FDA Approved Products

Application #	Type	Sponsor	Product #	Drug Name	Form	Strength	Active Ingredient	Approval Date	Marketing Status	Reference Standard
761428	BLA	NOVO NORDISK INC	001	ALHEMO	SOLUTION; INJECTION	60MG/1.5ML (40MG/ML)	CONCIZUMAB	2025-07-31	Prescription	No
			002	ALHEMO	SOLUTION; INJECTION	150MG/1.5ML (100MG/ML)	CONCIZUMAB	2025-07-31	Prescription	No
			003	ALHEMO	SOLUTION; INJECTION	300MG/3ML (100MG/ML)	CONCIZUMAB	2025-07-31	Prescription	No
761315	BLA	NOVO NORDISK INC	001	ALHEMO	Injectable; Subcutaneous	60MG/1.5ML(40MG/ML)	CONCIZUMAB-MTCI	2024-12-20	Prescription	No
			002	ALHEMO	Injectable; Subcutaneous	150MG/1.5ML(100MG/ML)	CONCIZUMAB-MTCI	2024-12-20	Prescription	No
			003	ALHEMO	Injectable; Subcutaneous	300MG/3ML(100MG/ML)	CONCIZUMAB-MTCI	2024-12-20	Prescription	No
215842	NDA	NOVO	001	RIVFLOZA	SOLUTION;INJECTION	EQ 80MG BASE/0.5ML (EQ 160MG BASE/ML)	NEDOSIRAN SODIUM	2023-09-29	Prescription	Yes
			002	RIVFLOZA	SOLUTION;INJECTION	EQ 128MG BASE/0.8ML (EQ 160MG BASE/ML)	NEDOSIRAN SODIUM	2023-09-29	Prescription	Yes
			003	RIVFLOZA	SOLUTION;INJECTION	EQ 160MG BASE/ML (EQ 160MG BASE/ML)	NEDOSIRAN SODIUM	2023-09-29	Prescription	Yes
215256	NDA	NOVO	001	WEGOVY	SOLUTION;SUBCUTANEOUS	0.25MG/0.5ML (0.25MG/0.5ML)	SEMAGLUTIDE	2021-06-04	Prescription	Yes
			002	WEGOVY	SOLUTION;SUBCUTANEOUS	0.5MG/0.5ML (0.5MG/0.5ML)	SEMAGLUTIDE	2021-06-04	Prescription	Yes
			003	WEGOVY	SOLUTION;SUBCUTANEOUS	1MG/0.5ML (1MG/0.5ML)	SEMAGLUTIDE	2021-06-04	Prescription	Yes
			004	WEGOVY	SOLUTION;SUBCUTANEOUS	1.7MG/0.75ML (1.7MG/0.75ML)	SEMAGLUTIDE	2021-06-04	Prescription	Yes
			005	WEGOVY	SOLUTION;SUBCUTANEOUS	2.4MG/0.75ML (2.4MG/0.75ML)	SEMAGLUTIDE	2021-06-04	Prescription	Yes
761156	BLA	NOVO NORDISK INC	001	SOGROYA	SOLUTION;SUBCUTANEOUS	10MG/1.5ML	SOMAPACITAN-BECO	2020-08-28	Prescription	No
213182	NDA	NOVO NORDISK INC	001	RYBELSUS	TABLET;ORAL	3MG	SEMAGLUTIDE	2020-01-16	Prescription	No
213182	NDA	NOVO NORDISK INC	002	RYBELSUS	TABLET;ORAL	7MG	SEMAGLUTIDE	2020-01-16	Prescription	No
213051	NDA	NOVO	001	RYBELSUS	TABLET;ORAL	3MG	SEMAGLUTIDE	2019-09-20	Prescription	Yes
			002	RYBELSUS	TABLET;ORAL	7MG	SEMAGLUTIDE	2019-09-20	Prescription	Yes
			003	RYBELSUS	TABLET;ORAL	14MG	SEMAGLUTIDE	2019-09-20	Prescription	Yes
			004	RYBELSUS	TABLET;ORAL	1.5MG	SEMAGLUTIDE	2019-09-20	Prescription	No
			005	RYBELSUS	TABLET;ORAL	4MG	SEMAGLUTIDE	2019-09-20	Prescription	No
			006	RYBELSUS	TABLET;ORAL	9MG	SEMAGLUTIDE	2019-09-20	Prescription	Yes
205598	NDA	NOVO	001	MACRILEN	FOR SOLUTION;ORAL	EQ 60MG BASE/POUCH	MACIMORELIN ACETATE	2017-12-20	Discontinued	No
209637	NDA	NOVO	001	OZEMPIC	SOLUTION;SUBCUTANEOUS	2MG/1.5ML (1.34MG/ML)	SEMAGLUTIDE	2017-12-05	Prescription	Yes
			002	OZEMPIC	SOLUTION;SUBCUTANEOUS	4MG/3ML (1.34MG/ML)	SEMAGLUTIDE	2017-12-05	Prescription	Yes
			003	OZEMPIC	SOLUTION;SUBCUTANEOUS	8MG/3ML (2.68MG/ML)	SEMAGLUTIDE	2017-12-05	Prescription	Yes
			004	OZEMPIC	SOLUTION;SUBCUTANEOUS	2MG/3ML (0.68MG/ML)	SEMAGLUTIDE	2017-12-05	Prescription	Yes
208751	BLA	NOVO	001	FIASP	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	1000 UNITS/10ML (100 UNITS/ML)	INSULIN ASPART	2017-09-29	Prescription	No
			002	FIASP FLEXTOUCH	SOLUTION;SUBCUTANEOUS	300 UNITS/3ML (100 UNITS/ML)	INSULIN ASPART	2017-09-29	Prescription	No
			003	FIASP PENFILL	SOLUTION;SUBCUTANEOUS	300 UNITS/3ML (100 UNITS/ML)	INSULIN ASPART	2017-09-29	Prescription	No
208583	BLA	NOVO	001	XULTOPHY 100/3.6	SOLUTION;SUBCUTANEOUS	300 UNITS/3ML;10.8MG/3ML (100 UNITS/ML;3.6MG/ML)	INSULIN DEGLUDEC; LIRAGLUTIDE	2016-11-21	Prescription	No
203313	BLA	NOVO	001	RYZODEG 70/30	SOLUTION;SUBCUTANEOUS	90 UNITS/3ML;210 UNITS/3ML (30 UNITS/ML;70 UNITS/ML)	INSULIN ASPART; INSULIN DEGLUDEC	2015-09-25	Discontinued	No
203314	BLA	NOVO	001	TRESIBA	SOLUTION;SUBCUTANEOUS	300 UNITS/3ML (100 UNITS/ML)	INSULIN DEGLUDEC	2015-09-25	Prescription	No
			002	TRESIBA	SOLUTION;SUBCUTANEOUS	600 UNITS/3ML (200 UNITS/ML)	INSULIN DEGLUDEC	2015-09-25	Prescription	No
			003	TRESIBA	SOLUTION;SUBCUTANEOUS	1000 UNITS/10ML (100 UNITS/ML)	INSULIN DEGLUDEC	2015-09-25	Prescription	No
206321	NDA	NOVO	001	SAXENDA	SOLUTION;SUBCUTANEOUS	18MG/3ML (6MG/ML)	LIRAGLUTIDE	2014-12-23	Prescription	Yes
022341	NDA	NOVO NORDISK INC	001	VICTOZA	SOLUTION;SUBCUTANEOUS	18MG/3ML (6MG/ML)	LIRAGLUTIDE	2010-01-25	Prescription	Yes
021810	BLA	NOVO NORDISK INC	001	NOVOLOG MIX 50/50	INJECTABLE;SUBCUTANEOUS	50 UNITS/ML;50 UNITS/ML	INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT	2008-08-26	Discontinued	No
022386	NDA	NOVO NORDISK INC	001	PRANDIMET	TABLET;ORAL	500MG;1MG	METFORMIN HYDROCHLORIDE; REPAGLINIDE	2008-06-23	Discontinued	No
022386	NDA	NOVO NORDISK INC	002	PRANDIMET	TABLET;ORAL	500MG;2MG	METFORMIN HYDROCHLORIDE; REPAGLINIDE	2008-06-23	Discontinued	No
022001	NDA	NOVO NORDISK INC	001	ACTIVELLA	TABLET; ORAL	1MG/0.5MG	ESTRADIOL; NORETHINDRONE ACETATE	2006-12-29	Prescription	No
021878	BLA	NOVO NORDISK	001	LEVEMIR	INJECTABLE; INJECTION	100 UNITS/ML	INSULIN DETEMIR	2005-10-19	Prescription	No
021536	BLA	NOVO NORDISK INC	001	LEVEMIR	INJECTABLE;SUBCUTANEOUS	1000 UNITS/10ML (100 UNITS/ML)	INSULIN DETEMIR RECOMBINANT	2005-06-16	Prescription	No
			002	LEVEMIR FLEXPEN	INJECTABLE;SUBCUTANEOUS	300 UNITS/3ML (100 UNITS/ML)	INSULIN DETEMIR RECOMBINANT	2005-06-16	Discontinued	No
			005	LEVEMIR FLEXTOUCH	INJECTABLE;SUBCUTANEOUS	300 UNITS/3ML (100 UNITS/ML)	INSULIN DETEMIR RECOMBINANT	2005-06-16	Prescription	No
			003	LEVEMIR INNOLET	INJECTABLE;SUBCUTANEOUS	300 UNITS/3ML (100 UNITS/ML)	INSULIN DETEMIR RECOMBINANT	2005-06-16	Discontinued	No
			004	LEVEMIR PENFILL	INJECTABLE;SUBCUTANEOUS	300 UNITS/3ML (100 UNITS/ML)	INSULIN DETEMIR RECOMBINANT	2005-06-16	Discontinued	No
021172	BLA	NOVO NORDISK INC	001	NOVOLOG MIX 70/30	INJECTABLE;SUBCUTANEOUS	700 UNITS/10ML; 300 UNITS/10ML (70 UNITS/ML; 30 UNITS/ML)	INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT	2001-11-01	Prescription	No
			004	NOVOLOG MIX 70/30 FLEXPEN	INJECTABLE;SUBCUTANEOUS	210 UNITS/3ML; 90 UNITS/3ML (70 UNITS/ML; 30 UNITS/ML)	INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT	2001-11-01	Prescription	No
			002	NOVOLOG MIX 70/30 PENFILL	INJECTABLE;SUBCUTANEOUS	210 UNITS/3ML;90 UNITS/3ML (70 UNITS/ML; 30 UNITS/ML)	INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT	2001-11-01	Discontinued	No
			003	NOVOLOG MIX 70/30 PENFILL	INJECTABLE;SUBCUTANEOUS	210 UNITS/3ML;90 UNITS/3ML (70 UNITS/ML; 30 UNITS/ML)	INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT	2001-11-01	Discontinued	No
021148	BLA	NOVO NORDISK INC	001	NORDITROPIN	INJECTABLE;INJECTION	5MG/1.5ML	SOMATROPIN	2000-06-20	Discontinued	No
			002	NORDITROPIN	INJECTABLE;INJECTION	10MG/1.5ML	SOMATROPIN	2000-06-20	Discontinued	No
			003	NORDITROPIN	INJECTABLE;INJECTION	15MG/1.5ML	SOMATROPIN	2000-06-20	Discontinued	No
			008	NORDITROPIN FLEXPRO	INJECTABLE;INJECTION	5MG/1.5ML	SOMATROPIN	2000-06-20	Prescription	No
			009	NORDITROPIN FLEXPRO	INJECTABLE;INJECTION	10MG/1.5ML	SOMATROPIN	2000-06-20	Prescription	No
			010	NORDITROPIN FLEXPRO	INJECTABLE;INJECTION	15MG/1.5ML	SOMATROPIN	2000-06-20	Prescription	No
			011	NORDITROPIN FLEXPRO	INJECTABLE;INJECTION	30MG/3ML	SOMATROPIN	2000-06-20	Prescription	No
			004	NORDITROPIN NORDIFLEX	INJECTABLE;INJECTION	5MG/1.5ML	SOMATROPIN	2000-06-20	Discontinued	No
			005	NORDITROPIN NORDIFLEX	INJECTABLE;INJECTION	10MG/1.5ML	SOMATROPIN	2000-06-20	Discontinued	No
			006	NORDITROPIN NORDIFLEX	INJECTABLE;INJECTION	15MG/1.5ML	SOMATROPIN	2000-06-20	Discontinued	No
			007	NORDITROPIN NORDIFLEX	INJECTABLE;INJECTION	30MG/3ML	SOMATROPIN	2000-06-20	Discontinued	No
020986	BLA	NOVO NORDISK INC	001	NOVOLOG	INJECTABLE;SUBCUTANEOUS	1000 UNITS/10ML (100 UNITS/ML)	INSULIN ASPART RECOMBINANT	2000-06-07	Prescription	No
			003	NOVOLOG FLEXPEN	INJECTABLE;SUBCUTANEOUS	300 UNITS/3ML (100 UNITS/ML)	INSULIN ASPART RECOMBINANT	2000-06-07	Prescription	No
			005	NOVOLOG FLEXTOUCH	INJECTABLE;SUBCUTANEOUS	300 UNITS/3ML (100 UNITS/ML)	INSULIN ASPART RECOMBINANT	2000-06-07	Discontinued	No
			004	NOVOLOG INNOLET	INJECTABLE;SUBCUTANEOUS	300 UNITS/3ML (100 UNITS/ML)	INSULIN ASPART RECOMBINANT	2000-06-07	Discontinued	No
			002	NOVOLOG PENFILL	INJECTABLE;SUBCUTANEOUS	300 UNITS/3ML (100 UNITS/ML)	INSULIN ASPART RECOMBINANT	2000-06-07	Prescription	No
021103	NDA	NOVO NORDISK	001	ACTIVELLA	TABLET; ORAL	1MG/0.5MG	ESTRADIOL; NORETHINDRONE ACETATE	2000-04-11	Discontinued	No
040312	ANDA	NOVO NORDISK INC	001	INNOFEM	TABLET;ORAL	0.5MG	ESTRADIOL	1999-11-19	Discontinued	No
			002	INNOFEM	TABLET;ORAL	1MG	ESTRADIOL	1999-11-19	Discontinued	No
			003	INNOFEM	TABLET;ORAL	2MG	ESTRADIOL	1999-11-19	Discontinued	No
020908	NDA	NOVO NORDISK INC	001	VAGIFEM	TABLET;VAGINAL	25MCG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	ESTRADIOL	1999-03-26	Discontinued	No
020908	NDA	NOVO NORDISK INC	002	VAGIFEM	TABLET;VAGINAL	10MCG	ESTRADIOL	1999-03-26	Prescription	Yes
020918	NDA	NOVO NORDISK	001	GLUCAGEN	POWDER;INTRAMUSCULAR, INTRAVENOUS	EQ 1MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GLUCAGON HYDROCHLORIDE	1998-06-22	Discontinued	No
020918	NDA	NOVO NORDISK	002	GLUCAGEN	POWDER;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	EQ 1MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GLUCAGON HYDROCHLORIDE	1998-06-22	Discontinued	No
019959	BLA	NOVO NORDISK INC	001	NOVOLIN N	INJECTABLE;INJECTION	100 UNITS/ML	INSULIN SUSP ISOPHANE RECOMBINANT HUMAN	1991-07-01	Over-the-counter	No
019991	BLA	NOVO NORDISK INC	001	NOVOLIN 70/30	INJECTABLE;INJECTION	30 UNITS/ML;70 UNITS/ML	INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN	1991-06-25	Over-the-counter	No
019938	BLA	NOVO NORDISK INC	001	NOVOLIN R	INJECTABLE;INJECTION	100 UNITS/ML	INSULIN RECOMBINANT HUMAN	1991-06-25	Over-the-counter	No