Application 209637

Type: NDA
Sponsor: NOVO

Related Records

Company: NOVO

Application Products

Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OZEMPIC	SEMAGLUTIDE	SOLUTION;SUBCUTANEOUS	2MG/1.5ML (1.34MG/ML)	Yes	Yes
002	OZEMPIC	SEMAGLUTIDE	SOLUTION;SUBCUTANEOUS	4MG/3ML (1.34MG/ML)	Yes	Yes
003	OZEMPIC	SEMAGLUTIDE	SOLUTION;SUBCUTANEOUS	8MG/3ML (2.68MG/ML)	Yes	Yes
004	OZEMPIC	SEMAGLUTIDE	SOLUTION;SUBCUTANEOUS	2MG/3ML (0.68MG/ML)	Yes	No

NDC Listings For This Application

NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0169-4130	Ozempic	semaglutide	Novo Nordisk	NDA	Current
0169-4130	Ozempic	semaglutide	Novo Nordisk	NDA	Current
0169-4130	Ozempic	semaglutide	Novo Nordisk	NDA	Current
0169-4130	Ozempic	semaglutide	Novo Nordisk	NDA	Current
0169-4130	Ozempic	semaglutide	Novo Nordisk	NDA	Current
0169-4130	Ozempic	semaglutide	Novo Nordisk	NDA	Current
0169-4130	Ozempic	semaglutide	Novo Nordisk	NDA	Current
0169-4132	Ozempic	semaglutide	Novo Nordisk	NDA	Current
0169-4132	Ozempic	semaglutide	Novo Nordisk	NDA	Current
0169-4132	Ozempic	semaglutide	Novo Nordisk	NDA	Current
0169-4132	Ozempic	semaglutide	Novo Nordisk	NDA	Current
0169-4132	Ozempic	semaglutide	Novo Nordisk	NDA	Current
0169-4132	Ozempic	semaglutide	Novo Nordisk	NDA	Current
0169-4132	Ozempic	semaglutide	Novo Nordisk	NDA	Current
0169-4132	Ozempic	semaglutide	Novo Nordisk	NDA	Current
0169-4132	Ozempic	semaglutide	Novo Nordisk	NDA	Current
0169-4132	Ozempic	semaglutide	Novo Nordisk	NDA	Current
0169-4132	Ozempic	semaglutide	Novo Nordisk	NDA	Current
0169-4136	Ozempic	semaglutide	Novo Nordisk	NDA	Current
0169-4136	Ozempic	semaglutide	Novo Nordisk	NDA	Current
0169-4136	Ozempic	semaglutide	Novo Nordisk	NDA	Current
0169-4136	Ozempic	semaglutide	Novo Nordisk	NDA	Current
0169-4136	Ozempic	semaglutide	Novo Nordisk	NDA	Current
0169-4136	Ozempic	semaglutide	Novo Nordisk	NDA	Current
0169-4136	Ozempic	semaglutide	Novo Nordisk	NDA	Current
0169-4136	Ozempic	semaglutide	Novo Nordisk	NDA	Current
0169-4136	Ozempic	semaglutide	Novo Nordisk	NDA	Current
0169-4136	Ozempic	semaglutide	Novo Nordisk	NDA	Current
0169-4136	Ozempic	semaglutide	Novo Nordisk	NDA	Current
0169-4181	Ozempic	semaglutide	Novo Nordisk	NDA	Current
0169-4772	Ozempic	semaglutide	Novo Nordisk	NDA	Current
0169-4772	Ozempic	semaglutide	Novo Nordisk	NDA	Current
0169-4772	Ozempic	semaglutide	Novo Nordisk	NDA	Current
50090-5138	Ozempic	semaglutide	A-S Medication Solutions	NDA	Current
50090-5139	Ozempic	semaglutide	A-S Medication Solutions	NDA	Current
50090-5949	Ozempic	semaglutide	A-S Medication Solutions	NDA	Current
50090-6051	OZEMPIC	semaglutide	A-S Medication Solutions	NDA	Current
50090-6051	OZEMPIC	semaglutide	A-S Medication Solutions	NDA	Current
70518-2143	Ozempic	semaglutide	REMEDYREPACK INC.	NDA	Current
70518-2143	Ozempic	semaglutide	REMEDYREPACK INC.	NDA	Current
70518-2143	Ozempic	semaglutide	REMEDYREPACK INC.	NDA	Current
70518-2143	Ozempic	semaglutide	REMEDYREPACK INC.	NDA	Current

Documents

Document	Submission type	Date
85146	SUPPL	2026-02-24
85119	SUPPL	2026-02-24
85118	SUPPL	2026-02-24
83783	SUPPL	2025-10-15
83782	SUPPL	2025-10-15
83781	SUPPL	2025-10-15
83776	SUPPL	2025-10-15
83775	SUPPL	2025-10-15
81169	SUPPL	2025-02-07
80998	SUPPL	2025-02-05
80142	SUPPL	2024-11-05
80127	SUPPL	2024-11-05
75556	SUPPL	2023-09-25
75555	SUPPL	2023-09-25
75551	SUPPL	2023-09-25
75550	SUPPL	2023-09-25
72296	SUPPL	2022-10-11
72295	SUPPL	2022-10-11
72275	SUPPL	2022-10-07
70645	SUPPL	2022-03-29
70644	SUPPL	2022-03-29
70639	SUPPL	2022-03-29
67061	SUPPL	2021-04-14
67060	SUPPL	2021-04-14
67048	SUPPL	2021-04-13
61599	SUPPL	2020-01-17
61594	SUPPL	2020-01-17
61593	SUPPL	2020-01-17
61112	SUPPL	2019-12-02
61113	SUPPL	2019-11-29
61094	SUPPL	2019-11-29
58289	SUPPL	2019-04-11
58271	SUPPL	2019-04-10
51050	ORIG	2018-01-16
50623	ORIG	2017-12-07
50622	ORIG	2017-12-06