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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. Twenty-two suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone profile page.

Summary for NDA: 072695

Tradename:
NORTREL 0.5/35-28
Applicant:
Barr
Ingredient:
ethinyl estradiol; norethindrone
Patents:0
Formulation / Manufacturing:see details

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 Barr Laboratories Inc. 0555-9008 0555-9008-67 3 BLISTER PACK in 1 CARTON (0555-9008-67) > 1 KIT in 1 BLISTER PACK
NORTREL 0.5/35-28
ethinyl estradiol; norethindrone
TABLET;ORAL-28 072695 ANDA Mayne Pharma Inc. 51862-318 51862-318-03 3 POUCH in 1 CARTON (51862-318-03) > 1 BLISTER PACK in 1 POUCH (51862-318-01) > 1 KIT in 1 BLISTER PACK

Summary 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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