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 twelve 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-six 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

Pharmacology for NDA: 020076

Medical Subject Heading (MeSH) Categories for 020076

Ganglionic Stimulants
Nicotinic Agonists

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

Profile for product number 004

Active Rx/OTC/Discontinued:	OTC	Dosage:	FILM, EXTENDED RELEASE;TRANSDERMAL			Strength	7MG/24HR
Approval Date:	Nov 12, 1999	TE:		RLD:	Yes

Profile for product number 005

Active Rx/OTC/Discontinued:	OTC	Dosage:	FILM, EXTENDED RELEASE;TRANSDERMAL			Strength	14MG/24HR
Approval Date:	Nov 12, 1999	TE:		RLD:	Yes

Profile for product number 006

Active Rx/OTC/Discontinued:	OTC	Dosage:	FILM, EXTENDED RELEASE;TRANSDERMAL			Strength	21MG/24HR
Approval Date:	Nov 12, 1999	TE:		RLD:	Yes

Expired US Patents for NDA 020076

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

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