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Generated: June 24, 2017

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 seven suppliers. Additional details are available on the PROMETRIUM profile page.

The generic ingredient in PROMETRIUM is progesterone. There are fifty-two drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the progesterone profile page.

Summary for NDA: 019781

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details

Pharmacology for NDA: 019781

Ingredient-typeProgesterone

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 0032-1708-01 100 CAPSULE in 1 BOTTLE (0032-1708-01)
PROMETRIUM
progesterone
CAPSULE;ORAL 019781 NDA AbbVie Inc. 0032-1711 0032-1711-01 100 CAPSULE in 1 BOTTLE (0032-1711-01)

Summary for product number 001

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

Summary for product number 002

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

Summary for product number 003

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


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Serving 500+ biopharmaceutical companies globally:

Dow
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US Army
Cantor Fitzgerald
Argus Health
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McKesson
Merck

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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