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Last Updated: March 19, 2024

Details for New Drug Application (NDA): 090719


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NDA 090719 describes LEVONEST, which is a drug marketed by Novast Labs Ltd and is included in one NDA. It is available from two suppliers. Additional details are available on the LEVONEST profile page.

The generic ingredient in LEVONEST is ethinyl estradiol; levonorgestrel. There are twenty-six drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; levonorgestrel profile page.
Summary for 090719
Tradename:LEVONEST
Applicant:Novast Labs Ltd
Ingredient:ethinyl estradiol; levonorgestrel
Patents:0
Suppliers and Packaging for NDA: 090719
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LEVONEST ethinyl estradiol; levonorgestrel TABLET;ORAL-28 090719 ANDA Northstar Rx LLC 16714-340 16714-340-01 1 BLISTER PACK in 1 PACKET (16714-340-01) / 1 KIT in 1 BLISTER PACK
LEVONEST ethinyl estradiol; levonorgestrel TABLET;ORAL-28 090719 ANDA Northstar Rx LLC 16714-340 16714-340-02 1 BLISTER PACK in 1 CARTON (16714-340-02) / 1 KIT in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORAL-28Strength0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG
Approval Date:Dec 29, 2010TE:ABRLD:No

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