Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 085470
Company: PHARMACIA AND UPJOHN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DEPO-ESTRADIOL ESTRADIOL CYPIONATE 1MG/ML INJECTABLE;INJECTION Discontinued None No No
DEPO-ESTRADIOL ESTRADIOL CYPIONATE 3MG/ML INJECTABLE;INJECTION Discontinued None No No
DEPO-ESTRADIOL ESTRADIOL CYPIONATE 5MG/ML INJECTABLE;INJECTION Prescription None 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
08/15/1979 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
05/03/2019 SUPPL-23 Labeling-Package Insert

Label is not available on this site.

06/15/2005 SUPPL-15 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/085470s015lbl.pdf
05/28/2002 SUPPL-13 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

04/05/2000 SUPPL-12 Manufacturing (CMC)-Facility

Label is not available on this site.

06/01/1998 SUPPL-10 Labeling

Label is not available on this site.

07/01/1982 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

07/01/1982 SUPPL-3 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
06/15/2005 SUPPL-15 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/085470s015lbl.pdf

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