Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020942
Company: ROCHE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VERSED MIDAZOLAM HYDROCHLORIDE EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** SYRUP;ORAL Discontinued None Yes No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
10/15/1998 ORIG-1 Approval Type 3 - New Dosage Form PRIORITY Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20942_Versed_approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020942_versed_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/25/2000 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

05/17/2001 SUPPL-4 Labeling

Label is not available on this site.

06/30/2000 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

11/24/1999 SUPPL-1 Manufacturing (CMC)-Packaging

Label is not available on this site.

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