Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 073263
Company: UPSHER SMITH LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PREVALITE CHOLESTYRAMINE EQ 4GM RESIN/PACKET POWDER;ORAL Prescription AB No No
PREVALITE 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
02/22/1996 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
12/19/2002 SUPPL-12 Manufacturing (CMC)-Facility

Label is not available on this site.

10/29/1999 SUPPL-11 Manufacturing (CMC)-Facility

Label is not available on this site.

08/27/1999 SUPPL-10 Labeling

Label is not available on this site.

08/27/1999 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

08/27/1999 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

02/20/1998 SUPPL-7 Labeling

Label is not available on this site.

10/30/1997 SUPPL-5 Labeling

Label is not available on this site.

10/30/1997 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

08/21/1996 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

06/24/1996 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

PREVALITE

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 USA INC
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 USA INC
PREVALITE CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER;ORAL Prescription No AB 073263 UPSHER SMITH LABS

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