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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 Inc and is included in one NDA. It is available from fourteen suppliers. Additional details are available on the HABITROL profile page.

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

Summary for NDA: 020076

Tradename:
HABITROL
Applicant:
Dr Reddys Labs Inc
Ingredient:
nicotine
Patents:0
Therapeutic Class:Antidotes, Deterrents, and Toxicologic Agents
Formulation / Manufacturing:see details

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 Novartis Consumer Health, Inc. 0067-4850 0067-4850-14 14 POUCH in 1 BOX, UNIT-DOSE (0067-4850-14) > 1 PATCH in 1 POUCH > 24 h in 1 PATCH
HABITROL
nicotine
FILM, EXTENDED RELEASE;TRANSDERMAL 020076 NDA Novartis Consumer Health, Inc. 0067-4860 0067-4860-07 7 POUCH in 1 CARTON (0067-4860-07) > 1 PATCH in 1 POUCH > 24 h in 1 PATCH

Summary for product number 004

Active Rx/OTC/Discontinued:OTCDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength7MG/24HR
Approval Date:Nov 12, 1999TE:RLD:No

Summary for product number 005

Active Rx/OTC/Discontinued:OTCDosage:FILM, EXTENDED RELEASE;TRANSDERMALStrength14MG/24HR
Approval Date:Nov 12, 1999TE:RLD:No

Summary for product number 006

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

Expired Orange Book Patents for NDA: 020076

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Dr Reddys Labs Inc
HABITROL
nicotine
FILM, EXTENDED RELEASE;TRANSDERMAL020076-006Nov 12, 19994,597,961► subscribe
Dr Reddys Labs Inc
HABITROL
nicotine
FILM, EXTENDED RELEASE;TRANSDERMAL020076-006Nov 12, 19995,016,652► subscribe
Dr Reddys Labs Inc
HABITROL
nicotine
FILM, EXTENDED RELEASE;TRANSDERMAL020076-004Nov 12, 19994,597,961► subscribe
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