Last Updated: September 28, 2026

Details for New Drug Application (NDA): 202791


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NDA 202791 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, Hetero Labs, and Lupin, and is included in twenty-nine NDAs. It is available from seven 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 is one drug master file entry for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; levonorgestrel profile page.
Summary for 202791
Tradename:LEVONORGESTREL AND ETHINYL ESTRADIOL
Applicant:Glenmark Pharms Ltd
Ingredient:ethinyl estradiol; levonorgestrel
Patents:0
Pharmacology for NDA: 202791
Mechanism of ActionEstrogen Receptor Agonists
Physiological EffectInhibit Ovum Fertilization
Suppliers and Packaging for NDA: 202791
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LEVONORGESTREL AND ETHINYL ESTRADIOL ethinyl estradiol; levonorgestrel TABLET;ORAL 202791 ANDA Glenmark Pharmaceuticals Inc., USA 68462-637 68462-637-29 3 POUCH in 1 CARTON (68462-637-29) / 1 BLISTER PACK in 1 POUCH (68462-637-84) / 28 TABLET in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.02MG;0.09MG
Approval Date:Apr 9, 2015TE:ABRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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