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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 072695


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NDA 072695 describes NORTREL 0.5/35-28, which is a drug marketed by Barr and is included in one NDA. It is available from two suppliers. Additional details are available on the NORTREL 0.5/35-28 profile page.

The generic ingredient in NORTREL 0.5/35-28 is ethinyl estradiol; norethindrone. There are twenty-six drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone profile page.
Summary for 072695
Tradename:NORTREL 0.5/35-28
Applicant:Barr
Ingredient:ethinyl estradiol; norethindrone
Patents:0
Suppliers and Packaging for NDA: 072695
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NORTREL 0.5/35-28 ethinyl estradiol; norethindrone TABLET;ORAL-28 072695 ANDA Teva Pharmaceuticals USA, Inc. 0555-9008 0555-9008-67 3 POUCH in 1 CARTON (0555-9008-67) / 1 BLISTER PACK in 1 POUCH (0555-9008-79) / 1 KIT in 1 BLISTER PACK
NORTREL 0.5/35-28 ethinyl estradiol; norethindrone TABLET;ORAL-28 072695 ANDA A-S Medication Solutions 50090-3229 50090-3229-0 1 KIT in 1 KIT (50090-3229-0)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORAL-28Strength0.035MG;0.5MG
Approval Date:Feb 28, 1992TE:ABRLD:No

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