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Generated: November 23, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077502

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NDA 077502 describes MYZILRA, which is a drug marketed by Vintage Pharms Llc and is included in one NDA. It is available from two suppliers. Additional details are available on the MYZILRA profile page.

The generic ingredient in MYZILRA 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 077502

Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 077502

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ethinyl estradiol; levonorgestrel
TABLET;ORAL-28 077502 ANDA Par Pharmaceutical 0603-7625 0603-7625-17 6 BLISTER PACK in 1 CARTON (0603-7625-17) > 1 KIT in 1 BLISTER PACK (0603-7625-01)
ethinyl estradiol; levonorgestrel
TABLET;ORAL-28 077502 ANDA Par Pharmaceutical 0603-7625 0603-7625-49 3 BLISTER PACK in 1 CARTON (0603-7625-49) > 1 KIT in 1 BLISTER PACK (0603-7625-01)

Summary 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:Nov 23, 2011TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Harvard Business School
Federal Trade Commission
Argus Health
Chinese Patent Office

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