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Last Updated: July 5, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 016954

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NDA 016954 describes MICRONOR, which is a drug marketed by Janssen Pharms and is included in one NDA. It is available from two suppliers. Additional details are available on the MICRONOR profile page.

The generic ingredient in MICRONOR is 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 norethindrone profile page.
Summary for 016954
Applicant:Janssen Pharms
Formulation / Manufacturing:see details
Pharmacology for NDA: 016954
Medical Subject Heading (MeSH) Categories for 016954
Suppliers and Packaging for NDA: 016954
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MICRONOR norethindrone TABLET;ORAL-28 016954 NDA Janssen Pharmaceuticals, Inc. 50458-194 50458-194-06 6 BLISTER PACK in 1 CARTON (50458-194-06) > 28 TABLET in 1 BLISTER PACK (50458-194-28)
MICRONOR norethindrone TABLET;ORAL-28 016954 NDA Actavis Pharma, Inc. 52544-892 52544-892-28 6 BLISTER PACK in 1 BOX (52544-892-28) > 28 TABLET in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORAL-28Strength0.35MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

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