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Details for New Drug Application (NDA): 201887

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NDA 201887 describes ENSKYCE, which is a drug marketed by Lupin Ltd and is included in one NDA. It is available from two suppliers. Additional details are available on the ENSKYCE profile page.

The generic ingredient in ENSKYCE is desogestrel; ethinyl estradiol. There are eight drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the desogestrel; ethinyl estradiol profile page.

Summary for NDA: 201887

Tradename:
ENSKYCE
Applicant:
Lupin Ltd
Ingredient:
desogestrel; ethinyl estradiol
Patents:0
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 201887

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ENSKYCE
desogestrel; ethinyl estradiol
TABLET;ORAL-28 201887 ANDA LUPIN LIMITED 57297-882 57297-882-13 3 POUCH in 1 CARTON (57297-882-13) > 1 BLISTER PACK in 1 POUCH (57297-882-11) > 1 KIT in 1 BLISTER PACK
ENSKYCE
desogestrel; ethinyl estradiol
TABLET;ORAL-28 201887 ANDA Lupin Pharmaceuticals, Inc. 68180-882 68180-882-13 3 POUCH in 1 CARTON (68180-882-13) > 1 BLISTER PACK in 1 POUCH (68180-882-11) > 1 KIT in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORAL-28Strength0.15MG;0.03MG
Approval Date:Mar 7, 2013TE: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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