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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020222
Company: PFIZER

Products on NDA 020222

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
COLESTID	COLESTIPOL HYDROCHLORIDE	1GM	TABLET;ORAL	Prescription	AB	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020222

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/19/1994	ORIG-1	Approval	Type 3 - New Dosage Form	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
05/25/2017	SUPPL-6	Labeling-Container/Carton Labels, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020222Orig1s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020222Orig1s006ltr.pdf
05/22/2014	SUPPL-5	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
04/12/2002	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
09/22/1995	SUPPL-1	Labeling		Label is not available on this site.

Labels for NDA 020222

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/25/2017	SUPPL-6	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020222Orig1s006lbl.pdf
05/25/2017	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020222Orig1s006lbl.pdf
05/22/2014	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/017563s023,020222s005lbl.pdf

Therapeutic Equivalents for NDA 020222

COLESTID

TABLET;ORAL; 1GM
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
COLESTID	COLESTIPOL HYDROCHLORIDE	1GM	TABLET;ORAL	Prescription	Yes	AB	020222	PFIZER
COLESTIPOL HYDROCHLORIDE	COLESTIPOL HYDROCHLORIDE	1GM	TABLET;ORAL	Prescription	No	AB	216517	ANI PHARMS
COLESTIPOL HYDROCHLORIDE	COLESTIPOL HYDROCHLORIDE	1GM	TABLET;ORAL	Prescription	No	AB	077510	IMPAX LABS
COLESTIPOL HYDROCHLORIDE	COLESTIPOL HYDROCHLORIDE	1GM	TABLET;ORAL	Prescription	No	AB	215223	ZYDUS PHARMS

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