Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020695
Company: OTSUKA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
RAXAR GREPAFLOXACIN HYDROCHLORIDE EQ 200MG BASE TABLET;ORAL Discontinued None No No
RAXAR GREPAFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET;ORAL Discontinued None No No
RAXAR GREPAFLOXACIN HYDROCHLORIDE EQ 600MG BASE TABLET;ORAL Discontinued None 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
11/06/1997 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/97/20-695_Raxar_Pharma.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/15/1999 SUPPL-5 Labeling

Label is not available on this site.

09/23/1998 SUPPL-3 Labeling Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20-695s003_Raxar.cfm
08/17/1998 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

05/14/1998 SUPPL-1 Manufacturing (CMC)-Formulation

Label is not available on this site.

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