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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
Argus Health

Generated: February 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076177

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NDA 076177 describes CAMILA, which is a drug marketed by Mayne Pharma and is included in one NDA. It is available from three suppliers. Additional details are available on the CAMILA profile page.

The generic ingredient in CAMILA 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 076177
Applicant:Mayne Pharma
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details
Pharmacology for NDA: 076177
Ingredient-typeProgesterone Congeners
Medical Subject Heading (MeSH) Categories for 076177
Suppliers and Packaging for NDA: 076177
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CAMILA norethindrone TABLET;ORAL-28 076177 ANDA Teva Pharmaceuticals USA, Inc. 0555-0715 N 0555-0715-58
CAMILA norethindrone TABLET;ORAL-28 076177 ANDA Mayne Pharma Inc. 51862-102 N 51862-102-06

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORAL-28Strength0.35MG
Approval Date:Oct 21, 2002TE:AB1RLD:No

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