Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 040575
Company: NEXUS

Products on ANDA 040575

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	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040575

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/14/2006	ORIG-1	Approval			Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/anda/2006/040575Orig1s000BioeqR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/30/2020	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
09/02/2015	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
01/06/2009	SUPPL-2	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 040575

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
TESTOSTERONE ENANTHATE	TESTOSTERONE ENANTHATE	200MG/ML	INJECTABLE;INJECTION	Prescription	No	AO	085598	WATSON PHARMS INC