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Generated: May 24, 2018

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Details for New Drug Application (NDA): 019653

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NDA 019653 describes ORTHO CYCLEN-28, which is a drug marketed by Janssen Pharms and is included in one NDA. It is available from three suppliers. Additional details are available on the ORTHO CYCLEN-28 profile page.

The generic ingredient in ORTHO CYCLEN-28 is ethinyl estradiol; norgestimate. 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; norgestimate profile page.
Summary for 019653
Tradename:ORTHO CYCLEN-28
Applicant:Janssen Pharms
Ingredient:ethinyl estradiol; norgestimate
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 019653
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ORTHO CYCLEN-21 ethinyl estradiol; norgestimate TABLET;ORAL-21 019653 NDA Janssen Pharmaceuticals, Inc. 50458-191 N 50458-191-06
ORTHO CYCLEN-21 ethinyl estradiol; norgestimate TABLET;ORAL-21 019653 NDA Janssen Pharmaceuticals, Inc. 50458-191 N 50458-191-12

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORAL-21Strength0.035MG;0.25MG
Approval Date:Dec 29, 1989TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORAL-28Strength0.035MG;0.25MG
Approval Date:Dec 29, 1989TE:ABRLD:Yes

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