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Last Updated: November 21, 2024

Details for New Drug Application (NDA): 207724


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NDA 207724 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-one 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-five suppliers are listed for this compound. Additional details are available on the progesterone profile page.
Summary for 207724
Tradename:PROGESTERONE
Applicant:Amneal Pharms Ny
Ingredient:progesterone
Patents:0
Pharmacology for NDA: 207724
Medical Subject Heading (MeSH) Categories for 207724
Suppliers and Packaging for NDA: 207724
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PROGESTERONE progesterone CAPSULE;ORAL 207724 ANDA Amneal Pharmaceuticals LLC 65162-807 65162-807-10 100 CAPSULE in 1 BOTTLE (65162-807-10)
PROGESTERONE progesterone CAPSULE;ORAL 207724 ANDA Amneal Pharmaceuticals LLC 65162-807 65162-807-50 500 CAPSULE in 1 BOTTLE (65162-807-50)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength100MG
Approval Date:Sep 7, 2017TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength200MG
Approval Date:Sep 7, 2017TE:ABRLD:No

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