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Generated: November 20, 2017

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Details for New Drug Application (NDA): 091090

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NDA 091090 describes NORETHINDRONE ACETATE, which is a drug marketed by Aurobindo Pharma Ltd, Barr, Amneal Pharms, Mylan Labs Ltd, Glenmark Generics, Barr Labs Inc, Mayne Pharma, and Glenmark Pharms Ltd, 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-three suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone acetate profile page.

Summary for 091090

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: 091090

Ingredient-typeProgesterone Congeners

Suppliers and Packaging for NDA: 091090

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NORETHINDRONE ACETATE
norethindrone acetate
TABLET;ORAL 091090 ANDA KAISER FOUNDATION HOSPITALS 0179-0227 0179-0227-70 30 TABLET in 1 BOX, UNIT-DOSE (0179-0227-70)
NORETHINDRONE ACETATE
norethindrone acetate
TABLET;ORAL 091090 ANDA KAISER FOUNDATION HOSPITALS 0179-0227 0179-0227-88 2400 TABLET in 1 BOTTLE (0179-0227-88)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Jul 21, 2010TE:ABRLD:No


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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