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Details for New Drug Application (NDA): 019697

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NDA 019697 describes ORTHO TRI-CYCLEN, which is a drug marketed by Janssen Pharms and is included in two NDAs. It is available from two suppliers. There is one patent protecting this drug. Additional details are available on the ORTHO TRI-CYCLEN profile page.

The generic ingredient in ORTHO TRI-CYCLEN is ethinyl estradiol; norgestimate. 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; norgestimate profile page.

Summary for NDA: 019697

Tradename:
ORTHO TRI-CYCLEN
Applicant:
Janssen Pharms
Ingredient:
ethinyl estradiol; norgestimate
Patents:0
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 019697

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ORTHO TRI-CYCLEN
ethinyl estradiol; norgestimate
TABLET;ORAL-21 019697 NDA Rebel Distributors Corp 21695-407 21695-407-01 6 DIALPACK in 1 CARTON (21695-407-01) > 1 KIT in 1 DIALPACK
ORTHO TRI-CYCLEN
ethinyl estradiol; norgestimate
TABLET;ORAL-21 019697 NDA Physicians Total Care, Inc. 54868-5826 54868-5826-0 1 DIALPACK in 1 CARTON (54868-5826-0) > 1 KIT in 1 DIALPACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORAL-28Strength0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG
Approval Date:Jul 3, 1992TE:ABRLD:Yes

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORAL-21Strength0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG
Approval Date:Jul 3, 1992TE:RLD:No

Expired Orange Book Patents for NDA: 019697

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms
ORTHO TRI-CYCLEN
ethinyl estradiol; norgestimate
TABLET;ORAL-21019697-002Jul 3, 19924,027,019► subscribe
Janssen Pharms
ORTHO TRI-CYCLEN
ethinyl estradiol; norgestimate
TABLET;ORAL-21019697-002Jul 3, 19924,628,051► subscribe
Janssen Pharms
ORTHO TRI-CYCLEN
ethinyl estradiol; norgestimate
TABLET;ORAL-28019697-001Jul 3, 19924,628,051*PED► subscribe
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