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Details for New Drug Application (NDA): 091467

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NDA 091467 describes DAYSEE, which is a drug marketed by Lupin Ltd and is included in one NDA. It is available from one supplier. Additional details are available on the DAYSEE profile page.

The generic ingredient in DAYSEE is ethinyl estradiol; levonorgestrel. There are twenty-six drug master file entries for this compound. Twenty-four 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: 091467

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

Suppliers and Packaging for NDA: 091467

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DAYSEE
ethinyl estradiol; levonorgestrel
TABLET;ORAL 091467 ANDA Lupin Pharmaceuticals, Inc. 68180-846 68180-846-13 2 POUCH in 1 CARTON (68180-846-13) > 1 BLISTER PACK in 1 POUCH (68180-846-11) > 1 KIT in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.03MG,0.01MG;0.15MG,N/A
Approval Date:Apr 10, 2013TE:ABRLD:No


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