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Generated: January 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077681

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NDA 077681 describes LEVONORGESTREL AND ETHINYL ESTRADIOL, which is a drug marketed by Amneal Pharms, Glenmark Generics, Glenmark Pharms Ltd, Lupin Ltd, Mayne Pharma, Mylan Labs Ltd, Watson Labs, and Barr, and is included in twenty-three NDAs. It is available from twelve suppliers. Additional details are available on the LEVONORGESTREL AND ETHINYL ESTRADIOL profile page.

The generic ingredient in LEVONORGESTREL AND ETHINYL ESTRADIOL 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 077681
Tradename:LEVONORGESTREL AND ETHINYL ESTRADIOL
Applicant:Mayne Pharma
Ingredient:ethinyl estradiol; levonorgestrel
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 077681
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LEVONORGESTREL AND ETHINYL ESTRADIOL ethinyl estradiol; levonorgestrel TABLET;ORAL-28 077681 ANDA Mayne Pharma Inc. 51862-545 51862-545-06 6 BLISTER PACK in 1 CARTON (51862-545-06) > 1 KIT in 1 BLISTER PACK (51862-545-01)
LEVONORGESTREL AND ETHINYL ESTRADIOL ethinyl estradiol; levonorgestrel TABLET;ORAL-28 077681 ANDA Watson Pharma, Inc. 52544-967 52544-967-28 6 BLISTER PACK in 1 CARTON (52544-967-28) > 1 KIT in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORAL-28Strength0.02MG;0.1MG
Approval Date:May 31, 2006TE:AB2RLD:No

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