Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 207769
Company: ZYDUS PHARMS

Products on ANDA 207769

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 207769

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/24/2018	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/01/2024	SUPPL-3	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 207769

DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE

CAPSULE;ORAL; 0.5MG;0.4MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE;ORAL	Prescription	No	AB	202509	ANCHEN PHARMS
DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE;ORAL	Prescription	No	AB	207769	ZYDUS PHARMS
JALYN	DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE;ORAL	Prescription	Yes	AB	022460	WOODWARD