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Generated: September 24, 2018

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Details for New Drug Application (NDA): 200538

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NDA 200538 describes NORGESTIMATE AND ETHINYL ESTRADIOL, which is a drug marketed by Glenmark Generics, Amneal Pharms, Glenmark Pharms, Lupin Ltd, Lupin Pharms, Mylan Labs Ltd, Oc Pharma, and Watson Labs, and is included in seventeen NDAs. It is available from nine 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-five suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norgestimate profile page.
Summary for 200538
Suppliers and Packaging for NDA: 200538
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NORGESTIMATE AND ETHINYL ESTRADIOL ethinyl estradiol; norgestimate TABLET;ORAL-28 200538 ANDA RPK Pharmaceuticals, Inc. 53002-1732 53002-1732-1 1 BLISTER PACK in 1 PACKAGE (53002-1732-1) > 1 KIT in 1 BLISTER PACK
NORGESTIMATE AND ETHINYL ESTRADIOL ethinyl estradiol; norgestimate TABLET;ORAL-28 200538 ANDA RPK Pharmaceuticals, Inc. 53002-1732 53002-1732-3 3 BLISTER PACK in 1 PACKAGE (53002-1732-3) > 1 KIT in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORAL-28Strength0.035MG;0.25MG
Approval Date:Apr 5, 2012TE:ABRLD:No

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