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Last Updated: December 17, 2025

Details for New Drug Application (NDA): 200494


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NDA 200494 describes NORGESTIMATE AND ETHINYL ESTRADIOL, which is a drug marketed by Glenmark Pharms Ltd, Glenmark Speclt, Lupin Ltd, Lupin Pharms, Mylan, Naari Pte, Watson Labs, and Xiromed, and is included in seventeen NDAs. It is available from seven suppliers. Additional details are available on the NORGESTIMATE AND ETHINYL ESTRADIOL profile page.

The generic ingredient in NORGESTIMATE AND ETHINYL ESTRADIOL is ethinyl estradiol; norgestimate. There are twenty-six drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norgestimate profile page.
Summary for 200494
Tradename:NORGESTIMATE AND ETHINYL ESTRADIOL
Applicant:Glenmark Pharms Ltd
Ingredient:ethinyl estradiol; norgestimate
Patents:0
Suppliers and Packaging for NDA: 200494
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NORGESTIMATE AND ETHINYL ESTRADIOL ethinyl estradiol; norgestimate TABLET;ORAL-28 200494 ANDA A-S Medication Solutions 50090-2603 50090-2603-0 1 KIT in 1 KIT (50090-2603-0)
NORGESTIMATE AND ETHINYL ESTRADIOL ethinyl estradiol; norgestimate TABLET;ORAL-28 200494 ANDA Glenmark Pharmaceuticals Inc., USA 68462-565 68462-565-29 3 BLISTER PACK in 1 CARTON (68462-565-29) / 1 KIT in 1 BLISTER PACK (68462-565-84)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORAL-28Strength0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG
Approval Date:Jun 17, 2011TE:ABRLD:No

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Preferred Citation:

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