Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 076203
Company: KADMON PHARMS LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
RIBASPHERE RIBAVIRIN 200MG CAPSULE;ORAL Prescription AB No 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
04/06/2004 ORIG-1 Approval Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/76203LBL_Ribasphere.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76203ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/31/2014 SUPPL-18 Labeling-Package Insert

Label is not available on this site.

03/18/2013 SUPPL-16 REMS

Label is not available on this site.

02/28/2011 SUPPL-15 Labeling-Package Insert

Label is not available on this site.

08/25/2008 SUPPL-14 Labeling

Label is not available on this site.

04/14/2008 SUPPL-13 Labeling

Label is not available on this site.

01/09/2007 SUPPL-11 Labeling

Label is not available on this site.

07/08/2005 SUPPL-8 Labeling

Label is not available on this site.

02/10/2005 SUPPL-7 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/06/2004 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/76203LBL_Ribasphere.pdf

RIBASPHERE

CAPSULE;ORAL; 200MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
REBETOL RIBAVIRIN 200MG CAPSULE;ORAL Prescription Yes AB 020903 MERCK SHARP DOHME
RIBASPHERE RIBAVIRIN 200MG CAPSULE;ORAL Prescription No AB 076203 KADMON PHARMS LLC
RIBAVIRIN RIBAVIRIN 200MG CAPSULE;ORAL Prescription No AB 079117 AUROBINDO PHARMA
RIBAVIRIN RIBAVIRIN 200MG CAPSULE;ORAL Prescription No AB 076192 CASI PHARMS INC
RIBAVIRIN RIBAVIRIN 200MG CAPSULE;ORAL Prescription No AB 076277 TEVA
RIBAVIRIN RIBAVIRIN 200MG CAPSULE;ORAL Prescription No AB 077224 ZYDUS PHARMS USA

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English