Drugs@FDA: FDA-Approved Drugs

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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
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
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
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
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	040615	SANDOZ
TESTOSTERONE CYPIONATE	TESTOSTERONE CYPIONATE	100MG/ML	INJECTABLE;INJECTION	Prescription	No	AO	201720	SUN PHARM INDS LTD
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	040615	SANDOZ
TESTOSTERONE CYPIONATE	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE;INJECTION	Prescription	No	AO	201720	SUN PHARM INDS LTD
TESTOSTERONE CYPIONATE	TESTOSTERONE CYPIONATE	200MG/ML	INJECTABLE;INJECTION	Prescription	No	AO	086030	WATSON PHARMS INC
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