NDA 020874

PHARMACIA AND UPJOHN

FDA Drug Application

Application #020874

Documents

• Letter: 2000-10-05
• Label: 2000-10-05
• Review: 2005-04-11

Application Sponsors

NDA 020874

PHARMACIA AND UPJOHN

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INTRAMUSCULAR

5MG/0.5ML;25MG/0.5ML

0

LUNELLE

ESTRADIOL CYPIONATE; MEDROXYPROGESTERONE ACETATE

FDA Submissions

TYPE 4; Type 4 - New Combination	ORIG	1	AP	2000-10-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2002-04-26	STANDARD

Submissions Property Types

ORIG	1	Null	0
SUPPL	2	Null	0

CDER Filings

PHARMACIA AND UPJOHN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20874
            [companyName] => PHARMACIA AND UPJOHN
            [docInserts] => ["",""]
            [products] => [{"drugName":"LUNELLE","activeIngredients":"ESTRADIOL CYPIONATE; MEDROXYPROGESTERONE ACETATE","strength":"5MG\/0.5ML;25MG\/0.5ML","dosageForm":"INJECTABLE;INTRAMUSCULAR","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"10\/05\/2000","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2000\\\/20874lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"LUNELLE","submission":"ESTRADIOL CYPIONATE; MEDROXYPROGESTERONE ACETATE","actionType":"5MG\/0.5ML;25MG\/0.5ML","submissionClassification":"INJECTABLE;INTRAMUSCULAR","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2000-10-05
        )

)