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Serving 500+ biopharmaceutical companies globally:

Johnson and Johnson
US Army
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Chinese Patent Office
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Harvard Business School

Generated: June 27, 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. Nine suppliers are listed for this compound. Additional details are available on the estradiol; norethindrone acetate profile page.

Summary for NDA: 203339

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
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
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 500+ biopharmaceutical companies globally:

Boehringer Ingelheim
Express Scripts
Fish and Richardson
Farmers Insurance

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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