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Abbreviated New Drug Application (ANDA): 201785
Company: PH HEALTH

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 Yes

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
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/23/2024 SUPPL-5 Labeling-Package Insert, Labeling-Medication Guide, Labeling-Container/Carton Labels

Label is not available on this site.

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 213019 AJANTA PHARMA LTD
VARENICLINE TARTRATE VARENICLINE TARTRATE EQ 0.5MG BASE TABLET;ORAL Prescription No AB 214557 ALKEM LABS LTD
VARENICLINE TARTRATE VARENICLINE TARTRATE EQ 0.5MG BASE TABLET;ORAL Prescription No AB 201962 APOTEX
VARENICLINE TARTRATE VARENICLINE TARTRATE EQ 0.5MG BASE TABLET;ORAL Prescription No AB 214595 AUROBINDO PHARMA
VARENICLINE TARTRATE VARENICLINE TARTRATE EQ 0.5MG BASE TABLET;ORAL Prescription No AB 215931 DR REDDYS
VARENICLINE TARTRATE VARENICLINE TARTRATE EQ 0.5MG BASE TABLET;ORAL Prescription No AB 214571 HETERO LABS LTD III
VARENICLINE TARTRATE VARENICLINE TARTRATE EQ 0.5MG BASE TABLET;ORAL Prescription No AB 217151 KANCHAN HLTHCARE
VARENICLINE TARTRATE VARENICLINE TARTRATE EQ 0.5MG BASE TABLET;ORAL Prescription No AB 211862 LUPIN LTD
VARENICLINE TARTRATE VARENICLINE TARTRATE EQ 0.5MG BASE TABLET;ORAL Prescription No AB 215048 MACLEODS PHARMS LTD
VARENICLINE TARTRATE VARENICLINE TARTRATE EQ 0.5MG BASE TABLET;ORAL Prescription No AB 214255 MANKIND PHARMA
VARENICLINE TARTRATE VARENICLINE TARTRATE EQ 0.5MG BASE TABLET;ORAL Prescription No AB 218302 MICRO LABS
VARENICLINE TARTRATE VARENICLINE TARTRATE EQ 0.5MG BASE TABLET;ORAL Prescription No AB 217283 NE RX PHARMA
VARENICLINE TARTRATE VARENICLINE TARTRATE EQ 0.5MG BASE TABLET;ORAL Prescription No AB 201785 PH HEALTH
VARENICLINE TARTRATE VARENICLINE TARTRATE EQ 0.5MG BASE TABLET;ORAL Prescription No AB 202019 PHARMOBEDIENT
VARENICLINE TARTRATE VARENICLINE TARTRATE EQ 0.5MG BASE TABLET;ORAL Prescription No AB 217115 PIRAMAL
VARENICLINE TARTRATE VARENICLINE TARTRATE EQ 0.5MG BASE TABLET;ORAL Prescription No AB 219106 REGCON HOLDINGS
VARENICLINE TARTRATE VARENICLINE TARTRATE EQ 0.5MG BASE TABLET;ORAL Prescription No AB 216615 SHILPA
VARENICLINE TARTRATE VARENICLINE TARTRATE EQ 0.5MG BASE TABLET;ORAL Prescription No AB 218985 UMEDICA
VARENICLINE TARTRATE VARENICLINE TARTRATE EQ 0.5MG BASE TABLET;ORAL Prescription No AB 212879 VIWIT PHARM
VARENICLINE TARTRATE VARENICLINE TARTRATE EQ 0.5MG BASE TABLET;ORAL Prescription No AB 216723 ZYDUS

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 213019 AJANTA PHARMA LTD
VARENICLINE TARTRATE VARENICLINE TARTRATE EQ 1MG BASE TABLET;ORAL Prescription No AB 214557 ALKEM LABS LTD
VARENICLINE TARTRATE VARENICLINE TARTRATE EQ 1MG BASE TABLET;ORAL Prescription No AB 201962 APOTEX
VARENICLINE TARTRATE VARENICLINE TARTRATE EQ 1MG BASE TABLET;ORAL Prescription No AB 214595 AUROBINDO PHARMA
VARENICLINE TARTRATE VARENICLINE TARTRATE EQ 1MG BASE TABLET;ORAL Prescription No AB 215931 DR REDDYS
VARENICLINE TARTRATE VARENICLINE TARTRATE EQ 1MG BASE TABLET;ORAL Prescription No AB 214571 HETERO LABS LTD III
VARENICLINE TARTRATE VARENICLINE TARTRATE EQ 1MG BASE TABLET;ORAL Prescription No AB 217151 KANCHAN HLTHCARE
VARENICLINE TARTRATE VARENICLINE TARTRATE EQ 1MG BASE TABLET;ORAL Prescription No AB 211862 LUPIN LTD
VARENICLINE TARTRATE VARENICLINE TARTRATE EQ 1MG BASE TABLET;ORAL Prescription No AB 215048 MACLEODS PHARMS LTD
VARENICLINE TARTRATE VARENICLINE TARTRATE EQ 1MG BASE TABLET;ORAL Prescription No AB 214255 MANKIND PHARMA
VARENICLINE TARTRATE VARENICLINE TARTRATE EQ 1MG BASE TABLET;ORAL Prescription No AB 218302 MICRO LABS
VARENICLINE TARTRATE VARENICLINE TARTRATE EQ 1MG BASE TABLET;ORAL Prescription No AB 217283 NE RX PHARMA
VARENICLINE TARTRATE VARENICLINE TARTRATE EQ 1MG BASE TABLET;ORAL Prescription No AB 201785 PH HEALTH
VARENICLINE TARTRATE VARENICLINE TARTRATE EQ 1MG BASE TABLET;ORAL Prescription No AB 202019 PHARMOBEDIENT
VARENICLINE TARTRATE VARENICLINE TARTRATE EQ 1MG BASE TABLET;ORAL Prescription No AB 217115 PIRAMAL
VARENICLINE TARTRATE VARENICLINE TARTRATE EQ 1MG BASE TABLET;ORAL Prescription No AB 219106 REGCON HOLDINGS
VARENICLINE TARTRATE VARENICLINE TARTRATE EQ 1MG BASE TABLET;ORAL Prescription No AB 216615 SHILPA
VARENICLINE TARTRATE VARENICLINE TARTRATE EQ 1MG BASE TABLET;ORAL Prescription No AB 218985 UMEDICA
VARENICLINE TARTRATE VARENICLINE TARTRATE EQ 1MG BASE TABLET;ORAL Prescription No AB 212879 VIWIT PHARM
VARENICLINE TARTRATE VARENICLINE TARTRATE EQ 1MG BASE TABLET;ORAL Prescription No AB 216723 ZYDUS
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