Application 125320

Type: BLA
Sponsor: AMGEN

Related Records

Company: AMGEN

Application Products

Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PROLIA	DENOSUMAB	INJECTABLE; SUBCUTANEOUS	60MG/ML	No	No
002	XGEVA	DENOSUMAB	INJECTABLE; SUBCUTANEOUS	70MG/ML	No	No

NDC Listings For This Application

NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
55513-710	Prolia	denosumab	Amgen Inc	BLA	Current
55513-710	Prolia	denosumab	Amgen Inc	BLA	Current
55513-710	Prolia	denosumab	Amgen Inc	BLA	Current
55513-710	Prolia	denosumab	Amgen Inc	BLA	Current
55513-710	Prolia	denosumab	Amgen Inc	BLA	Current
55513-710	Prolia	denosumab	Amgen Inc	BLA	Current
55513-710	Prolia	denosumab	Amgen Inc	BLA	Current
55513-710	Prolia	denosumab	Amgen Inc	BLA	Current
55513-730	XGEVA	denosumab	Amgen Inc	BLA	Current
55513-730	XGEVA	denosumab	Amgen Inc	BLA	Current
55513-730	XGEVA	denosumab	Amgen Inc	BLA	Current
55513-730	XGEVA	denosumab	Amgen Inc	BLA	Current
55513-730	XGEVA	denosumab	Amgen Inc	BLA	Current
55513-730	XGEVA	denosumab	Amgen Inc	BLA	Current
55513-730	XGEVA	denosumab	Amgen Inc	BLA	Current

Documents

Document	Submission type	Date
82428	SUPPL	2025-06-02
82421	SUPPL	2025-06-02
82409	SUPPL	2025-06-02
82408	SUPPL	2025-06-02
82320	SUPPL	2025-05-27
82158	SUPPL	2025-05-05
82134	SUPPL	2025-05-05
78107	SUPPL	2024-04-10
77733	SUPPL	2024-03-06
77715	SUPPL	2024-03-05
77714	SUPPL	2024-03-05
77265	SUPPL	2024-01-22
77248	SUPPL	2024-01-22
73100	SUPPL	2023-01-05
73099	SUPPL	2023-01-05
73081	SUPPL	2023-01-04
71109	SUPPL	2022-05-20
71107	SUPPL	2022-05-20
71106	SUPPL	2022-05-20
67483	SUPPL	2021-05-13
67482	SUPPL	2021-05-13
67478	SUPPL	2021-05-13
63568	SUPPL	2020-06-15
63477	SUPPL	2020-06-10
62673	SUPPL	2020-04-24
62669	SUPPL	2020-04-24
62668	SUPPL	2020-04-24
61863	SUPPL	2020-02-11
61862	SUPPL	2020-02-11
60215	SUPPL	2019-10-03
60189	SUPPL	2019-10-02
60188	SUPPL	2019-10-02
59496	SUPPL	2019-07-30
59480	SUPPL	2019-07-29
58953	SUPPL	2019-06-04
58870	SUPPL	2019-05-29
58690	SUPPL	2019-05-14
58689	SUPPL	2019-05-14
58644	SUPPL	2019-05-13
58643	SUPPL	2019-05-13
58511	SUPPL	2019-05-02
58500	SUPPL	2019-05-01
57220	SUPPL	2019-01-15
57219	SUPPL	2019-01-15
56508	SUPPL	2018-11-20
54564	SUPPL	2018-06-14
54496	SUPPL	2018-06-11
43320	SUPPL	2018-06-05
54285	SUPPL	2018-05-22
54278	SUPPL	2018-05-21
51909	SUPPL	2018-01-26
51905	SUPPL	2018-01-26
51006	SUPPL	2018-01-09
50980	SUPPL	2018-01-04
48569	SUPPL	2017-05-30
48571	SUPPL	2017-05-26
47075	SUPPL	2017-01-31
45538	SUPPL	2016-10-17
45537	SUPPL	2016-10-17
45039	SUPPL	2016-08-05
45031	SUPPL	2016-08-05
45026	SUPPL	2016-08-05
45025	SUPPL	2016-08-05
45024	SUPPL	2016-08-05
45023	SUPPL	2016-08-05
45014	SUPPL	2016-08-05
45013	SUPPL	2016-08-05
45011	SUPPL	2016-08-05
45010	SUPPL	2016-08-05
45009	SUPPL	2016-08-05
45008	SUPPL	2016-08-05
45007	SUPPL	2016-08-05
31930	SUPPL	2016-03-04
18871	SUPPL	2016-03-04
31929	SUPPL	2015-06-10
18870	SUPPL	2015-06-10
9707	SUPPL	2015-05-26
9709	SUPPL	2015-04-13
39929	SUPPL	2015-04-10
39928	SUPPL	2015-03-02
9708	SUPPL	2015-03-02
39927	SUPPL	2014-12-10
9706	SUPPL	2014-12-09
9704	SUPPL	2014-06-18
39926	SUPPL	2014-06-17
9705	SUPPL	2014-06-05
18869	SUPPL	2014-06-04
39925	SUPPL	2013-08-27
39924	SUPPL	2013-08-27
9703	SUPPL	2013-08-27
9702	SUPPL	2013-08-27
31928	SUPPL	2013-07-08
39923	SUPPL	2013-07-05
39922	SUPPL	2013-06-13
31927	SUPPL	2013-06-13
31925	SUPPL	2013-02-20
18867	SUPPL	2013-02-20
18865	SUPPL	2012-09-25
31923	SUPPL	2012-09-24
31926	SUPPL	2012-09-18