Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020491
Company: PHARMACIA AND UPJOHN
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
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
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

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 PHARMACIA AND UPJOHN
IBUTILIDE FUMARATE IBUTILIDE FUMARATE 0.1MG/ML INJECTABLE;INJECTION Prescription No AP 090643 MYLAN INSTITUTIONAL

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