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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 091425


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NDA 091425 describes LEVONORGESTREL AND ETHINYL ESTRADIOL, which is a drug marketed by Amneal Pharms, Glenmark Pharms Ltd, Lupin Ltd, Watson Labs, Xiromed, Barr, Dr Reddys Labs Sa, Hetero Labs, and Naari Pte Ltd, and is included in twenty-nine NDAs. It is available from eleven suppliers. Additional details are available on the LEVONORGESTREL AND ETHINYL ESTRADIOL profile page.

The generic ingredient in LEVONORGESTREL AND ETHINYL ESTRADIOL is ethinyl estradiol; levonorgestrel. There are twenty-six drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; levonorgestrel profile page.
Summary for 091425
Suppliers and Packaging for NDA: 091425
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LEVONORGESTREL AND ETHINYL ESTRADIOL ethinyl estradiol; levonorgestrel TABLET;ORAL-28 091425 ANDA Lupin Pharmaceuticals, Inc. 68180-854 68180-854-73 3 BLISTER PACK in 1 CARTON (68180-854-73) / 1 KIT in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORAL-28Strength0.02MG;0.1MG
Approval Date:Jan 18, 2013TE:AB1RLD:No

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