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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020491
Company: PFIZER

Products on NDA 020491

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CORVERT	IBUTILIDE FUMARATE	0.1MG/ML	INJECTABLE;INJECTION	Prescription	AP	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020491

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/28/1995	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/020491Orig1s000rev.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/09/2014	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
10/17/2002	SUPPL-5	Manufacturing (CMC)-Control		Label is not available on this site.
04/03/2000	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
04/20/2001	SUPPL-3	Labeling	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-491S003.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-491S003.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-491S003.pdf
04/03/1998	SUPPL-2	Labeling	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20491s002_Corvert.pdf
05/13/1999	SUPPL-1	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20491s01lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20491s01ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20491s001.cfm

Labels for NDA 020491

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/20/2001	SUPPL-3	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-491S003.pdf
05/13/1999	SUPPL-1	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20491s01lbl.pdf

Therapeutic Equivalents for NDA 020491

CORVERT

INJECTABLE;INJECTION; 0.1MG/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CORVERT	IBUTILIDE FUMARATE	0.1MG/ML	INJECTABLE;INJECTION	Prescription	Yes	AP	020491	PFIZER
IBUTILIDE FUMARATE	IBUTILIDE FUMARATE	0.1MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	204146	AVET LIFESCIENCES
IBUTILIDE FUMARATE	IBUTILIDE FUMARATE	0.1MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	090643	MYLAN INSTITUTIONAL

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