Details for New Drug Application (NDA): 204296

NDA 204296 describes DROSPIRENONE AND ETHINYL ESTRADIOL, which is a drug marketed by Barr, Glenmark Pharms Ltd, Hetero Labs, Hlthcare, Jubilant Cadista, Watson Labs, Xiromed, Apotex, Dr Reddys Labs Sa, Lupin Ltd, and Naari Pte Ltd, and is included in sixteen NDAs. It is available from ten suppliers. Additional details are available on the DROSPIRENONE AND ETHINYL ESTRADIOL profile page.

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

Summary for 204296

Tradename:	DROSPIRENONE AND ETHINYL ESTRADIOL
Applicant:	Glenmark Pharms Ltd
Ingredient:	drospirenone; ethinyl estradiol
Patents:	0

Suppliers and Packaging for NDA: 204296

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DROSPIRENONE AND ETHINYL ESTRADIOL	drospirenone; ethinyl estradiol	TABLET;ORAL	204296	ANDA	A-S Medication Solutions	50090-2594	50090-2594-0	1 KIT in 1 KIT (50090-2594-0)
DROSPIRENONE AND ETHINYL ESTRADIOL	drospirenone; ethinyl estradiol	TABLET;ORAL	204296	ANDA	RPK Pharmaceuticals, Inc.	53002-1735	53002-1735-1	1 BLISTER PACK in 1 PACKAGE (53002-1735-1) / 1 KIT in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	3MG;0.02MG
Approval Date:	Aug 17, 2015	TE:	AB	RLD:	No

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