Details for New Drug Application (NDA): 205947

NDA 205947 describes DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM, which is a drug marketed by Lupin Ltd and Watson Labs Inc and is included in three NDAs. It is available from one supplier. Additional details are available on the DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM profile page.

The generic ingredient in DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM 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 205947

Tradename:	DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM
Applicant:	Lupin Ltd
Ingredient:	drospirenone; ethinyl estradiol; levomefolate calcium
Patents:	0

Suppliers and Packaging for NDA: 205947

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM	drospirenone; ethinyl estradiol; levomefolate calcium	TABLET;ORAL	205947	ANDA	Lupin Pharmaceuticals, Inc.	68180-894	68180-894-73	3 POUCH in 1 CARTON (68180-894-73) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	3MG,N/A;0.02MG,N/A;0.451MG,0.451MG
Approval Date:	Jun 13, 2018	TE:	AB	RLD:	No

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