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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 017563
Company: PFIZER

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
COLESTID COLESTIPOL HYDROCHLORIDE 5GM/SCOOPFUL GRANULE;ORAL Prescription AB Yes No
COLESTID COLESTIPOL HYDROCHLORIDE 5GM/PACKET GRANULE;ORAL Prescription AB Yes Yes
FLAVORED COLESTID COLESTIPOL HYDROCHLORIDE 5GM/PACKET GRANULE;ORAL Prescription None Yes No
FLAVORED COLESTID COLESTIPOL HYDROCHLORIDE 5GM/SCOOPFUL GRANULE;ORAL Prescription None Yes 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
04/04/1977 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/25/2018 SUPPL-24 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/017563Orig1s024ltr.pdf
05/22/2014 SUPPL-23 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017563s023,020222s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/017563Orig1s023,20222Orig1s005ltr.pdf
09/22/1995 SUPPL-21 Labeling

Label is not available on this site.
01/18/1996 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.
03/26/1996 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.
04/09/1992 SUPPL-17 Labeling

Label is not available on this site.
12/18/1991 SUPPL-16 Labeling

Label is not available on this site.
06/01/1992 SUPPL-15 Manufacturing (CMC)-Packaging

Label is not available on this site.
06/17/1991 SUPPL-14 Labeling

Label is not available on this site.
12/06/1993 SUPPL-13 Manufacturing (CMC)-Formulation

Label is not available on this site.
08/06/1991 SUPPL-12 Labeling

Label is not available on this site.
07/27/1990 SUPPL-11 Labeling

Label is not available on this site.
04/03/1987 SUPPL-10 Manufacturing (CMC)-Expiration Date

Label is not available on this site.
11/24/1986 SUPPL-9 Labeling

Label is not available on this site.
02/25/1985 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.
02/19/1982 SUPPL-6 Labeling

Label is not available on this site.
02/19/1982 SUPPL-5 Labeling

Label is not available on this site.
02/19/1982 SUPPL-4 Labeling

Label is not available on this site.
04/17/1979 SUPPL-3 Labeling

Label is not available on this site.
07/23/1979 SUPPL-2 Manufacturing (CMC)-Packaging

Label is not available on this site.
05/16/1977 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
05/22/2014 SUPPL-23 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017563s023,020222s005lbl.pdf

COLESTID

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 PFIZER
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 PFIZER
COLESTIPOL HYDROCHLORIDE COLESTIPOL HYDROCHLORIDE 5GM/PACKET GRANULE;ORAL Prescription No AB 077277 IMPAX LABS

FLAVORED COLESTID

There are no Therapeutic Equivalents.

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