Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091120
Company: HIKMA FARMACEUTICA

Products on ANDA 091120

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 091120

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/18/2012	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
07/11/2025	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
10/29/2020	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
09/08/2015	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
11/21/2014	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 091120

TESTOSTERONE ENANTHATE

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

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
TESTOSTERONE ENANTHATE	TESTOSTERONE ENANTHATE	200MG/ML	INJECTABLE;INJECTION	Prescription	No	AO	212659	EUGIA PHARMA
TESTOSTERONE ENANTHATE	TESTOSTERONE ENANTHATE	200MG/ML	INJECTABLE;INJECTION	Prescription	No	AO	091120	HIKMA FARMACEUTICA
TESTOSTERONE ENANTHATE	TESTOSTERONE ENANTHATE	200MG/ML	INJECTABLE;INJECTION	Prescription	No	AO	040575	NEXUS