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Last Updated: February 17, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075478


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NDA 075478 describes NORTREL 7/7/7, which is a drug marketed by Barr and is included in one NDA. It is available from one supplier. Additional details are available on the NORTREL 7/7/7 profile page.

The generic ingredient in NORTREL 7/7/7 is ethinyl estradiol; norethindrone. There are twenty-six drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone profile page.
Summary for 075478
Tradename:NORTREL 7/7/7
Applicant:Barr
Ingredient:ethinyl estradiol; norethindrone
Patents:0
Suppliers and Packaging for NDA: 075478
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NORTREL 7/7/7 ethinyl estradiol; norethindrone TABLET;ORAL-21 075478 ANDA Teva Pharmaceuticals USA, Inc. 0555-9012 0555-9012-58 6 POUCH in 1 CARTON (0555-9012-58) > 1 BLISTER PACK in 1 POUCH (0555-9012-79) > 1 KIT in 1 BLISTER PACK
NORTREL 7/7/7 ethinyl estradiol; norethindrone TABLET;ORAL-28 075478 ANDA Teva Pharmaceuticals USA, Inc. 0555-9012 0555-9012-58 6 POUCH in 1 CARTON (0555-9012-58) > 1 BLISTER PACK in 1 POUCH (0555-9012-79) > 1 KIT in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORAL-21Strength0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG
Approval Date:Aug 30, 2002TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORAL-28Strength0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG
Approval Date:Aug 30, 2002TE:ABRLD:No

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