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Generated: January 24, 2019

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Details for New Drug Application (NDA): 200900

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NDA 200900 describes PROGESTERONE, which is a drug marketed by Amneal Pharms Ny, Bionpharma Inc, Dr Reddys Labs Inc, Eugia Pharma, Sandoz Inc, Sofgen Pharms, Teva Pharms, Actavis Labs Ut Inc, Fresenius Kabi Usa, Hikma Farmaceutica, Lilly, and Luitpold, and is included in thirteen NDAs. It is available from nineteen suppliers. Additional details are available on the PROGESTERONE profile page.

The generic ingredient in PROGESTERONE 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 200900
Tradename:PROGESTERONE
Applicant:Bionpharma Inc
Ingredient:progesterone
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 200900
Medical Subject Heading (MeSH) Categories for 200900
Suppliers and Packaging for NDA: 200900
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PROGESTERONE progesterone CAPSULE;ORAL 200900 ANDA Banner Pharmacaps 10888-7135 10888-7135-2 100 CAPSULE in 1 BOTTLE (10888-7135-2)
PROGESTERONE progesterone CAPSULE;ORAL 200900 ANDA Banner Pharmacaps 10888-7136 10888-7136-2 100 CAPSULE in 1 BOTTLE (10888-7136-2)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength100MG
Approval Date:Aug 16, 2013TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength200MG
Approval Date:Aug 16, 2013TE:ABRLD:No

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