Application 202880

Type: NDA
Sponsor: PERSION

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ZOHYDRO ER	HYDROCODONE BITARTRATE	CAPSULE, EXTENDED RELEASE;ORAL	10MG	Yes	Yes
002	ZOHYDRO ER	HYDROCODONE BITARTRATE	CAPSULE, EXTENDED RELEASE;ORAL	15MG	Yes	No
003	ZOHYDRO ER	HYDROCODONE BITARTRATE	CAPSULE, EXTENDED RELEASE;ORAL	20MG	Yes	No
004	ZOHYDRO ER	HYDROCODONE BITARTRATE	CAPSULE, EXTENDED RELEASE;ORAL	30MG	Yes	No
005	ZOHYDRO ER	HYDROCODONE BITARTRATE	CAPSULE, EXTENDED RELEASE;ORAL	40MG	Yes	No
006	ZOHYDRO ER	HYDROCODONE BITARTRATE	CAPSULE, EXTENDED RELEASE;ORAL	50MG	Yes	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
43376-210	Zohydro	hydrocodone bitartrate	Zogenix, Inc.	NDA	Current
43376-215	Zohydro	hydrocodone bitartrate	Zogenix, Inc.	NDA	Current
43376-220	Zohydro	hydrocodone bitartrate	Zogenix, Inc.	NDA	Current
43376-230	Zohydro	hydrocodone bitartrate	Zogenix, Inc.	NDA	Current
43376-240	Zohydro	hydrocodone bitartrate	Zogenix, Inc.	NDA	Current
43376-250	Zohydro	hydrocodone bitartrate	Zogenix, Inc.	NDA	Current
43376-310	Zohydro	hydrocodone bitartrate	Zogenix, Inc.	NDA	Current
43376-315	Zohydro	hydrocodone bitartrate	Zogenix, Inc.	NDA	Current
43376-320	Zohydro	hydrocodone bitartrate	Zogenix, Inc.	NDA	Current
43376-330	Zohydro	hydrocodone bitartrate	Zogenix, Inc.	NDA	Current
43376-340	Zohydro	hydrocodone bitartrate	Zogenix, Inc.	NDA	Current
43376-350	Zohydro	hydrocodone bitartrate	Zogenix, Inc.	NDA	Current
65224-310	ZOHYDRO ER	Hydrocodone Bitartrate	Pernix Therapeutics	NDA	Current
65224-310	ZOHYDRO ER	Hydrocodone Bitartrate	Persion Pharmaceuticals LLC	NDA	Current
65224-310	ZOHYDRO ER	Hydrocodone Bitartrate	Persion Pharmaceuticals LLC	NDA	Current
65224-310	ZOHYDRO ER	Hydrocodone Bitartrate	Persion Pharmaceuticals LLC	NDA	Current
65224-310	ZOHYDRO ER	Hydrocodone Bitartrate	Persion Pharmaceuticals LLC	NDA	Current
65224-315	ZOHYDRO ER	Hydrocodone Bitartrate	Persion Pharmaceuticals LLC	NDA	Current
65224-315	ZOHYDRO ER	Hydrocodone Bitartrate	Pernix Therapeutics	NDA	Current
65224-315	ZOHYDRO ER	Hydrocodone Bitartrate	Persion Pharmaceuticals LLC	NDA	Current
65224-315	ZOHYDRO ER	Hydrocodone Bitartrate	Persion Pharmaceuticals LLC	NDA	Current
65224-315	ZOHYDRO ER	Hydrocodone Bitartrate	Persion Pharmaceuticals LLC	NDA	Current
65224-320	ZOHYDRO ER	Hydrocodone Bitartrate	Persion Pharmaceuticals LLC	NDA	Current
65224-320	ZOHYDRO ER	Hydrocodone Bitartrate	Persion Pharmaceuticals LLC	NDA	Current
65224-320	ZOHYDRO ER	Hydrocodone Bitartrate	Persion Pharmaceuticals LLC	NDA	Current
65224-320	ZOHYDRO ER	Hydrocodone Bitartrate	Persion Pharmaceuticals LLC	NDA	Current
65224-320	ZOHYDRO ER	Hydrocodone Bitartrate	Pernix Therapeutics	NDA	Current
65224-330	ZOHYDRO ER	Hydrocodone Bitartrate	Persion Pharmaceuticals LLC	NDA	Current
65224-330	ZOHYDRO ER	Hydrocodone Bitartrate	Pernix Therapeutics	NDA	Current
65224-330	ZOHYDRO ER	Hydrocodone Bitartrate	Persion Pharmaceuticals LLC	NDA	Current
65224-330	ZOHYDRO ER	Hydrocodone Bitartrate	Persion Pharmaceuticals LLC	NDA	Current
65224-330	ZOHYDRO ER	Hydrocodone Bitartrate	Persion Pharmaceuticals LLC	NDA	Current
65224-340	ZOHYDRO ER	Hydrocodone Bitartrate	Persion Pharmaceuticals LLC	NDA	Current
65224-340	ZOHYDRO ER	Hydrocodone Bitartrate	Persion Pharmaceuticals LLC	NDA	Current
65224-340	ZOHYDRO ER	Hydrocodone Bitartrate	Persion Pharmaceuticals LLC	NDA	Current
65224-340	ZOHYDRO ER	Hydrocodone Bitartrate	Pernix Therapeutics	NDA	Current
65224-340	ZOHYDRO ER	Hydrocodone Bitartrate	Persion Pharmaceuticals LLC	NDA	Current
65224-350	ZOHYDRO ER	Hydrocodone Bitartrate	Persion Pharmaceuticals LLC	NDA	Current
65224-350	ZOHYDRO ER	Hydrocodone Bitartrate	Pernix Therapeutics	NDA	Current
65224-350	ZOHYDRO ER	Hydrocodone Bitartrate	Persion Pharmaceuticals LLC	NDA	Current
65224-350	ZOHYDRO ER	Hydrocodone Bitartrate	Persion Pharmaceuticals LLC	NDA	Current
65224-350	ZOHYDRO ER	Hydrocodone Bitartrate	Persion Pharmaceuticals LLC	NDA	Current
65224-910	Hydrocodone Bitartrate	Hydrocodone Bitartrate	Persion Pharmaceuticals LLC	NDA AUTHORIZED GENERIC	Current
65224-915	Hydrocodone Bitartrate	Hydrocodone Bitartrate	Persion Pharmaceuticals LLC	NDA AUTHORIZED GENERIC	Current
65224-920	Hydrocodone Bitartrate	Hydrocodone Bitartrate	Persion Pharmaceuticals LLC	NDA AUTHORIZED GENERIC	Current
65224-930	Hydrocodone Bitartrate	Hydrocodone Bitartrate	Persion Pharmaceuticals LLC	NDA AUTHORIZED GENERIC	Current
65224-940	Hydrocodone Bitartrate	Hydrocodone Bitartrate	Persion Pharmaceuticals LLC	NDA AUTHORIZED GENERIC	Current
65224-950	Hydrocodone Bitartrate	Hydrocodone Bitartrate	Persion Pharmaceuticals LLC	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
66647	SUPPL	2021-03-08
66646	SUPPL	2021-03-08
66578	SUPPL	2021-03-08
60419	SUPPL	2019-10-09
60418	SUPPL	2019-10-09
60377	SUPPL	2019-10-08
55722	SUPPL	2018-10-01
55721	SUPPL	2018-10-01
55559	SUPPL	2018-09-21
55558	SUPPL	2018-09-21
48585	SUPPL	2017-05-31
46442	SUPPL	2016-12-21
46441	SUPPL	2016-12-21
46321	SUPPL	2016-12-20
46320	SUPPL	2016-12-20
45449	SUPPL	2016-10-03
10127	SUPPL	2016-04-22
32331	SUPPL	2015-07-07
40232	SUPPL	2015-02-17
44871	SUPPL	2015-02-06
32330	SUPPL	2015-02-05
32329	SUPPL	2014-08-20
19395	SUPPL	2014-08-20
43417	ORIG	2014-04-14
24108	ORIG	2014-04-01
44870	ORIG	2013-11-15
19394	ORIG	2013-10-25
10126	ORIG	2013-10-25