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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090387
Company: HIKMA

Safety Labeling Change Order Letter

Products on ANDA 090387

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TESTOSTERONE CYPIONATE	TESTOSTERONE CYPIONATE	100MG/ML	INJECTABLE;INJECTION	Prescription	AO	No	No
TESTOSTERONE CYPIONATE	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE;INJECTION	Prescription	AO	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 090387

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/15/2010	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/14/2025	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
06/19/2014	SUPPL-5	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 090387

TESTOSTERONE CYPIONATE

INJECTABLE;INJECTION; 100MG/ML
TE Code = AO

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DEPO-TESTOSTERONE	TESTOSTERONE CYPIONATE	100MG/ML	INJECTABLE;INJECTION	Prescription	Yes	AO	085635	PFIZER
TESTOSTERONE CYPIONATE	TESTOSTERONE CYPIONATE	100MG/ML	INJECTABLE;INJECTION	Prescription	No	AO	210362	CIPLA
TESTOSTERONE CYPIONATE	TESTOSTERONE CYPIONATE	100MG/ML	INJECTABLE;INJECTION	Prescription	No	AO	211817	EUGIA PHARMA
TESTOSTERONE CYPIONATE	TESTOSTERONE CYPIONATE	100MG/ML	INJECTABLE;INJECTION	Prescription	No	AO	090387	HIKMA
TESTOSTERONE CYPIONATE	TESTOSTERONE CYPIONATE	100MG/ML	INJECTABLE;INJECTION	Prescription	No	AO	215351	XIROMED

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	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

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