Last Updated: May 3, 2026

Details for New Drug Application (NDA): 216363

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NDA 216363 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, Lilly, and Glenmark Pharms Ltd, and is included in seventeen NDAs. It is available from twenty-five 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-nine suppliers are listed for this compound. Additional details are available on the progesterone profile page.

Summary for 216363

Tradename:	PROGESTERONE
Applicant:	Glenmark Pharms Ltd
Ingredient:	progesterone
Patents:	0

Pharmacology for NDA: 216363

Medical Subject Heading (MeSH) Categories for 216363

Progestins

Suppliers and Packaging for NDA: 216363

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PROGESTERONE	progesterone	INSERT;VAGINAL	216363	ANDA	Glenmark Pharmaceuticals Inc., USA	68462-175	68462-175-33	21 BLISTER PACK in 1 CARTON (68462-175-33) / 1 INSERT in 1 BLISTER PACK (68462-175-40)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INSERT;VAGINAL			Strength	100MG
Approval Date:	Apr 8, 2026	TE:	AB	RLD:	No

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