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Generated: December 15, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204236

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NDA 204236 describes NORETHINDRONE ACETATE, which is a drug marketed by Amneal Pharms, Aurobindo Pharma Ltd, Barr, Glenmark Generics, Mylan Labs Ltd, Barr Labs Inc, Glenmark Pharms Ltd, and Mayne Pharma, and is included in twenty-one NDAs. It is available from nine suppliers. Additional details are available on the NORETHINDRONE ACETATE profile page.

The generic ingredient in NORETHINDRONE ACETATE is ethinyl estradiol; norethindrone acetate. There are twenty-six drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone acetate profile page.

Summary for 204236

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details

Pharmacology for NDA: 204236

Ingredient-typeProgesterone Congeners

Suppliers and Packaging for NDA: 204236

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NORETHINDRONE ACETATE norethindrone acetate TABLET;ORAL 204236 ANDA Aurobindo Pharma Limited 65862-715 65862-715-50 50 TABLET in 1 BOTTLE (65862-715-50)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Jan 8, 2016TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

Fuji
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McKinsey
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Healthtrust
Colorcon
Covington
Queensland Health

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