Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 214768
Company: BIOCON GENERICS

Products on ANDA 214768

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TRIAMTERENE	TRIAMTERENE	50MG	CAPSULE;ORAL	Prescription	AB	No	No
TRIAMTERENE	TRIAMTERENE	100MG	CAPSULE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 214768

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/06/2022	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 214768

TRIAMTERENE

CAPSULE;ORAL; 50MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DYRENIUM	TRIAMTERENE	50MG	CAPSULE;ORAL	Prescription	Yes	AB	013174	ADVANZ PHARMA
TRIAMTERENE	TRIAMTERENE	50MG	CAPSULE;ORAL	Prescription	No	AB	211581	AGNITIO
TRIAMTERENE	TRIAMTERENE	50MG	CAPSULE;ORAL	Prescription	No	AB	214768	BIOCON GENERICS

CAPSULE;ORAL; 100MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DYRENIUM	TRIAMTERENE	100MG	CAPSULE;ORAL	Prescription	Yes	AB	013174	ADVANZ PHARMA
TRIAMTERENE	TRIAMTERENE	100MG	CAPSULE;ORAL	Prescription	No	AB	211581	AGNITIO
TRIAMTERENE	TRIAMTERENE	100MG	CAPSULE;ORAL	Prescription	No	AB	214768	BIOCON GENERICS