Application 022104

Type: NDA
Sponsor: OSMOTICA PHARM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	EQ 37.5MG BASE	Yes	No
002	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	EQ 75MG BASE	Yes	No
003	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	EQ 150MG BASE	Yes	Yes
004	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	EQ 225MG BASE	Yes	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
13811-712	Venlafaxine Hydrochloride	venlafaxine hydrochloride	Trigen Laboratories, LLC	NDA AUTHORIZED GENERIC	Current
13811-712	Venlafaxine Hydrochloride	venlafaxine hydrochloride	Trigen Laboratories, LLC	NDA AUTHORIZED GENERIC	Current
13811-712	Venlafaxine Hydrochloride	venlafaxine hydrochloride	Trigen Laboratories, LLC	NDA AUTHORIZED GENERIC	Current
13811-713	Venlafaxine Hydrochloride	venlafaxine hydrochloride	Trigen Laboratories, LLC	NDA AUTHORIZED GENERIC	Current
13811-713	Venlafaxine Hydrochloride	venlafaxine hydrochloride	Trigen Laboratories, LLC	NDA AUTHORIZED GENERIC	Current
13811-713	Venlafaxine Hydrochloride	venlafaxine hydrochloride	Trigen Laboratories, LLC	NDA AUTHORIZED GENERIC	Current
13811-714	Venlafaxine Hydrochloride	venlafaxine hydrochloride	Trigen Laboratories, LLC	NDA AUTHORIZED GENERIC	Current
13811-714	Venlafaxine Hydrochloride	venlafaxine hydrochloride	Trigen Laboratories, LLC	NDA AUTHORIZED GENERIC	Current
13811-714	Venlafaxine Hydrochloride	venlafaxine hydrochloride	Trigen Laboratories, LLC	NDA AUTHORIZED GENERIC	Current
13811-715	Venlafaxine Hydrochloride	venlafaxine hydrochloride	Trigen Laboratories, LLC	NDA AUTHORIZED GENERIC	Current
13811-715	Venlafaxine Hydrochloride	venlafaxine hydrochloride	Trigen Laboratories, LLC	NDA AUTHORIZED GENERIC	Current
13811-715	Venlafaxine Hydrochloride	venlafaxine hydrochloride	Trigen Laboratories, LLC	NDA AUTHORIZED GENERIC	Current
68025-079	Venlafaxine Hydrochloride	venlafaxine hydrochloride	Vertical Pharmaceuticals, LLC	NDA AUTHORIZED GENERIC	Current
68025-079	Venlafaxine Hydrochloride	venlafaxine hydrochloride	Vertical Pharmaceuticals, LLC	NDA AUTHORIZED GENERIC	Current
68025-079	Venlafaxine Hydrochloride	venlafaxine hydrochloride	Vertical Pharmaceuticals, LLC	NDA AUTHORIZED GENERIC	Current
68025-079	Venlafaxine Hydrochloride	venlafaxine hydrochloride	Vertical Pharmaceuticals, LLC	NDA AUTHORIZED GENERIC	Current
68025-080	Venlafaxine Hydrochloride	venlafaxine hydrochloride	Vertical Pharmaceuticals, LLC	NDA AUTHORIZED GENERIC	Current
68025-080	Venlafaxine Hydrochloride	venlafaxine hydrochloride	Vertical Pharmaceuticals, LLC	NDA AUTHORIZED GENERIC	Current
68025-080	Venlafaxine Hydrochloride	venlafaxine hydrochloride	Vertical Pharmaceuticals, LLC	NDA AUTHORIZED GENERIC	Current
68025-080	Venlafaxine Hydrochloride	venlafaxine hydrochloride	Vertical Pharmaceuticals, LLC	NDA AUTHORIZED GENERIC	Current
68025-081	Venlafaxine Hydrochloride	venlafaxine hydrochloride	Vertical Pharmaceuticals, LLC	NDA AUTHORIZED GENERIC	Current
68025-081	Venlafaxine Hydrochloride	venlafaxine hydrochloride	Vertical Pharmaceuticals, LLC	NDA AUTHORIZED GENERIC	Current
68025-081	Venlafaxine Hydrochloride	venlafaxine hydrochloride	Vertical Pharmaceuticals, LLC	NDA AUTHORIZED GENERIC	Current
68025-081	Venlafaxine Hydrochloride	venlafaxine hydrochloride	Vertical Pharmaceuticals, LLC	NDA AUTHORIZED GENERIC	Current
68025-082	Venlafaxine Hydrochloride	venlafaxine hydrochloride	Vertical Pharmaceuticals, LLC	NDA AUTHORIZED GENERIC	Current
68025-082	Venlafaxine Hydrochloride	venlafaxine hydrochloride	Vertical Pharmaceuticals, LLC	NDA AUTHORIZED GENERIC	Current
68025-082	Venlafaxine Hydrochloride	venlafaxine hydrochloride	Vertical Pharmaceuticals, LLC	NDA AUTHORIZED GENERIC	Current
68025-082	Venlafaxine Hydrochloride	venlafaxine hydrochloride	Vertical Pharmaceuticals, LLC	NDA AUTHORIZED GENERIC	Current
70518-2587	Venlafaxine Hydrochloride	venlafaxine hydrochloride	REMEDYREPACK INC.	NDA AUTHORIZED GENERIC	Current
70518-2587	Venlafaxine Hydrochloride	venlafaxine hydrochloride	REMEDYREPACK INC.	NDA AUTHORIZED GENERIC	Current
70518-2587	Venlafaxine Hydrochloride	venlafaxine hydrochloride	REMEDYREPACK INC.	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
75232	SUPPL	2023-08-22
75204	SUPPL	2023-08-22
75203	SUPPL	2023-08-22
68827	SUPPL	2021-09-30
68826	SUPPL	2021-09-30
68737	SUPPL	2021-09-23
50898	SUPPL	2017-12-27
50803	SUPPL	2017-12-21
50802	SUPPL	2017-12-21
46761	SUPPL	2017-01-10
46713	SUPPL	2017-01-06
38245	SUPPL	2014-07-30
29249	SUPPL	2014-07-23
29248	SUPPL	2012-12-13
16939	SUPPL	2012-12-13
6887	SUPPL	2012-08-02
16938	SUPPL	2012-05-07
29247	SUPPL	2012-05-04
21937	ORIG	2009-07-29
16936	SUPPL	2009-04-03
29246	SUPPL	2009-03-05
16937	SUPPL	2009-02-04
6886	SUPPL	2009-02-03
44679	ORIG	2008-07-17
44171	ORIG	2008-05-30
6885	ORIG	2008-05-21

Application 022104

Related Records#

Application Products#

NDC Listings For This Application#

Documents#