Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 085635
Company: PHARMACIA AND UPJOHN
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 No Yes
DEPO-TESTOSTERONE TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE;INJECTION Prescription AO No Yes
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.

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

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 No AO 085635 PHARMACIA AND UPJOHN
TESTOSTERONE CYPIONATE TESTOSTERONE CYPIONATE 100MG/ML INJECTABLE;INJECTION Prescription No AO 210362 CIPLA
TESTOSTERONE CYPIONATE TESTOSTERONE CYPIONATE 100MG/ML INJECTABLE;INJECTION Prescription No AO 040615 SANDOZ INC
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 090387 WEST-WARD PHARMS INT

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 No AO 085635 PHARMACIA AND UPJOHN
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 091244 HIKMA FARMACEUTICA
TESTOSTERONE CYPIONATE TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE;INJECTION Prescription No AO 040530 PADDOCK LLC
TESTOSTERONE CYPIONATE TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE;INJECTION Prescription No AO 040615 SANDOZ INC
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 090387 WEST-WARD PHARMS INT
TESTOSTERONE CYPIONATE TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE;INJECTION Prescription No AO 206368 WILSHIRE PHARMS INC

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