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Generated: June 20, 2019

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Details for New Drug Application (NDA): 018985

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NDA 018985 describes ORTHO-NOVUM 7/7/7-28, which is a drug marketed by Janssen Pharms and is included in one NDA. It is available from four suppliers. Additional details are available on the ORTHO-NOVUM 7/7/7-28 profile page.

The generic ingredient in ORTHO-NOVUM 7/7/7-28 is ethinyl estradiol; norethindrone. There are twenty-six drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone profile page.
Summary for 018985
Tradename:ORTHO-NOVUM 7/7/7-28
Applicant:Janssen Pharms
Ingredient:ethinyl estradiol; norethindrone
Suppliers and Packaging for NDA: 018985
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ORTHO-NOVUM 7/7/7-21 ethinyl estradiol; norethindrone TABLET;ORAL-21 018985 NDA A-S Medication Solutions LLC 50090-0159 50090-0159-1 6 DIALPACK in 1 CARTON (50090-0159-1) > 1 KIT in 1 DIALPACK
ORTHO-NOVUM 7/7/7-21 ethinyl estradiol; norethindrone TABLET;ORAL-21 018985 NDA Janssen Pharmaceuticals, Inc. 50458-178 50458-178-06 6 BLISTER PACK in 1 CARTON (50458-178-06) > 1 KIT in 1 BLISTER PACK (50458-178-28)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORAL-21Strength0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG
Approval Date:Apr 4, 1984TE: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:Apr 4, 1984TE:ABRLD:Yes

Expired US Patents for NDA 018985

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