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BioPharmaceutical Business Intelligence

  • Analyze global market entry opportunities
  • Identify first generic entrants
  • Obtain formulation and manufacturing information

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Serving leading biopharmaceutical companies globally:

Colorcon
Cipla
Daiichi Sankyo
QuintilesIMS
Fuji
Boehringer Ingelheim
Cerilliant
Queensland Health
Argus Health
Baxter

Generated: December 18, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203339

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NDA 203339 describes AMABELZ, 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 AMABELZ profile page.

The generic ingredient in AMABELZ is estradiol; norethindrone acetate. There are seventy-five drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the estradiol; norethindrone acetate profile page.

Summary for 203339

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 203339

Suppliers and Packaging for NDA: 203339

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMABELZ estradiol; norethindrone acetate TABLET;ORAL 203339 ANDA Lupin Pharmaceuticals, Inc. 68180-829 68180-829-13 3 POUCH in 1 CARTON (68180-829-13) > 1 BLISTER PACK in 1 POUCH (68180-829-11) > 28 TABLET in 1 BLISTER PACK
AMABELZ estradiol; norethindrone acetate TABLET;ORAL 203339 ANDA Lupin Pharmaceuticals, Inc. 68180-830 68180-830-13 3 POUCH in 1 CARTON (68180-830-13) > 1 BLISTER PACK in 1 POUCH (68180-830-11) > 28 TABLET in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.5MG;0.1MG
Approval Date:Jun 20, 2016TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG;0.5MG
Approval Date:Jun 20, 2016TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

Healthtrust
Daiichi Sankyo
Fuji
Argus Health
McKesson
Federal Trade Commission
Baxter
Deloitte
Queensland Health
Cipla

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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