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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018859
Company: BAUSCH

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VIRAZOLE RIBAVIRIN 6GM/VIAL FOR SOLUTION;INHALATION Prescription AN 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
12/31/1985 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY Review (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018859Orig1s000rev.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/06/2016 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.
06/27/2014 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.
02/28/2000 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.
03/26/1998 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.
09/26/1994 SUPPL-24 Labeling

Label is not available on this site.
03/10/1994 SUPPL-23 Manufacturing (CMC)-Packaging

Label is not available on this site.
04/01/1993 SUPPL-22 Labeling

Label is not available on this site.
07/12/1993 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.
06/06/1990 SUPPL-17 Labeling

Label is not available on this site.
03/04/1993 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.
03/13/1989 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.
03/13/1989 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.
09/23/1992 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.
03/28/1989 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.
09/15/1988 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.
06/02/1989 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.
04/09/1987 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.
02/05/1993 SUPPL-3 Efficacy-New Patient Population

Label is not available on this site.
08/27/1986 SUPPL-2 Manufacturing (CMC)-Expiration Date

Label is not available on this site.
08/27/1986 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

VIRAZOLE

FOR SOLUTION;INHALATION; 6GM/VIAL
TE Code = AN

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
RIBAVIRIN RIBAVIRIN 6GM/VIAL FOR SOLUTION;INHALATION Prescription No AN 207366 NAVINTA LLC
VIRAZOLE RIBAVIRIN 6GM/VIAL FOR SOLUTION;INHALATION Prescription Yes AN 018859 BAUSCH
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