAL	EQ 25MG BASE	NOVUGEN	2023-08-21	No	RX	AB
(ANDA) 218012	003	SUNITINIB MALATE	SUNITINIB MALATE	CAPSULE;ORAL	EQ 37.5MG BASE	NOVUGEN	2023-08-21	No	RX	AB
(ANDA) 218012	004	SUNITINIB MALATE	SUNITINIB MALATE	CAPSULE;ORAL	EQ 50MG BASE	NOVUGEN	2023-08-21	No	RX	AB