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Last Updated: November 30, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 210965

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NDA 210965 describes PROGESTERONE, which is a drug marketed by Amneal Pharms Ny, Bionpharma Inc, Dr Reddys, Eugia Pharma, Sofgen Pharms, Teva Pharms, Xiromed, Actavis Labs Ut Inc, Am Regent, Fresenius Kabi Usa, Hikma Farmaceutica, and Lilly, and is included in thirteen NDAs. It is available from seventeen suppliers. Additional details are available on the PROGESTERONE profile page.

The generic ingredient in PROGESTERONE is progesterone. There are fifty-seven drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the progesterone profile page.
Summary for 210965
Applicant:Eugia Pharma
Formulation / Manufacturing:see details
Pharmacology for NDA: 210965
Medical Subject Heading (MeSH) Categories for 210965
Suppliers and Packaging for NDA: 210965
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PROGESTERONE progesterone INJECTABLE;INJECTION 210965 ANDA AuroMedics Pharma LLC 55150-306 55150-306-10 10 mL in 1 VIAL, MULTI-DOSE (55150-306-10)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength50MG/ML
Approval Date:Dec 6, 2018TE:AORLD:No

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