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Generated: May 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 201095

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NDA 201095 describes LEVONORGESTREL AND ETHINYL ESTRADIOL, which is a drug marketed by Amneal Pharms, Glenmark Generics, Glenmark Pharms Ltd, Lupin Ltd, Mylan Labs Ltd, Watson Labs, Barr, Mayne Pharma, and Labs Leon Farma, and is included in twenty-five 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-eight suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; levonorgestrel profile page.
Summary for 201095
Tradename:LEVONORGESTREL AND ETHINYL ESTRADIOL
Applicant:Amneal Pharms
Ingredient:ethinyl estradiol; levonorgestrel
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 201095
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LEVONORGESTREL AND ETHINYL ESTRADIOL ethinyl estradiol; levonorgestrel TABLET;ORAL-28 201095 ANDA Amneal Pharmaceuticals LLC 60219-1554 N 60219-1554-6
LEVONORGESTREL AND ETHINYL ESTRADIOL ethinyl estradiol; levonorgestrel TABLET;ORAL-28 201095 ANDA Amneal Pharmaceuticals LLC 69238-1554 N 69238-1554-6

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORAL-28Strength0.03MG;0.15MG
Approval Date:Dec 8, 2014TE:ABRLD:No

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