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Details for New Drug Application (NDA): 091408

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NDA 091408 describes KURVELO, 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 KURVELO profile page.

The generic ingredient in KURVELO is ethinyl estradiol; levonorgestrel. There are twenty-six drug master file entries for this compound. Twenty-five suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the ethinyl estradiol; levonorgestrel profile page.

Summary for NDA: 091408

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

Suppliers and Packaging for NDA: 091408

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
KURVELO
ethinyl estradiol; levonorgestrel
TABLET;ORAL-28 091408 ANDA LUPIN LIMITED 57297-844 57297-844-13 3 BLISTER PACK in 1 CARTON (57297-844-13) > 1 KIT in 1 BLISTER PACK (57297-844-11)
KURVELO
ethinyl estradiol; levonorgestrel
TABLET;ORAL-28 091408 ANDA Lupin Pharmaceuticals, Inc. 68180-844 68180-844-13 3 BLISTER PACK in 1 CARTON (68180-844-13) > 1 KIT in 1 BLISTER PACK (68180-844-11)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORAL-28Strength0.03MG;0.15MG
Approval Date:Oct 17, 2012TE:ABRLD:No


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