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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson

Generated: May 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 201512

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NDA 201512 describes PIRMELLA 1/35, which is a drug marketed by Lupin Ltd and is included in one NDA. It is available from one supplier. Additional details are available on the PIRMELLA 1/35 profile page.

The generic ingredient in PIRMELLA 1/35 is ethinyl estradiol; 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 ethinyl estradiol; norethindrone profile page.
Summary for 201512
Tradename:PIRMELLA 1/35
Applicant:Lupin Ltd
Ingredient:ethinyl estradiol; norethindrone
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 201512
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PIRMELLA 1/35 ethinyl estradiol; norethindrone TABLET;ORAL-28 201512 ANDA Lupin Pharmaceuticals, Inc. 68180-893 N 68180-893-13

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORAL-28Strength0.035MG;1MG
Approval Date:Apr 24, 2013TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
US Department of Justice
Daiichi Sankyo

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