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Last Updated: December 13, 2025

Details for New Drug Application (NDA): 200490


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NDA 200490 describes LEVONORGESTREL AND ETHINYL ESTRADIOL, which is a drug marketed by Glenmark Pharms Ltd, Lupin Ltd, Naari Pte, Watson Labs, Xiromed, Barr, Amneal Pharms, Dr Reddys Labs Sa, and Hetero Labs, and is included in twenty-nine NDAs. It is available from eight 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-three suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; levonorgestrel profile page.
Summary for 200490
Tradename:LEVONORGESTREL AND ETHINYL ESTRADIOL
Applicant:Xiromed
Ingredient:ethinyl estradiol; levonorgestrel
Patents:0
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
LEVONORGESTREL AND ETHINYL ESTRADIOL ethinyl estradiol; levonorgestrel TABLET;ORAL 200490 ANDA Xiromed LLC 70700-208 70700-208-88 3 POUCH in 1 CARTON (70700-208-88) / 1 BLISTER PACK in 1 POUCH (70700-208-87) / 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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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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