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Last Updated: March 28, 2024

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, Dr Reddys, Eugia Pharma, Sofgen Pharms, Teva Pharms, Xiromed, Accord Hlthcare, Actavis Labs Ut Inc, Am Regent, Fresenius Kabi Usa, Hikma Farmaceutica, and Lilly, and is included in fifteen NDAs. It is available from twenty 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-four suppliers are listed for this compound. Additional details are available on the progesterone profile page.
Summary for 210965
Tradename:PROGESTERONE
Applicant:Eugia Pharma
Ingredient:progesterone
Patents:0
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 Eugia US 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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