drospirenone, ethinyl estradiol and levomefolate calcium and levomefolate calcium

FDA Drug Profile — drospirenone, ethinyl estradiol and levomefolate calcium and levomefolate calcium

Drug Details

Generic Name
drospirenone, ethinyl estradiol and levomefolate calcium and levomefolate calcium
Brand Names
drospirenone, ethinyl estradiol and levomefolate calcium and levomefolate calcium
Application Number
ANDA205947
Sponsor
Lupin Pharmaceuticals, Inc.
NDC Codes
1
Dosage Forms
KIT
Routes
N/A
Active Ingredients
N/A

Indications and Usage

1 INDICATIONS AND USAGE Tydemy is a combination of drospirenone, a progestin and ethinyl estradiol, an estrogen containing a folate, indicated for use by females of reproductive potential to: Prevent pregnancy. ( 1.1 ) Raise folate levels in females of reproductive potential who choose to use an oral contraceptive for contraception. ( 1.2 ) 1.1 Oral Contraceptive Tydemy TM is indicated for use by females of reproductive potential to prevent pregnancy. 1.2 Folate Supplementation Tydemy is indicated in females of reproductive potential who choose to use an oral contraceptive as their method of contraception, to raise folate levels for the purpose of reducing the risk of a neural tube defect in a pregnancy conceived while taking the product or shortly after discontinuing the product.