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Serving leading biopharmaceutical companies globally:

AstraZeneca
Accenture
Cerilliant
Colorcon
Novartis
Medtronic
Argus Health
US Department of Justice
US Army
QuintilesIMS

Generated: January 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091204

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NDA 091204 describes WERA, which is a drug marketed by Novast Labs Ltd and is included in one NDA. It is available from one supplier. Additional details are available on the WERA profile page.

The generic ingredient in WERA 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 091204
Tradename:WERA
Applicant:Novast Labs Ltd
Ingredient:ethinyl estradiol; norethindrone
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 091204
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
WERA ethinyl estradiol; norethindrone TABLET;ORAL-28 091204 ANDA Northstar Rx LLC 16714-370 16714-370-03 3 BLISTER PACK in 1 CARTON (16714-370-03) > 1 KIT in 1 BLISTER PACK
WERA ethinyl estradiol; norethindrone TABLET;ORAL-28 091204 ANDA Northstar Rx LLC 16714-370 16714-370-01 1 BLISTER PACK in 1 PACKET (16714-370-01) > 1 KIT in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORAL-28Strength0.035MG;0.5MG
Approval Date:Mar 27, 2012TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

UBS
Novartis
Express Scripts
Colorcon
Julphar
Queensland Health
Deloitte
Fuji
Baxter

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