Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020874
Company: PHARMACIA AND UPJOHN

Products on NDA 020874

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	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020874

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.

Labels for NDA 020874

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