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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 208801


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NDA 208801 describes PROGESTERONE, which is a drug marketed by Amneal Pharms Ny, Bionpharma, Dr Reddys, Eugia Pharma, Sofgen Pharms, Teva Pharms, Xiromed, Accord Hlthcare, Actavis Labs Ut Inc, Am Regent, Fresenius Kabi Usa, Hikma Farmaceutica, and Lilly, and is included in fifteen NDAs. It is available from twenty 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-four suppliers are listed for this compound. Additional details are available on the progesterone profile page.
Summary for 208801
Tradename:PROGESTERONE
Applicant:Dr Reddys
Ingredient:progesterone
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 208801
Medical Subject Heading (MeSH) Categories for 208801
Suppliers and Packaging for NDA: 208801
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PROGESTERONE progesterone CAPSULE;ORAL 208801 ANDA Dr. Reddy?s Laboratories, Inc. 43598-349 43598-349-01 100 CAPSULE in 1 BOTTLE (43598-349-01)
PROGESTERONE progesterone CAPSULE;ORAL 208801 ANDA Dr. Reddy?s Laboratories, Inc. 43598-350 43598-350-01 100 CAPSULE in 1 BOTTLE (43598-350-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength100MG
Approval Date:Feb 28, 2017TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength200MG
Approval Date:Feb 28, 2017TE:ABRLD:No

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