Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074554
Company: ANI PHARMS INC
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
10/02/1996 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/31/2000 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

07/30/1999 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

03/23/1999 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

12/01/1998 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

02/18/1998 SUPPL-2 Labeling

Label is not available on this site.

10/17/1997 SUPPL-1 Manufacturing (CMC)

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 074554 ANI PHARMS INC
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 074557 SANDOZ
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 074558 SANDOZ
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 074554 ANI PHARMS INC
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 074557 SANDOZ
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 077203 PAR PHARM
CHOLESTYRAMINE LIGHT CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER;ORAL Prescription No AB 074558 SANDOZ
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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