Drugs@FDA: FDA-Approved Drugs
Company: HOSPIRA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LIDOCAINE HYDROCHLORIDE 0.2% IN DEXTROSE 5% IN PLASTIC CONTAINER | LIDOCAINE HYDROCHLORIDE | 200MG/100ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5% IN PLASTIC CONTAINER | LIDOCAINE HYDROCHLORIDE | 400MG/100ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
LIDOCAINE HYDROCHLORIDE 0.8% IN DEXTROSE 5% IN PLASTIC CONTAINER | LIDOCAINE HYDROCHLORIDE | 800MG/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 |
---|---|---|---|---|---|---|---|
12/19/1980 | ORIG-1 | Approval | Type 4 - New Combination | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
05/09/2014 | SUPPL-86 | Manufacturing (CMC) |
Label is not available on this site. |
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04/07/2014 | SUPPL-85 | Manufacturing (CMC) |
Label is not available on this site. |
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01/15/2014 | SUPPL-84 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018388s084lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018388Orig1s084ltr.pdf | |
08/26/1999 | SUPPL-67 | Labeling |
Label is not available on this site. |
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11/05/1998 | SUPPL-66 | Manufacturing (CMC) |
Label is not available on this site. |
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06/12/1997 | SUPPL-65 | Manufacturing (CMC) |
Label is not available on this site. |
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08/26/1999 | SUPPL-64 | Labeling |
Label is not available on this site. |
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03/18/1997 | SUPPL-63 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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07/09/1996 | SUPPL-62 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
02/02/1996 | SUPPL-61 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
08/03/1995 | SUPPL-60 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/17/1996 | SUPPL-59 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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06/26/1996 | SUPPL-58 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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08/17/1995 | SUPPL-56 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
11/03/1993 | SUPPL-55 | Labeling |
Label is not available on this site. |
||
08/30/1991 | SUPPL-54 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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01/28/1992 | SUPPL-53 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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09/10/1991 | SUPPL-52 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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01/11/1990 | SUPPL-50 | Manufacturing (CMC) |
Label is not available on this site. |
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02/22/1990 | SUPPL-49 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/01/1992 | SUPPL-48 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
11/26/1986 | SUPPL-45 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
08/08/1986 | SUPPL-44 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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06/10/1985 | SUPPL-43 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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05/10/1985 | SUPPL-42 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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12/15/1986 | SUPPL-41 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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01/31/1986 | SUPPL-40 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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10/26/1985 | SUPPL-39 | Labeling |
Label is not available on this site. |
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11/01/1985 | SUPPL-38 | Labeling |
Label is not available on this site. |
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05/03/1985 | SUPPL-37 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
10/26/1985 | SUPPL-36 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
11/01/1985 | SUPPL-33 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
10/22/1984 | SUPPL-32 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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09/26/1985 | SUPPL-31 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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10/29/1985 | SUPPL-29 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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11/28/1984 | SUPPL-28 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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09/13/1989 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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04/09/1984 | SUPPL-26 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
10/17/1984 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
03/21/1984 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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09/06/1983 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
06/16/1983 | SUPPL-21 | Labeling |
Label is not available on this site. |
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12/08/1983 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
02/17/1984 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
10/10/1984 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
10/10/1984 | SUPPL-17 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
07/26/1982 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
03/01/1984 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
02/15/1983 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/08/1982 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
11/05/1982 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
11/05/1982 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
02/01/1982 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
01/08/1982 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
06/09/1982 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
10/01/1981 | SUPPL-6 | Labeling |
Label is not available on this site. |
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04/21/1981 | SUPPL-5 | Labeling |
Label is not available on this site. |
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04/21/1981 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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04/22/1981 | SUPPL-3 | Labeling |
Label is not available on this site. |
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05/16/1981 | SUPPL-2 | 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 |
---|---|---|---|---|---|
01/15/2014 | SUPPL-84 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018388s084lbl.pdf |