Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020073
Company: HOFFMANN LA ROCHE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ROMAZICON FLUMAZENIL 1MG/10ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No
ROMAZICON FLUMAZENIL 0.5MG/5ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No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
12/20/1991 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/04/2007 SUPPL-16 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020073s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020073s016ltr.pdf
11/12/2002 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

06/06/2001 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

03/03/2004 SUPPL-11 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/020073s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20073slr011ltr.pdf
05/22/2000 SUPPL-10 Labeling

Label is not available on this site.

11/14/1997 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

09/21/1998 SUPPL-8 Labeling

Label is not available on this site.

07/12/1994 SUPPL-7 Labeling

Label is not available on this site.

12/05/1994 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

11/29/1994 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

05/10/1995 SUPPL-4 Labeling

Label is not available on this site.

10/24/1995 SUPPL-3 Labeling

Label is not available on this site.

12/15/1992 SUPPL-2 Labeling

Label is not available on this site.

09/11/1992 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/04/2007 SUPPL-16 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020073s016lbl.pdf
03/03/2004 SUPPL-11 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/020073s011lbl.pdf

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