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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 200456


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NDA 200456 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 200456
Tradename:PROGESTERONE
Applicant:Sofgen Pharms
Ingredient:progesterone
Patents:0
Pharmacology for NDA: 200456
Medical Subject Heading (MeSH) Categories for 200456
Suppliers and Packaging for NDA: 200456
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PROGESTERONE progesterone CAPSULE;ORAL 200456 ANDA Proficient Rx LP 71205-293 71205-293-30 30 CAPSULE in 1 BOTTLE, PLASTIC (71205-293-30)
PROGESTERONE progesterone CAPSULE;ORAL 200456 ANDA Proficient Rx LP 71205-293 71205-293-60 60 CAPSULE in 1 BOTTLE, PLASTIC (71205-293-60)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength100MG
Approval Date:Sep 28, 2012TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength200MG
Approval Date:Sep 28, 2012TE:ABRLD:No

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