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Serving leading biopharmaceutical companies globally:

Mallinckrodt
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Boehringer Ingelheim
Queensland Health
UBS
Express Scripts
Fish and Richardson
Baxter
Cerilliant
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Generated: January 20, 2018

DrugPatentWatch Database Preview

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 Inc, Dr Reddys Labs Inc, Sandoz Inc, Sofgen Pharms, Teva Pharms, Actavis Labs Ut Inc, Fresenius Kabi Usa, Hikma Farmaceutica, Lilly, and Luitpold, and is included in eleven NDAs. It is available from sixteen suppliers. Additional details are available on the PROGESTERONE profile page.

The generic ingredient in PROGESTERONE is progesterone. There are fifty-three 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
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details
Pharmacology for NDA: 200456
Ingredient-typeProgesterone
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 Akorn, Inc. 17478-766 17478-766-10 100 CAPSULE in 1 BOTTLE, PLASTIC (17478-766-10)
PROGESTERONE progesterone CAPSULE;ORAL 200456 ANDA Akorn, Inc. 17478-767 17478-767-10 100 CAPSULE in 1 BOTTLE, PLASTIC (17478-767-10)

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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Serving leading biopharmaceutical companies globally:

Julphar
UBS
Express Scripts
Deloitte
Healthtrust
Moodys
Harvard Business School
Chubb
Queensland Health

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