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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 200541


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NDA 200541 describes NORGESTIMATE AND ETHINYL ESTRADIOL, which is a drug marketed by Amneal Pharms, Glenmark Generics, Glenmark Pharms, Lupin Ltd, Lupin Pharms, Mylan, Mylan Labs Ltd, Naari Pte Ltd, and Watson Labs, and is included in seventeen NDAs. It is available from eight 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. Twenty suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norgestimate profile page.
Summary for 200541
Suppliers and Packaging for NDA: 200541
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NORGESTIMATE AND ETHINYL ESTRADIOL ethinyl estradiol; norgestimate TABLET;ORAL-28 200541 ANDA Proficient Rx LP 63187-754 63187-754-28 1 BLISTER PACK in 1 POUCH (63187-754-28) / 1 KIT in 1 BLISTER PACK
NORGESTIMATE AND ETHINYL ESTRADIOL ethinyl estradiol; norgestimate TABLET;ORAL-28 200541 ANDA Lupin Pharmaceuticals, Inc. 68180-837 68180-837-73 3 POUCH in 1 CARTON (68180-837-73) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORAL-28Strength0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG
Approval Date:Jun 25, 2012TE:ABRLD:No

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