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Last Updated: November 25, 2024

Details for New Drug Application (NDA): 216936

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NDA 216936 describes DROSPIRENONE, which is a drug marketed by Exeltis Usa Inc, Lupin Ltd, Barr, Glenmark Pharms Ltd, Hetero Labs, Hlthcare, Jubilant Cadista, Watson Labs, Xiromed, Apotex, Dr Reddys Labs Sa, Naari Pte Ltd, and Watson Labs Inc, and is included in twenty-one NDAs. There are fifteen patents protecting this drug. Additional details are available on the DROSPIRENONE profile page.

The generic ingredient in DROSPIRENONE is drospirenone; ethinyl estradiol; levomefolate calcium. There are eleven drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the drospirenone; ethinyl estradiol; levomefolate calcium profile page.

Summary for 216936

Tradename:	DROSPIRENONE
Applicant:	Lupin Ltd
Ingredient:	drospirenone
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	4MG
Approval Date:	Sep 30, 2024	TE:	AB	RLD:	No

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