Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021330

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NICORETTE (NICOTINE POLACRILEX)
EQ 2MG BASE
Marketing Status: Over-the-counter

Active Ingredient: NICOTINE POLACRILEX
Proprietary Name: NICORETTE
Dosage Form; Route of Administration: TROCHE/LOZENGE; ORAL
Strength: EQ 2MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021330
Product Number: 001
Approval Date: Oct 31, 2002
Applicant Holder Full Name: HALEON US HOLDINGS LLC
Marketing Status:  Over-the-counter
Patent and Exclusivity Information

NICORETTE (NICOTINE POLACRILEX)
EQ 4MG BASE
Marketing Status: Over-the-counter

Active Ingredient: NICOTINE POLACRILEX
Proprietary Name: NICORETTE
Dosage Form; Route of Administration: TROCHE/LOZENGE; ORAL
Strength: EQ 4MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N021330
Product Number: 002
Approval Date: Oct 31, 2002
Applicant Holder Full Name: HALEON US HOLDINGS LLC
Marketing Status:  Over-the-counter
Patent and Exclusivity Information