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Generated: May 27, 2017

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. Eighteen suppliers are listed for this compound. Additional details are available on the norethindrone profile page.

Summary for NDA: 016954

Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details

Pharmacology for NDA: 016954

Ingredient-typeProgesterone Congeners

Suppliers and Packaging for NDA: 016954

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TABLET;ORAL-28 016954 NDA Janssen Pharmaceuticals, Inc. 50458-194 50458-194-12 12 BLISTER PACK in 1 CARTON (50458-194-12) > 28 TABLET in 1 BLISTER PACK (50458-194-00)
TABLET;ORAL-28 016954 NDA Janssen Pharmaceuticals, Inc. 50458-194 50458-194-16 6 BLISTER PACK in 1 CARTON (50458-194-16) > 28 TABLET in 1 BLISTER PACK (50458-194-00)

Summary 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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