Drugs@FDA: FDA-Approved Drugs
Company: PFIZER
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
FLAGYL I.V. | METRONIDAZOLE HYDROCHLORIDE | EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | No | No |
FLAGYL I.V. RTU IN PLASTIC CONTAINER | METRONIDAZOLE | 500MG/100ML | INJECTABLE;INJECTION | 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 |
---|---|---|---|---|---|---|---|
11/28/1980 | ORIG-1 | Approval | Type 3 - New Dosage Form | 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 |
---|---|---|---|---|---|
07/13/2015 | SUPPL-27 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018353s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018353Orig1s027ltr.pdf | |
08/16/2013 | SUPPL-26 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018353s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018353Orig1s026ltr.pdf | |
03/05/1993 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
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11/30/1992 | SUPPL-24 | Labeling |
Label is not available on this site. |
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04/13/1989 | SUPPL-23 | Labeling |
Label is not available on this site. |
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02/17/1988 | SUPPL-22 | Labeling |
Label is not available on this site. |
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09/09/1986 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
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09/02/1986 | SUPPL-20 | Labeling |
Label is not available on this site. |
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04/24/1986 | SUPPL-18 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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06/20/1986 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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02/17/1988 | SUPPL-16 | Labeling |
Label is not available on this site. |
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02/17/1988 | SUPPL-15 | Efficacy-New Patient Population |
Label is not available on this site. |
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02/17/1988 | SUPPL-14 | Labeling |
Label is not available on this site. |
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10/29/1987 | SUPPL-13 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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08/21/1987 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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12/14/1983 | SUPPL-10 | Labeling |
Label is not available on this site. |
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12/02/1982 | SUPPL-9 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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09/15/1982 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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06/30/1982 | SUPPL-7 | Labeling |
Label is not available on this site. |
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01/11/1982 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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11/02/1981 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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11/25/1981 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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12/20/1984 | SUPPL-2 | Labeling |
Label is not available on this site. |
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05/29/1981 | 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 |
---|---|---|---|---|---|
07/13/2015 | SUPPL-27 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018353s027lbl.pdf | |
08/16/2013 | SUPPL-26 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018353s026lbl.pdf |