Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 077277
Company: IMPAX LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
COLESTIPOL HYDROCHLORIDE COLESTIPOL HYDROCHLORIDE 5GM/SCOOPFUL GRANULE;ORAL Prescription AB No No
COLESTIPOL HYDROCHLORIDE COLESTIPOL HYDROCHLORIDE 5GM/PACKET GRANULE;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
05/02/2006 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077277LTR.pdf

COLESTIPOL HYDROCHLORIDE

GRANULE;ORAL; 5GM/SCOOPFUL
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
COLESTID COLESTIPOL HYDROCHLORIDE 5GM/SCOOPFUL GRANULE;ORAL Prescription Yes AB 017563 PHARMACIA UPJOHN
COLESTIPOL HYDROCHLORIDE COLESTIPOL HYDROCHLORIDE 5GM/SCOOPFUL GRANULE;ORAL Prescription No AB 077277 IMPAX LABS

GRANULE;ORAL; 5GM/PACKET
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
COLESTID COLESTIPOL HYDROCHLORIDE 5GM/PACKET GRANULE;ORAL Prescription Yes AB 017563 PHARMACIA UPJOHN
COLESTIPOL HYDROCHLORIDE COLESTIPOL HYDROCHLORIDE 5GM/PACKET GRANULE;ORAL Prescription No AB 077277 IMPAX LABS

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