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Last Updated: January 29, 2022

DrugPatentWatch Database Preview

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 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 207724
Applicant:Amneal Pharms Ny
Formulation / Manufacturing:see details
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 A-S Medication Solutions 50090-4656 50090-4656-0 10 CAPSULE in 1 BOTTLE (50090-4656-0)
PROGESTERONE progesterone CAPSULE;ORAL 207724 ANDA A-S Medication Solutions 50090-4656 50090-4656-1 90 CAPSULE in 1 BOTTLE (50090-4656-1)

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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