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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 sixteen 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-two 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. 0067-4920 0067-4920-14 14 POUCH in 1 CARTON (0067-4920-14) > 1 PATCH, EXTENDED RELEASE in 1 POUCH
HABITROL
nicotine
FILM, EXTENDED RELEASE;TRANSDERMAL 020076 NDA Novartis Consumer Health 0067-4970 0067-4970-14 14 POUCH in 1 CARTON (0067-4970-14) > 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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Dr Reddys Labs Inc
HABITROL
nicotine
FILM, EXTENDED RELEASE;TRANSDERMAL020076-004Nov 12, 19994,597,961► subscribe
Dr Reddys Labs Inc
HABITROL
nicotine
FILM, EXTENDED RELEASE;TRANSDERMAL020076-005Nov 12, 19994,597,961► subscribe
Dr Reddys Labs Inc
HABITROL
nicotine
FILM, EXTENDED RELEASE;TRANSDERMAL020076-006Nov 12, 19995,834,011► subscribe
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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