An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 085635
Company: PFIZER

Products on ANDA 085635

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DEPO-TESTOSTERONE	TESTOSTERONE CYPIONATE	50MG/ML	INJECTABLE;INJECTION	Discontinued	None	No	No
DEPO-TESTOSTERONE	TESTOSTERONE CYPIONATE	100MG/ML	INJECTABLE;INJECTION	Prescription	AO	Yes	Yes
DEPO-TESTOSTERONE	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE;INJECTION	Prescription	AO	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 085635

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/25/1979	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-45	Labeling-Package Insert		Label is not available on this site.
08/01/2018	SUPPL-40	Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/085635s040lbl.pdf
06/18/2025	SUPPL-39	Labeling-Package Insert		Label is not available on this site.
01/09/2017	SUPPL-38	Labeling-Package Insert		Label is not available on this site.
10/25/2016	SUPPL-35	Labeling-Package Insert		Label is not available on this site.
08/12/2016	SUPPL-32	Labeling		Label is not available on this site.
05/11/2015	SUPPL-30	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/085635s030lbl.pdf
06/19/2014	SUPPL-29	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/085635s029lbl.pdf
07/28/2025	SUPPL-28	Manufacturing (CMC)-Formulation	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/085635s028lbl.pdf
02/17/2015	SUPPL-26	Labeling-Package Insert		Label is not available on this site.
05/28/2002	SUPPL-16	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
07/03/2002	SUPPL-15	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
04/05/2000	SUPPL-14	Manufacturing (CMC)-Facility		Label is not available on this site.
04/30/1997	SUPPL-13	Labeling	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/anda/97/085635Orig1s013.pdf
05/03/1996	SUPPL-12	Labeling	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/anda/96/085635Orig1s012.pdf
07/11/1991	SUPPL-11	Labeling	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/085635Orig1s011.pdf
06/13/1984	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
11/03/1982	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.

Labels for ANDA 085635

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/28/2025	SUPPL-28	Manufacturing (CMC)-Formulation	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/085635s028lbl.pdf
08/01/2018	SUPPL-40	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/085635s040lbl.pdf
08/01/2018	SUPPL-40	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/085635s040lbl.pdf
05/11/2015	SUPPL-30	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/085635s030lbl.pdf
06/19/2014	SUPPL-29	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/085635s029lbl.pdf

Therapeutic Equivalents for ANDA 085635

DEPO-TESTOSTERONE

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

Top