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Serving leading biopharmaceutical companies globally:

UBS
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Baxter
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Fuji
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Teva
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Generated: October 19, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 200384

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NDA 200384 describes NORGESTIMATE AND ETHINYL ESTRADIOL, which is a drug marketed by Watson Labs, Lupin Ltd, Mylan Labs Ltd, Glenmark Generics, Lupin Pharms, Glenmark Pharms, Amneal Pharms, and Oc Pharma, 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-one suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norgestimate profile page.

Summary for NDA: 200384

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 200384

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NORGESTIMATE AND ETHINYL ESTRADIOL
ethinyl estradiol; norgestimate
TABLET;ORAL-28 200384 ANDA Akorn, Inc. 17478-260 17478-260-06 6 CARTON in 1 CARTON (17478-260-06) > 1 BLISTER PACK in 1 CARTON (17478-260-28) > 1 KIT in 1 BLISTER PACK * 21 TABLET in 1 BLISTER PACK * 7 TABLET in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORAL-28Strength0.035MG;0.25MG
Approval Date:Apr 7, 2015TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

McKesson
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