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Generated: September 21, 2017

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Details for New Drug Application (NDA): 200541

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NDA 200541 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, Haupt Pharma, and Oc Pharma, 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. Twenty-one suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norgestimate profile page.

Summary for NDA: 200541

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

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 LUPIN LIMITED 57297-837 57297-837-13 3 POUCH in 1 CARTON (57297-837-13) > 1 BLISTER PACK in 1 POUCH (57297-837-11) > 1 KIT in 1 BLISTER PACK
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

Summary 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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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