Drugs@FDA: FDA-Approved Drugs
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ROMAZICON | FLUMAZENIL | 1MG/10ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
ROMAZICON | FLUMAZENIL | 0.5MG/5ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |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. |
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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. |
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12/05/1994 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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11/29/1994 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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05/10/1995 | SUPPL-4 | Labeling |
Label is not available on this site. |
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10/24/1995 | SUPPL-3 | Labeling |
Label is not available on this site. |
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12/15/1992 | SUPPL-2 | Labeling |
Label is not available on this site. |
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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 |