Application 022272

Type: NDA
Sponsor: PURDUE PHARMA LP

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OXYCONTIN	OXYCODONE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	10MG	Yes	No
002	OXYCONTIN	OXYCODONE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	15MG	Yes	No
003	OXYCONTIN	OXYCODONE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	20MG	Yes	No
004	OXYCONTIN	OXYCODONE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	30MG	Yes	No
005	OXYCONTIN	OXYCODONE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	40MG	Yes	Yes
006	OXYCONTIN	OXYCODONE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	60MG	Yes	No
007	OXYCONTIN	OXYCODONE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	80MG	Yes	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0093-5731	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-5731	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-5731	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-5731	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-5731	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-5731	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-5731	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-5731	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-5732	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-5732	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-5732	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-5732	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-5732	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-5732	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-5732	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-5732	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-5733	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-5733	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-5733	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-5733	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-5733	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-5733	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-5733	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-5733	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-5734	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-5734	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-5734	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-5734	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-5734	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-5734	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-5734	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0093-5734	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Teva Pharmaceuticals USA, Inc.	NDA AUTHORIZED GENERIC	Current
0115-1556	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	Amneal Pharmaceuticals of New York LLC	NDA AUTHORIZED GENERIC	Current
0115-1556	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	Impax Generics	NDA AUTHORIZED GENERIC	Current
0115-1556	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	Amneal Pharmaceuticals of New York LLC	NDA AUTHORIZED GENERIC	Current
0115-1557	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	Amneal Pharmaceuticals of New York LLC	NDA AUTHORIZED GENERIC	Current
0115-1557	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	Impax Generics	NDA AUTHORIZED GENERIC	Current
0115-1557	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	Amneal Pharmaceuticals of New York LLC	NDA AUTHORIZED GENERIC	Current
0115-1558	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	Amneal Pharmaceuticals of New York LLC	NDA AUTHORIZED GENERIC	Current
0115-1558	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	Impax Generics	NDA AUTHORIZED GENERIC	Current
0115-1558	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	Amneal Pharmaceuticals of New York LLC	NDA AUTHORIZED GENERIC	Current
0115-1559	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	Amneal Pharmaceuticals of New York LLC	NDA AUTHORIZED GENERIC	Current
0115-1559	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	Impax Generics	NDA AUTHORIZED GENERIC	Current
0115-1559	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	Amneal Pharmaceuticals of New York LLC	NDA AUTHORIZED GENERIC	Current
0115-1560	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	Amneal Pharmaceuticals of New York LLC	NDA AUTHORIZED GENERIC	Current
0115-1560	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	Impax Generics	NDA AUTHORIZED GENERIC	Current
0115-1560	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	Amneal Pharmaceuticals of New York LLC	NDA AUTHORIZED GENERIC	Current
0115-1561	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	Amneal Pharmaceuticals of New York LLC	NDA AUTHORIZED GENERIC	Current
0115-1561	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	Impax Generics	NDA AUTHORIZED GENERIC	Current
0115-1561	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	Amneal Pharmaceuticals of New York LLC	NDA AUTHORIZED GENERIC	Current
0115-1562	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	Amneal Pharmaceuticals of New York LLC	NDA AUTHORIZED GENERIC	Current
0115-1562	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	Impax Generics	NDA AUTHORIZED GENERIC	Current
0115-1562	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	Amneal Pharmaceuticals of New York LLC	NDA AUTHORIZED GENERIC	Current
0591-2693	Oxycodone Hydrochloride	oxycodone hydrochloride	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
0591-2693	Oxycodone Hydrochloride	oxycodone hydrochloride	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
0591-2693	Oxycodone Hydrochloride	oxycodone hydrochloride	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
0591-2693	Oxycodone Hydrochloride	oxycodone hydrochloride	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
0591-2708	Oxycodone Hydrochloride	oxycodone hydrochloride	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
0591-2708	Oxycodone Hydrochloride	oxycodone hydrochloride	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
0591-2708	Oxycodone Hydrochloride	oxycodone hydrochloride	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
0591-2708	Oxycodone Hydrochloride	oxycodone hydrochloride	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
0781-5703	oxycodone hydrochloride	oxycodone hydrochloride	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-5726	oxycodone hydrochloride	oxycodone hydrochloride	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-5767	oxycodone hydrochloride	oxycodone hydrochloride	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-5785	oxycodone hydrochloride	oxycodone hydrochloride	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
10702-801	OXYCODONE HCl	OXYCODONE HCl	KVK-Tech, Inc.	NDA AUTHORIZED GENERIC	Current
10702-801	OXYCODONE HCl	OXYCODONE HCl	KVK-Tech, Inc.	NDA AUTHORIZED GENERIC	Current
10702-803	OXYCODONE HCl	OXYCODONE HCl	KVK-Tech, Inc.	NDA AUTHORIZED GENERIC	Current
10702-803	OXYCODONE HCl	OXYCODONE HCl	KVK-Tech, Inc.	NDA AUTHORIZED GENERIC	Current
10702-805	OXYCODONE HCl	OXYCODONE HCl	KVK-Tech, Inc.	NDA AUTHORIZED GENERIC	Current
10702-805	OXYCODONE HCl	OXYCODONE HCl	KVK-Tech, Inc.	NDA AUTHORIZED GENERIC	Current
21695-941	OxyContin	oxycodone hydrochloride	Rebel Distributors Corp	NDA	Current
21695-951	OxyContin	oxycodone hydrochloride	Rebel Distributors Corp	NDA	Current
31722-109	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Camber Pharmaceuticals, Inc.	NDA	Current
31722-110	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Camber Pharmaceuticals, Inc.	NDA	Current
31722-111	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Camber Pharmaceuticals, Inc.	NDA	Current
42254-159	OxyContin	oxycodone hydrochloride	Rebel Distributors Corp	NDA	Current
49884-136	oxycodone hydrochloride	oxycodone hydrochloride	Par Pharmaceutical, Inc.	NDA AUTHORIZED GENERIC	Current
49884-137	oxycodone hydrochloride	oxycodone hydrochloride	Par Pharmaceutical, Inc.	NDA AUTHORIZED GENERIC	Current
49884-138	oxycodone hydrochloride	oxycodone hydrochloride	Par Pharmaceutical, Inc.	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84662	SUPPL	2026-01-06
84610	SUPPL	2025-12-31
80074	SUPPL	2024-11-04
77031	SUPPL	2023-12-19
76930	SUPPL	2023-12-18
76929	SUPPL	2023-12-18
69175	SUPPL	2021-10-29
69174	SUPPL	2021-10-29
69151	SUPPL	2021-10-29
66607	SUPPL	2021-03-08
66606	SUPPL	2021-03-08
66558	SUPPL	2021-03-05
60857	SUPPL	2019-11-15
60848	SUPPL	2019-11-15
60442	SUPPL	2019-10-09
60381	SUPPL	2019-10-09
60380	SUPPL	2019-10-08
55775	SUPPL	2018-10-01
55774	SUPPL	2018-10-01
55758	SUPPL	2018-10-01
55700	SUPPL	2018-10-01
55699	SUPPL	2018-10-01
55630	SUPPL	2018-09-27
48567	SUPPL	2017-05-30
46341	SUPPL	2016-12-21
46299	SUPPL	2016-12-20
45466	SUPPL	2016-10-04
24023	ORIG	2015-11-04
42477	SUPPL	2015-09-29
29504	SUPPL	2015-08-13
17180	SUPPL	2015-08-13
7153	SUPPL	2015-07-06
29502	SUPPL	2014-10-30
17179	SUPPL	2014-10-30
29503	SUPPL	2014-08-20
7152	SUPPL	2014-04-17
17178	SUPPL	2014-04-16
42476	SUPPL	2013-04-26
38481	SUPPL	2013-04-16
29501	SUPPL	2013-04-16
29500	SUPPL	2013-04-16
44179	ORIG	2013-02-15
38482	SUPPL	2013-01-15
7151	SUPPL	2013-01-14
38480	SUPPL	2012-07-13
38479	SUPPL	2012-07-12
7150	SUPPL	2012-07-11
7149	SUPPL	2012-07-11
17177	SUPPL	2011-10-12
7148	SUPPL	2011-10-11
44723	ORIG	2011-02-17
38478	SUPPL	2010-11-26
7147	SUPPL	2010-11-22
21975	ORIG	2010-09-29
44493	ORIG	2010-08-06
38477	SUPPL	2010-07-01
7146	SUPPL	2010-07-01
7145	ORIG	2010-04-09
17176	ORIG	2010-04-06
51536	ORIG	1900-01-01
51535	ORIG	1900-01-01
51534	ORIG	1900-01-01