Application 204889

Type: ANDA
Sponsor: MACLEODS PHARMS LTD

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
33342-194	Venlafaxine hydrochloride	Venlafaxine hydrochloride	Macleods Pharmaceuticals Limited	ANDA	Current
33342-194	Venlafaxine hydrochloride	Venlafaxine hydrochloride	Macleods Pharmaceuticals Limited	ANDA	Current
33342-194	Venlafaxine hydrochloride	Venlafaxine hydrochloride	Macleods Pharmaceuticals Limited	ANDA	Current
33342-194	Venlafaxine hydrochloride	Venlafaxine hydrochloride	Macleods Pharmaceuticals Limited	ANDA	Current
33342-195	Venlafaxine hydrochloride	Venlafaxine hydrochloride	Macleods Pharmaceuticals Limited	ANDA	Current
33342-195	Venlafaxine hydrochloride	Venlafaxine hydrochloride	Macleods Pharmaceuticals Limited	ANDA	Current
33342-195	Venlafaxine hydrochloride	Venlafaxine hydrochloride	Macleods Pharmaceuticals Limited	ANDA	Current
33342-195	Venlafaxine hydrochloride	Venlafaxine hydrochloride	Macleods Pharmaceuticals Limited	ANDA	Current
33342-196	Venlafaxine hydrochloride	Venlafaxine hydrochloride	Macleods Pharmaceuticals Limited	ANDA	Current
33342-196	Venlafaxine hydrochloride	Venlafaxine hydrochloride	Macleods Pharmaceuticals Limited	ANDA	Current
33342-196	Venlafaxine hydrochloride	Venlafaxine hydrochloride	Macleods Pharmaceuticals Limited	ANDA	Current
33342-196	Venlafaxine hydrochloride	Venlafaxine hydrochloride	Macleods Pharmaceuticals Limited	ANDA	Current
50090-5725	Venlafaxine hydrochloride	Venlafaxine hydrochloride	A-S Medication Solutions	ANDA	Current
50090-5731	Venlafaxine hydrochloride	Venlafaxine hydrochloride	A-S Medication Solutions	ANDA	Current
50090-5732	Venlafaxine hydrochloride	Venlafaxine hydrochloride	A-S Medication Solutions	ANDA	Current
50090-5748	Venlafaxine hydrochloride	Venlafaxine hydrochloride	A-S Medication Solutions	ANDA	Current
68071-5064	Venlafaxine hydrochloride	Venlafaxine hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5064	Venlafaxine hydrochloride	Venlafaxine hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
50014	ORIG	2017-10-11