U.S. flag An official website of the United States government
  1. Home
  2. Drug Databases
  3. Orange Book Home

Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

Product Details for ANDA 201785

Expand all

VARENICLINE TARTRATE (VARENICLINE TARTRATE)
EQ 0.5MG BASE
Marketing Status: Prescription
Active Ingredient: VARENICLINE TARTRATE
Proprietary Name: VARENICLINE TARTRATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 0.5MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A201785
Product Number: 001
Approval Date: Aug 11, 2021
Applicant Holder Full Name: PAR PHARMACEUTICAL INC
Marketing Status:  Prescription
Patent and Exclusivity Information
VARENICLINE TARTRATE (VARENICLINE TARTRATE)
EQ 1MG BASE
Marketing Status: Prescription
Active Ingredient: VARENICLINE TARTRATE
Proprietary Name: VARENICLINE TARTRATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 1MG BASE
Reference Listed Drug: No
Reference Standard: Yes
TE Code: 
Application Number: A201785
Product Number: 002
Approval Date: Aug 11, 2021
Applicant Holder Full Name: PAR PHARMACEUTICAL INC
Marketing Status:  Prescription
Patent and Exclusivity Information
Back to Top