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Last Updated: April 22, 2024

Details for New Drug Application (NDA): 019781


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

The generic ingredient in PROMETRIUM 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 019781
Tradename:PROMETRIUM
Applicant:Virtus
Ingredient:progesterone
Patents:0
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 Bryant Ranch Prepack 63629-7475 63629-7475-1 30 CAPSULE in 1 BOTTLE (63629-7475-1)
PROMETRIUM progesterone CAPSULE;ORAL 019781 NDA Bryant Ranch Prepack 63629-7475 63629-7475-2 28 CAPSULE in 1 BOTTLE (63629-7475-2)

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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