You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: November 23, 2024

Details for New Drug Application (NDA): 210612


✉ Email this page to a colleague

« Back to Dashboard


NDA 210612 describes ESTRADIOL AND NORETHINDRONE ACETATE, which is a drug marketed by Barr, Breckenridge Pharm, Naari Pte Ltd, Novast Labs, Teva Pharms Usa, and Xiromed, and is included in six NDAs. It is available from five suppliers. Additional details are available on the ESTRADIOL AND NORETHINDRONE ACETATE profile page.

The generic ingredient in ESTRADIOL AND NORETHINDRONE ACETATE 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 210612
Pharmacology for NDA: 210612
Mechanism of ActionEstrogen Receptor Agonists
Suppliers and Packaging for NDA: 210612
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ESTRADIOL AND NORETHINDRONE ACETATE estradiol; norethindrone acetate TABLET;ORAL 210612 ANDA Ingenus Pharmaceuticals, LLC 50742-657 50742-657-28 1 BLISTER PACK in 1 CARTON (50742-657-28) / 28 TABLET in 1 BLISTER PACK (50742-657-01)
ESTRADIOL AND NORETHINDRONE ACETATE estradiol; norethindrone acetate TABLET;ORAL 210612 ANDA Ingenus Pharmaceuticals, LLC 50742-657 50742-657-68 6 BLISTER PACK in 1 CARTON (50742-657-68) / 28 TABLET in 1 BLISTER PACK (50742-657-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.5MG;0.1MG
Approval Date:Apr 3, 2019TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG;0.5MG
Approval Date:Apr 3, 2019TE:ABRLD: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.