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Serving hundreds of leading biopharmaceutical companies globally:

Moodys
Fish and Richardson
Citi
Daiichi Sankyo
QuintilesIMS
Queensland Health
UBS
Covington
AstraZeneca

Generated: May 22, 2018

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 three 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. Nineteen suppliers are listed for this compound. Additional details are available on the norethindrone profile page.
Summary for 016954
Tradename:MICRONOR
Applicant:Janssen Pharms
Ingredient:norethindrone
Patents:0
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details
Pharmacology for NDA: 016954
Ingredient-typeProgesterone Congeners
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 N 50458-194-06
MICRONOR norethindrone TABLET;ORAL-28 016954 NDA Janssen Pharmaceuticals, Inc. 50458-194 N 50458-194-12

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORAL-28Strength0.35MG
Approval Date:Approved Prior to Jan 1, 1982TE:AB2RLD:Yes

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Serving hundreds of leading biopharmaceutical companies globally:

Deloitte
Mallinckrodt
UBS
Queensland Health
Colorcon
Baxter
Argus Health
Fish and Richardson
Medtronic

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