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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211289
Company: VKT PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET;ORAL Prescription AB No No
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 300MG 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
01/31/2019 ORIG-1 Approval STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/07/2019 SUPPL-1 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

RANITIDINE HYDROCHLORIDE

TABLET;ORAL; EQ 150MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET;ORAL Prescription No AB 074680 APOTEX
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET;ORAL Prescription No AB 076705 DR REDDYS LABS INC
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET;ORAL Prescription No AB 078542 GLENMARK PHARMS INC
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET;ORAL Prescription No AB 075180 PAR PHARM
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET;ORAL Prescription No AB 074467 SANDOZ
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 150MG BASE TABLET;ORAL Prescription No AB 211289 VKT PHARMA

TABLET;ORAL; EQ 300MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET;ORAL Prescription No AB 074680 APOTEX
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET;ORAL Prescription No AB 076705 DR REDDYS LABS INC
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET;ORAL Prescription No AB 078542 GLENMARK PHARMS INC
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET;ORAL Prescription No AB 075180 PAR PHARM
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET;ORAL Prescription No AB 074467 SANDOZ
RANITIDINE HYDROCHLORIDE RANITIDINE HYDROCHLORIDE EQ 300MG BASE TABLET;ORAL Prescription No AB 211289 VKT PHARMA
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