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Last Updated: November 25, 2024

Details for New Drug Application (NDA): 200490


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NDA 200490 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 200490
Suppliers and Packaging for NDA: 200490
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LEVONORGESTREL AND ETHINYL ESTRADIOL ethinyl estradiol; levonorgestrel TABLET;ORAL 200490 ANDA Mylan Pharmaceuticals Inc. 0378-7281 0378-7281-53 3 POUCH in 1 CARTON (0378-7281-53) / 1 BLISTER PACK in 1 POUCH (0378-7281-85) / 1 KIT in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.03MG;0.15MG
Approval Date:Apr 21, 2015TE:ABRLD:No

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