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Last Updated: March 19, 2026

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 sixteen NDAs. It is available from twenty-four 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-seven 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

Pharmacology for NDA: 208801

Medical Subject Heading (MeSH) Categories for 208801

Progestins

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:	RX	Dosage:	CAPSULE;ORAL			Strength	100MG
Approval Date:	Feb 28, 2017	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	200MG
Approval Date:	Feb 28, 2017	TE:	AB	RLD:	No

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