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Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
Boehringer Ingelheim

Generated: April 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 019781

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NDA 019781 describes PROMETRIUM, which is a drug marketed by Virtus Pharms and is included in one NDA. It is available from five suppliers. Additional details are available on the PROMETRIUM profile page.

The generic ingredient in PROMETRIUM is progesterone. There are fifty-five drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the progesterone profile page.
Summary for 019781
Applicant:Virtus Pharms
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details
Pharmacology for NDA: 019781
Medical Subject Heading (MeSH) Categories for 019781
Suppliers and Packaging for NDA: 019781
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PROMETRIUM progesterone CAPSULE;ORAL 019781 NDA AbbVie Inc. 0032-1708 N 0032-1708-01
PROMETRIUM progesterone CAPSULE;ORAL 019781 NDA AbbVie Inc. 0032-1711 N 0032-1711-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength100MG
Approval Date:May 14, 1998TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength200MG
Approval Date:Oct 15, 1999TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength300MG
Approval Date:Oct 15, 1999TE:RLD:No

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Harvard Business School
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US Army
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Daiichi Sankyo

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