Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020874
Company: PHARMACIA AND UPJOHN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LUNELLE ESTRADIOL CYPIONATE; MEDROXYPROGESTERONE ACETATE 5MG/0.5ML;25MG/0.5ML INJECTABLE;INTRAMUSCULAR Discontinued None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
10/05/2000 ORIG-1 Approval Type 4 - New Combination STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20874lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20874ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-874_Lunelle.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/26/2002 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

06/07/2001 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/05/2000 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20874lbl.pdf

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