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Last Updated: March 19, 2024

Details for New Drug Application (NDA): 204848


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NDA 204848 describes DROSPIRENONE AND ETHINYL ESTRADIOL, which is a drug marketed by Barr, Glenmark Pharms Ltd, Hetero Labs, Hlthcare, Jubilant Cadista, Mylan Labs Ltd, Watson Labs, 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. Fifteen suppliers are listed for this compound. Additional details are available on the drospirenone; ethinyl estradiol profile page.
Summary for 204848
Suppliers and Packaging for NDA: 204848
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DROSPIRENONE AND ETHINYL ESTRADIOL drospirenone; ethinyl estradiol TABLET;ORAL-28 204848 ANDA A-S Medication Solutions 50090-2494 50090-2494-0 1 KIT in 1 KIT (50090-2494-0)
DROSPIRENONE AND ETHINYL ESTRADIOL drospirenone; ethinyl estradiol TABLET;ORAL-28 204848 ANDA Glenmark Pharmaceuticals Inc., USA 68462-733 68462-733-29 3 BLISTER PACK in 1 CARTON (68462-733-29) / 1 KIT in 1 BLISTER PACK (68462-733-84)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORAL-28Strength3MG;0.03MG
Approval Date:Mar 25, 2016TE:ABRLD:No

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