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Details for New Drug Application (NDA): 020897

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NDA 020897 describes DITROPAN XL, which is a drug marketed by Janssen Pharms and is included in one NDA. It is available from five suppliers. There are four patents protecting this drug. Additional details are available on the DITROPAN XL profile page.

The generic ingredient in DITROPAN XL is oxybutynin chloride. There are sixteen drug master file entries for this compound. Forty-six suppliers are listed for this compound. Additional details are available on the oxybutynin chloride profile page.

Summary for NDA: 020897

Tradename:
DITROPAN XL
Applicant:
Janssen Pharms
Ingredient:
oxybutynin chloride
Patents:4
Therapeutic Class:Genitourinary Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 020897

Suppliers and Packaging for NDA: 020897

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DITROPAN XL
oxybutynin chloride
TABLET, EXTENDED RELEASE;ORAL 020897 NDA Mylan Pharmaceuticals Inc. 0378-6015 0378-6015-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0378-6015-01)
DITROPAN XL
oxybutynin chloride
TABLET, EXTENDED RELEASE;ORAL 020897 NDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-7521 0615-7521-39 30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (0615-7521-39)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength5MG
Approval Date:Dec 16, 1998TE:ABRLD:No
Patent:5,674,895*PEDPatent Expiration:Nov 22, 2015Product Flag?Substance Flag?Delist Request?
Patent:5,840,754*PEDPatent Expiration:Nov 22, 2015Product Flag?Substance Flag?Delist Request?
Patent:5,912,268*PEDPatent Expiration:Nov 22, 2015Product Flag?Substance Flag?Delist Request?

Expired Orange Book Patents for NDA: 020897

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms
DITROPAN XL
oxybutynin chloride
TABLET, EXTENDED RELEASE;ORAL020897-003Jun 22, 19995,840,754*PED► subscribe
Janssen Pharms
DITROPAN XL
oxybutynin chloride
TABLET, EXTENDED RELEASE;ORAL020897-001Dec 16, 19986,919,092*PED► subscribe
Janssen Pharms
DITROPAN XL
oxybutynin chloride
TABLET, EXTENDED RELEASE;ORAL020897-001Dec 16, 1998783,337► subscribe
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