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Last Updated: July 3, 2020

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Details for New Drug Application (NDA): 020076


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NDA 020076 describes HABITROL, which is a drug marketed by Dr Reddys Labs Sa and is included in one NDA. It is available from eleven suppliers. Additional details are available on the HABITROL profile page.

The generic ingredient in HABITROL is nicotine. There are thirty drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the nicotine profile page.
Summary for 020076
Tradename:HABITROL
Applicant:Dr Reddys Labs Sa
Ingredient:nicotine
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 020076
Suppliers and Packaging for NDA: 020076
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HABITROL nicotine FILM, EXTENDED RELEASE;TRANSDERMAL 020076 NDA Walgreens Company 0363-0451 0363-0451-74 14 PATCH in 1 CARTON (0363-0451-74) > 24 h in 1 PATCH
HABITROL nicotine FILM, EXTENDED RELEASE;TRANSDERMAL 020076 NDA Walgreens Company 0363-0455 0363-0455-70 7 PATCH in 1 CARTON (0363-0455-70) > 24 h in 1 PATCH
Paragraph IV (Patent) Challenges for 020076
Tradename Dosage Ingredient NDA Submissiondate
HABITROL FILM, EXTENDED RELEASE;TRANSDERMAL nicotine 020076

Profile for product number 004

Active Rx/OTC/Discontinued:OTCDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength7MG/24HR
Approval Date:Nov 12, 1999TE:RLD:Yes

Profile for product number 005

Active Rx/OTC/Discontinued:OTCDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength14MG/24HR
Approval Date:Nov 12, 1999TE:RLD:Yes

Profile for product number 006

Active Rx/OTC/Discontinued:OTCDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength21MG/24HR
Approval Date:Nov 12, 1999TE:RLD:Yes

Expired US Patents for NDA 020076

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Dr Reddys Labs Sa HABITROL nicotine FILM, EXTENDED RELEASE;TRANSDERMAL 020076-005 Nov 12, 1999   Start Trial   Start Trial
Dr Reddys Labs Sa HABITROL nicotine FILM, EXTENDED RELEASE;TRANSDERMAL 020076-005 Nov 12, 1999   Start Trial   Start Trial
Dr Reddys Labs Sa HABITROL nicotine FILM, EXTENDED RELEASE;TRANSDERMAL 020076-004 Nov 12, 1999   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

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