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Details for New Drug Application (NDA): 201886

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NDA 201886 describes VYFEMLA, 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 VYFEMLA profile page.

The generic ingredient in VYFEMLA is ethinyl estradiol; norethindrone. There are twenty-six drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone profile page.

Summary for NDA: 201886

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

Suppliers and Packaging for NDA: 201886

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VYFEMLA
ethinyl estradiol; norethindrone
TABLET;ORAL-28 201886 ANDA LUPIN LIMITED 57297-875 57297-875-13 3 POUCH in 1 CARTON (57297-875-13) > 1 BLISTER PACK in 1 POUCH (57297-875-11) > 1 KIT in 1 BLISTER PACK
VYFEMLA
ethinyl estradiol; norethindrone
TABLET;ORAL-28 201886 ANDA Lupin Pharmaceuticals, Inc. 68180-875 68180-875-13 3 POUCH in 1 CARTON (68180-875-13) > 1 BLISTER PACK in 1 POUCH (68180-875-11) > 1 KIT in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORAL-28Strength0.035MG;0.4MG
Approval Date:Sep 26, 2013TE:ABRLD:No


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