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Details for New Drug Application (NDA): 020575

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NDA 020575 describes DENTIPATCH, which is a drug marketed by Noven and is included in one NDA. Additional details are available on the DENTIPATCH profile page.

The generic ingredient in DENTIPATCH is lidocaine. There are twenty-nine drug master file entries for this compound. Thirty-nine suppliers are listed for this compound. Additional details are available on the lidocaine profile page.

Summary for NDA: 020575

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

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:FILM, EXTENDED RELEASE;BUCCALStrength23MG/PATCH
Approval Date:May 21, 1996TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:PATCH;TOPICALStrength46.1MG/PATCH
Approval Date:May 21, 1996TE:RLD:No

Expired Orange Book Patents for NDA: 020575

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Noven
DENTIPATCH
lidocaine
FILM, EXTENDED RELEASE;BUCCAL020575-001May 21, 19965,234,957► Subscribe
Noven
DENTIPATCH
lidocaine
PATCH;TOPICAL020575-002May 21, 19965,446,070► Subscribe
Noven
DENTIPATCH
lidocaine
FILM, EXTENDED RELEASE;BUCCAL020575-001May 21, 19965,332,576► Subscribe
Noven
DENTIPATCH
lidocaine
PATCH;TOPICAL020575-002May 21, 19965,332,576► Subscribe
Noven
DENTIPATCH
lidocaine
PATCH;TOPICAL020575-002May 21, 19965,234,957► Subscribe
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