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Serving leading biopharmaceutical companies globally:

Fish and Richardson
Harvard Business School
US Army

Generated: December 11, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 016659

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NDA 016659 describes NORINYL 1+50 28-DAY, which is a drug marketed by Actavis Labs Ut Inc and is included in one NDA. It is available from two suppliers. Additional details are available on the NORINYL 1+50 28-DAY profile page.

The generic ingredient in NORINYL 1+50 28-DAY is mestranol; norethindrone. There are eleven drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the mestranol; norethindrone profile page.

Summary for 016659

Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 016659

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NORINYL 1+50 28-DAY mestranol; norethindrone TABLET;ORAL-28 016659 NDA Watson Pharma, Inc. 52544-245 52544-245-31 3 BLISTER PACK in 1 CARTON (52544-245-31) > 1 KIT in 1 BLISTER PACK
NORINYL 1+50 28-DAY mestranol; norethindrone TABLET;ORAL-28 016659 NDA Actavis Pharma, Inc. 52544-265 52544-265-31 3 BLISTER PACK in 1 CARTON (52544-265-31) > 1 KIT in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORAL-28Strength0.05MG;1MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
US Department of Justice
Boehringer Ingelheim

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