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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091244
Company: HIKMA FARMACEUTICA

Safety Labeling Change Order Letter

Products on ANDA 091244

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 091244

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/01/2012	ORIG-1	Approval			Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/091244Orig1s000Approv.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/11/2025	SUPPL-23	Labeling-Package Insert		Label is not available on this site.
07/09/2025	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
07/09/2025	SUPPL-12	Labeling-Container/Carton Labels		Label is not available on this site.
03/27/2017	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
07/22/2015	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
05/11/2015	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
06/19/2014	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
07/26/2016	SUPPL-2			Label is not available on this site.

Therapeutic Equivalents for ANDA 091244

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	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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