Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202509
Company: PH HEALTH

Products on ANDA 202509

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 202509

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/26/2014	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202509Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/26/2023	SUPPL-16	Labeling-Package Insert		Label is not available on this site.
10/23/2020	SUPPL-11	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 202509

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	213300	AUROBINDO PHARMA
DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE	DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE	0.5MG;0.4MG	CAPSULE;ORAL	Prescription	No	AB	202509	PH HEALTH
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	WAYLIS THERAP