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Last Updated: December 13, 2025

Details for New Drug Application (NDA): 200492


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NDA 200492 describes LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL, which is a drug marketed by Dr Reddys Labs Sa, Lupin Ltd, and Xiromed, and is included in seven NDAs. It is available from five suppliers. Additional details are available on the LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL profile page.

The generic ingredient in LEVONORGESTREL AND ETHINYL ESTRADIOL 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 200492
Tradename:LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL
Applicant:Xiromed
Ingredient:ethinyl estradiol; levonorgestrel
Patents:0
Suppliers and Packaging for NDA: 200492
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL ethinyl estradiol; levonorgestrel TABLET;ORAL 200492 ANDA Mylan Pharmaceuticals Inc. 0378-7285 0378-7285-90 2 POUCH in 1 CARTON (0378-7285-90) / 1 BLISTER PACK in 1 POUCH (0378-7285-85) / 1 KIT in 1 BLISTER PACK
LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL ethinyl estradiol; levonorgestrel TABLET;ORAL 200492 ANDA Xiromed LLC 70700-206 70700-206-93 2 POUCH in 1 CARTON (70700-206-93) / 1 BLISTER PACK in 1 POUCH (70700-206-87) / 1 KIT in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.03MG,0.01MG;0.15MG,N/A
Approval Date:May 27, 2015TE:ABRLD:No

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Preferred Citation:

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