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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211119
Company: AJANTA PHARMA LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CHOLESTYRAMINE CHOLESTYRAMINE EQ 4GM RESIN/PACKET POWDER;ORAL Prescription AB No No
CHOLESTYRAMINE CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER;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
04/06/2020 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
09/14/2021 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

CHOLESTYRAMINE

POWDER;ORAL; EQ 4GM RESIN/PACKET
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CHOLESTYRAMINE CHOLESTYRAMINE EQ 4GM RESIN/PACKET POWDER;ORAL Prescription No AB 211119 AJANTA PHARMA LTD
CHOLESTYRAMINE CHOLESTYRAMINE EQ 4GM RESIN/PACKET POWDER;ORAL Prescription No AB 211856 ALKEM LABS LTD
CHOLESTYRAMINE CHOLESTYRAMINE EQ 4GM RESIN/PACKET POWDER;ORAL Prescription No AB 074554 ANI PHARMS
CHOLESTYRAMINE CHOLESTYRAMINE EQ 4GM RESIN/PACKET POWDER;ORAL Prescription No AB 074557 EPIC PHARMA
CHOLESTYRAMINE CHOLESTYRAMINE EQ 4GM RESIN/PACKET POWDER;ORAL Prescription No AB 077204 PAR PHARM
CHOLESTYRAMINE CHOLESTYRAMINE EQ 4GM RESIN/PACKET POWDER;ORAL Prescription No AB 209597 TAGI
CHOLESTYRAMINE LIGHT CHOLESTYRAMINE EQ 4GM RESIN/PACKET POWDER;ORAL Prescription No AB 211799 ALKEM LABS LTD
CHOLESTYRAMINE LIGHT CHOLESTYRAMINE EQ 4GM RESIN/PACKET POWDER;ORAL Prescription No AB 074558 EPIC PHARMA
CHOLESTYRAMINE LIGHT CHOLESTYRAMINE EQ 4GM RESIN/PACKET POWDER;ORAL Prescription No AB 077203 PAR PHARM
CHOLESTYRAMINE LIGHT CHOLESTYRAMINE EQ 4GM RESIN/PACKET POWDER;ORAL Prescription No AB 209599 TAGI
PREVALITE CHOLESTYRAMINE EQ 4GM RESIN/PACKET POWDER;ORAL Prescription No AB 073263 UPSHER SMITH LABS

POWDER;ORAL; EQ 4GM RESIN/SCOOPFUL
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CHOLESTYRAMINE CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER;ORAL Prescription No AB 211119 AJANTA PHARMA LTD
CHOLESTYRAMINE CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER;ORAL Prescription No AB 211856 ALKEM LABS LTD
CHOLESTYRAMINE CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER;ORAL Prescription No AB 074554 ANI PHARMS
CHOLESTYRAMINE CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER;ORAL Prescription No AB 074557 EPIC PHARMA
CHOLESTYRAMINE CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER;ORAL Prescription No AB 077204 PAR PHARM
CHOLESTYRAMINE CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER;ORAL Prescription No AB 209597 TAGI
CHOLESTYRAMINE CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER;ORAL Prescription No AB 202901 ZYDUS PHARMS
CHOLESTYRAMINE LIGHT CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER;ORAL Prescription No AB 211799 ALKEM LABS LTD
CHOLESTYRAMINE LIGHT CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER;ORAL Prescription No AB 074558 EPIC PHARMA
CHOLESTYRAMINE LIGHT CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER;ORAL Prescription No AB 077203 PAR PHARM
CHOLESTYRAMINE LIGHT CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER;ORAL Prescription No AB 209599 TAGI
CHOLESTYRAMINE LIGHT CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER;ORAL Prescription No AB 202902 ZYDUS PHARMS
PREVALITE CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER;ORAL Prescription No AB 073263 UPSHER SMITH LABS
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