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Details for New Drug Application (NDA): 072694

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NDA 072694 describes GENCEPT 10/11-21, which is a drug marketed by Barr and is included in one NDA. Additional details are available on the GENCEPT 10/11-21 profile page.

The generic ingredient in GENCEPT 10/11-21 is ethinyl estradiol; norethindrone. There are twenty-six drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone profile page.

Summary for NDA: 072694

GENCEPT 10/11-21
ethinyl estradiol; norethindrone

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORAL-21Strength0.035MG,0.035MG;0.5MG,1MG
Approval Date:Feb 28, 1992TE:RLD:No

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