Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving hundreds of leading biopharmaceutical companies globally:

Moodys
Daiichi Sankyo
McKesson
Deloitte
Cerilliant
Cantor Fitzgerald
Argus Health
US Army
Mallinckrodt

Generated: April 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 200456

« Back to Dashboard

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-five 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 N 17478-766-10
PROGESTERONE progesterone CAPSULE;ORAL 200456 ANDA Akorn, Inc. 17478-767 N 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

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
Chubb
Federal Trade Commission
Accenture
Argus Health
Cipla
Fuji
AstraZeneca
Boehringer Ingelheim

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.