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Generated: September 20, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 017565

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NDA 017565 describes NORINYL 1+35 28-DAY, which is a drug marketed by Allergan Sales Llc and is included in one NDA. It is available from one supplier. Additional details are available on the NORINYL 1+35 28-DAY profile page.

The generic ingredient in NORINYL 1+35 28-DAY is ethinyl estradiol; norethindrone. 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 profile page.

Summary for NDA: 017565

Tradename:
2
Applicant:
1
Ingredient:
1
Patents:0
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 017565

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NORINYL 1+35 21-DAY
ethinyl estradiol; norethindrone
TABLET;ORAL-21 017565 NDA Actavis Pharma, Inc. 52544-259 52544-259-28 6 BLISTER PACK in 1 CARTON (52544-259-28) > 1 KIT in 1 BLISTER PACK
NORINYL 1+35 28-DAY
ethinyl estradiol; norethindrone
TABLET;ORAL-28 017565 NDA Actavis Pharma, Inc. 52544-259 52544-259-28 6 BLISTER PACK in 1 CARTON (52544-259-28) > 1 KIT in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORAL-21Strength0.035MG;1MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORAL-28Strength0.035MG;1MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:No


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Cipla
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