Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020076

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HABITROL (NICOTINE)
7MG/24HR
Marketing Status: Over-the-counter

Active Ingredient: NICOTINE
Proprietary Name: HABITROL
Dosage Form; Route of Administration: FILM, EXTENDED RELEASE; TRANSDERMAL
Strength: 7MG/24HR
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N020076
Product Number: 004
Approval Date: Nov 12, 1999
Applicant Holder Full Name: DR REDDYS LABORATORIES SA
Marketing Status:  Over-the-counter
Patent and Exclusivity Information

HABITROL (NICOTINE)
14MG/24HR
Marketing Status: Over-the-counter

Active Ingredient: NICOTINE
Proprietary Name: HABITROL
Dosage Form; Route of Administration: FILM, EXTENDED RELEASE; TRANSDERMAL
Strength: 14MG/24HR
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N020076
Product Number: 005
Approval Date: Nov 12, 1999
Applicant Holder Full Name: DR REDDYS LABORATORIES SA
Marketing Status:  Over-the-counter
Patent and Exclusivity Information

HABITROL (NICOTINE)
21MG/24HR
Marketing Status: Over-the-counter

Active Ingredient: NICOTINE
Proprietary Name: HABITROL
Dosage Form; Route of Administration: FILM, EXTENDED RELEASE; TRANSDERMAL
Strength: 21MG/24HR
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N020076
Product Number: 006
Approval Date: Nov 12, 1999
Applicant Holder Full Name: DR REDDYS LABORATORIES SA
Marketing Status:  Over-the-counter
Patent and Exclusivity Information