Application 209905

Type: NDA
Sponsor: ARBOR PHARMS LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	EVEKEO ODT	AMPHETAMINE SULFATE	TABLET, ORALLY DISINTEGRATING;ORAL	5MG	Yes	No
002	EVEKEO ODT	AMPHETAMINE SULFATE	TABLET, ORALLY DISINTEGRATING;ORAL	10MG	Yes	No
003	EVEKEO ODT	AMPHETAMINE SULFATE	TABLET, ORALLY DISINTEGRATING;ORAL	15MG	Yes	No
004	EVEKEO ODT	AMPHETAMINE SULFATE	TABLET, ORALLY DISINTEGRATING;ORAL	20MG	Yes	No
005	EVEKEO ODT	AMPHETAMINE SULFATE	TABLET, ORALLY DISINTEGRATING;ORAL	2.5MG	Yes	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
24338-031	Evekeo ODT	AMPHETAMINE SULFATE	Arbor Pharmaceuticals	NDA	Current
24338-031	Evekeo ODT	AMPHETAMINE SULFATE	Azurity Pharmaceuticals, Inc.	NDA	Current
24338-031	Evekeo ODT	AMPHETAMINE SULFATE	Arbor Pharmaceuticals	NDA	Current
24338-031	Evekeo ODT	AMPHETAMINE SULFATE	Azurity Pharmaceuticals, Inc.	NDA	Current
24338-031	Evekeo ODT	AMPHETAMINE SULFATE	Arbor Pharmaceuticals	NDA	Current
24338-031	Evekeo ODT	AMPHETAMINE SULFATE	Arbor Pharmaceuticals	NDA	Current
24338-033	Evekeo ODT	AMPHETAMINE SULFATE	Arbor Pharmaceuticals	NDA	Current
24338-033	Evekeo ODT	AMPHETAMINE SULFATE	Arbor Pharmaceuticals	NDA	Current
24338-033	Evekeo ODT	AMPHETAMINE SULFATE	Azurity Pharmaceuticals, Inc.	NDA	Current
24338-033	Evekeo ODT	AMPHETAMINE SULFATE	Arbor Pharmaceuticals	NDA	Current
24338-033	Evekeo ODT	AMPHETAMINE SULFATE	Azurity Pharmaceuticals, Inc.	NDA	Current
24338-033	Evekeo ODT	AMPHETAMINE SULFATE	Arbor Pharmaceuticals	NDA	Current
24338-035	Evekeo ODT	AMPHETAMINE SULFATE	Arbor Pharmaceuticals	NDA	Current
24338-035	Evekeo ODT	AMPHETAMINE SULFATE	Arbor Pharmaceuticals	NDA	Current
24338-035	Evekeo ODT	AMPHETAMINE SULFATE	Azurity Pharmaceuticals, Inc.	NDA	Current
24338-035	Evekeo ODT	AMPHETAMINE SULFATE	Arbor Pharmaceuticals	NDA	Current
24338-035	Evekeo ODT	AMPHETAMINE SULFATE	Azurity Pharmaceuticals, Inc.	NDA	Current
24338-035	Evekeo ODT	AMPHETAMINE SULFATE	Arbor Pharmaceuticals	NDA	Current
24338-037	Evekeo ODT	AMPHETAMINE SULFATE	Arbor Pharmaceuticals	NDA	Current
24338-037	Evekeo ODT	AMPHETAMINE SULFATE	Arbor Pharmaceuticals	NDA	Current
24338-037	Evekeo ODT	AMPHETAMINE SULFATE	Azurity Pharmaceuticals, Inc.	NDA	Current
24338-037	Evekeo ODT	AMPHETAMINE SULFATE	Arbor Pharmaceuticals	NDA	Current
24338-037	Evekeo ODT	AMPHETAMINE SULFATE	Azurity Pharmaceuticals, Inc.	NDA	Current
24338-037	Evekeo ODT	AMPHETAMINE SULFATE	Arbor Pharmaceuticals	NDA	Current
24338-045	Evekeo ODT	AMPHETAMINE SULFATE	Arbor Pharmaceuticals	NDA	Current
24338-045	Evekeo ODT	AMPHETAMINE SULFATE	Arbor Pharmaceuticals	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
75796	SUPPL	2023-10-17
75795	SUPPL	2023-10-17
75766	SUPPL	2023-10-16
72227	SUPPL	2022-10-03
72226	SUPPL	2022-10-03
72210	SUPPL	2022-10-03
70331	SUPPL	2022-03-01
70330	SUPPL	2022-03-01
70292	SUPPL	2022-02-28
67115	SUPPL	2021-04-19
67099	SUPPL	2021-04-19
59284	ORIG	2019-07-09
57545	ORIG	2019-02-13
57390	ORIG	2019-01-31
57389	ORIG	2019-01-31

Application 209905

Related Records#

Application Products#

NDC Listings For This Application#

Documents#