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Last Updated: September 19, 2020

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Details for New Drug Application (NDA): 075809

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NDA 075809 describes ENPRESSE-28, which is a drug marketed by Duramed Pharms Barr and is included in one NDA. It is available from one supplier. Additional details are available on the ENPRESSE-28 profile page.

The generic ingredient in ENPRESSE-28 is ethinyl estradiol; levonorgestrel. There are twenty-six drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; levonorgestrel profile page.
Summary for 075809
Tradename:ENPRESSE-28
Applicant:Duramed Pharms Barr
Ingredient:ethinyl estradiol; levonorgestrel
Patents:0
Suppliers and Packaging for NDA: 075809
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ENPRESSE-21 ethinyl estradiol; levonorgestrel TABLET;ORAL-21 075809 ANDA Teva Pharmaceuticals USA, Inc. 0555-9047 0555-9047-58 6 POUCH in 1 CARTON (0555-9047-58) > 1 BLISTER PACK in 1 POUCH > 1 KIT in 1 BLISTER PACK
ENPRESSE-28 ethinyl estradiol; levonorgestrel TABLET;ORAL-28 075809 ANDA Teva Pharmaceuticals USA, Inc. 0555-9047 0555-9047-58 6 POUCH in 1 CARTON (0555-9047-58) > 1 BLISTER PACK in 1 POUCH > 1 KIT in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORAL-21Strength0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG
Approval Date:Jul 16, 2001TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORAL-28Strength0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG
Approval Date:Jul 16, 2001TE:ABRLD:No

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