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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 202594


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NDA 202594 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 202594
Suppliers and Packaging for NDA: 202594
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DROSPIRENONE AND ETHINYL ESTRADIOL drospirenone; ethinyl estradiol TABLET;ORAL 202594 ANDA Mylan Pharmaceuticals Inc. 0378-7299 0378-7299-53 3 POUCH in 1 CARTON (0378-7299-53) / 1 BLISTER PACK in 1 POUCH (0378-7299-85) / 1 KIT in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength3MG;0.02MG
Approval Date:Oct 22, 2015TE:ABRLD:No

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