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Last Updated: March 29, 2024

Details for New Drug Application (NDA): 017362


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NDA 017362 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 017362
Tradename:PROGESTERONE
Applicant:Actavis Labs Ut Inc
Ingredient:progesterone
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 017362
Medical Subject Heading (MeSH) Categories for 017362
Suppliers and Packaging for NDA: 017362
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PROGESTERONE progesterone INJECTABLE;INJECTION 017362 NDA Actavis Pharma, Inc. 0591-3128 0591-3128-79 10 mL in 1 VIAL, MULTI-DOSE (0591-3128-79)

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

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