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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 nineteen 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-one suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone acetate profile page.

Summary for NDA: 091090

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
TABLET;ORAL 091090 ANDA KAISER FOUNDATION HOSPITALS 0179-0227 0179-0227-70 30 TABLET in 1 BOX, UNIT-DOSE (0179-0227-70)
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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