BioPharmaceutical Business Intelligence

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Serving hundreds of leading biopharmaceutical companies globally:

US Army
Boehringer Ingelheim
Cantor Fitzgerald
Express Scripts
US Department of Justice

Generated: March 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075906

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NDA 075906 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 075906
Applicant:Fresenius Kabi Usa
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details
Pharmacology for NDA: 075906
Medical Subject Heading (MeSH) Categories for 075906
Suppliers and Packaging for NDA: 075906
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PROGESTERONE progesterone INJECTABLE;INJECTION 075906 ANDA Fresenius Kabi USA, LLC 63323-261 N 63323-261-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength50MG/ML
Approval Date:Apr 25, 2001TE:AORLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Farmers Insurance
Chinese Patent Office
Argus Health

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