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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) 215654	001	DEXAMETHASONE SODIUM PHOSPHATE	DEXAMETHASONE SODIUM PHOSPHATE	INJECTABLE;INJECTION	EQ 4MG PHOSPHATE/ML	GLAND PHARMA LTD	2021-08-04	No	RX	AP
(ANDA) 215506	001	PYRIMETHAMINE	PYRIMETHAMINE	TABLET;ORAL	25MG	TEVA PHARMS	2021-08-13	No	RX	AB
(NDA) 215498	001	BYLVAYP	ODEVIXIBAT	CAPSULE, PELLETS;ORAL	0.2MG	ALBIREO	2021-07-20	Yes	RX
(NDA) 215498	002	BYLVAYP	ODEVIXIBAT	CAPSULE;ORAL	0.4MG	ALBIREO	2021-07-20	Yes	RX
(NDA) 215498	003	BYLVAYP	ODEVIXIBAT	CAPSULE, PELLETS;ORAL	0.6MG	ALBIREO	2021-07-20	Yes	RX
(NDA) 215498	004	BYLVAYP	ODEVIXIBAT	CAPSULE;ORAL	1.2MG	ALBIREO	2021-07-20	Yes	RX
(ANDA) 215486	001	ACETAMINOPHEN	ACETAMINOPHEN	TABLET, EXTENDED RELEASE;ORAL	650MG	MARKSANS PHARMA	2021-08-25	No	OTC
(ANDA) 215414	001	TOPIRAMATE	TOPIRAMATE	TABLET;ORAL	25MG	ASCENT PHARMS INC	2021-08-26	No	RX	AB
(ANDA) 215414	002	TOPIRAMATE	TOPIRAMATE	TABLET;ORAL	50MG	ASCENT PHARMS INC	2021-08-26	No	RX	AB
(ANDA) 215414	003	TOPIRAMATE	TOPIRAMATE	TABLET;ORAL	100MG	ASCENT PHARMS INC	2021-08-26	No	RX	AB
(ANDA) 215414	004	TOPIRAMATE	TOPIRAMATE	TABLET;ORAL	200MG	ASCENT PHARMS INC	2021-08-26	No	RX	AB
(ANDA) 215409	001	PENICILLAMINE	PENICILLAMINE	CAPSULE;ORAL	250MG	AGGREGA	2021-08-23	No	RX	AB
(NDA) 215383	001	WELIREG	BELZUTIFAN	TABLET;ORAL	40MG	MERCK SHARP DOHME	2021-08-13	Yes	RX
(NDA) 215341	001	KERENDIAP	FINERENONE	TABLET;ORAL	10MG	BAYER HLTHCARE	2021-07-09	Yes	RX
(NDA) 215341	002	KERENDIAP	FINERENONE	TABLET;ORAL	20MG	BAYER HLTHCARE	2021-07-09	Yes	RX
(ANDA) 215316	001	DAPTOMYCIN	DAPTOMYCIN	POWDER;INTRAVENOUS	500MG/VIAL	QILU	2021-08-24	No	RX	AP
(NDA) 215256	001	WEGOVYP	SEMAGLUTIDE	SOLUTION;SUBCUTANEOUS	0.25MG/0.5ML (0.25MG/0.5ML)	NOVO	2021-06-04	Yes	RX
(NDA) 215256	002	WEGOVYP	SEMAGLUTIDE	SOLUTION;SUBCUTANEOUS	0.5MG/0.5ML (0.5MG/0.5ML)	NOVO	2021-06-04	Yes	RX
(NDA) 215256	003	WEGOVYP	SEMAGLUTIDE	SOLUTION;SUBCUTANEOUS	1MG/0.5ML (1MG/0.5ML)	NOVO	2021-06-04	Yes	RX
(NDA) 215256	004	WEGOVYP	SEMAGLUTIDE	SOLUTION;SUBCUTANEOUS	1.7MG/0.75ML (1.7MG/0.75ML)	NOVO	2021-06-04	Yes	RX