Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 219478
Company: BPI LABS

Products on ANDA 219478

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TESTOSTERONE CYPIONATE	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE;INJECTION	Prescription	AO	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 219478

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/03/2026	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 219478

TESTOSTERONE CYPIONATE

INJECTABLE;INJECTION; 200MG/ML
TE Code = AO

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DEPO-TESTOSTERONE	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE;INJECTION	Prescription	Yes	AO	085635	PFIZER
TESTOSTERONE CYPIONATE	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE;INJECTION	Prescription	No	AO	207742	AM REGENT
TESTOSTERONE CYPIONATE	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE;INJECTION	Prescription	No	AO	219478	BPI LABS
TESTOSTERONE CYPIONATE	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE;INJECTION	Prescription	No	AO	210362	CIPLA
TESTOSTERONE CYPIONATE	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE;INJECTION	Prescription	No	AO	211817	EUGIA PHARMA
TESTOSTERONE CYPIONATE	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE;INJECTION	Prescription	No	AO	090387	HIKMA
TESTOSTERONE CYPIONATE	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE;INJECTION	Prescription	No	AO	091244	HIKMA FARMACEUTICA
TESTOSTERONE CYPIONATE	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE;INJECTION	Prescription	No	AO	040530	PADAGIS US
TESTOSTERONE CYPIONATE	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE;INJECTION	Prescription	No	AO	206368	WILSHIRE PHARMS INC
TESTOSTERONE CYPIONATE	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE;INJECTION	Prescription	No	AO	215351	XIROMED