You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: March 29, 2024

Details for New Drug Application (NDA): 203339


✉ Email this page to a colleague

« Back to Dashboard


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 203339
Tradename:AMABELZ
Applicant:Lupin Ltd
Ingredient:estradiol; norethindrone acetate
Patents:0
Pharmacology for NDA: 203339
Mechanism of ActionEstrogen Receptor Agonists
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 68180-829-73 3 POUCH in 1 CARTON (68180-829-73) / 1 BLISTER PACK in 1 POUCH / 28 TABLET in 1 BLISTER PACK

Profile for product number 001

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

Profile for product number 002

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

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

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 verification 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.