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Serving leading biopharmaceutical companies globally:

Express Scripts
US Army
Farmers Insurance
Daiichi Sankyo

Generated: January 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 207304

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NDA 207304 describes INCASSIA, which is a drug marketed by Aurobindo Pharma Ltd and is included in one NDA. It is available from one supplier. Additional details are available on the INCASSIA profile page.

The generic ingredient in INCASSIA 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 207304
Applicant:Aurobindo Pharma Ltd
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details
Pharmacology for NDA: 207304
Ingredient-typeProgesterone Congeners
Medical Subject Heading (MeSH) Categories for 207304
Suppliers and Packaging for NDA: 207304
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
INCASSIA norethindrone TABLET;ORAL-28 207304 ANDA Aurobindo Pharma Limited 65862-925 65862-925-92 6 POUCH in 1 CARTON (65862-925-92) > 1 TABLET in 1 POUCH
INCASSIA norethindrone TABLET;ORAL-28 207304 ANDA Aurobindo Pharma Limited 65862-925 65862-925-88 3 POUCH in 1 CARTON (65862-925-88) > 1 TABLET in 1 POUCH

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORAL-28Strength0.35MG
Approval Date:Sep 23, 2016TE:AB1RLD:No

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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
Chinese Patent Office
Argus Health
Fish and Richardson

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