Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 201785
Company: PAR PHARM INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VARENICLINE TARTRATE VARENICLINE TARTRATE EQ 0.5MG BASE TABLET;ORAL Prescription AB No No
VARENICLINE TARTRATE VARENICLINE TARTRATE EQ 1MG BASE TABLET;ORAL Prescription AB No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
08/11/2021 ORIG-1 Approval Not Applicable Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/201785Orig1s000ltr.pdf

VARENICLINE TARTRATE

TABLET;ORAL; EQ 0.5MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CHANTIX VARENICLINE TARTRATE EQ 0.5MG BASE TABLET;ORAL Prescription Yes AB 021928 PF PRISM CV
VARENICLINE TARTRATE VARENICLINE TARTRATE EQ 0.5MG BASE TABLET;ORAL Prescription No AB 201785 PAR PHARM INC

TABLET;ORAL; EQ 1MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CHANTIX VARENICLINE TARTRATE EQ 1MG BASE TABLET;ORAL Prescription Yes AB 021928 PF PRISM CV
VARENICLINE TARTRATE VARENICLINE TARTRATE EQ 1MG BASE TABLET;ORAL Prescription No AB 201785 PAR PHARM INC

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