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. |
||
| 04/07/2014 | SUPPL-85 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 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. |
||
| 11/05/1998 | SUPPL-66 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/12/1997 | SUPPL-65 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/26/1999 | SUPPL-64 | Labeling |
Label is not available on this site. |
||
| 03/18/1997 | SUPPL-63 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 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. |
||
| 06/26/1996 | SUPPL-58 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 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. |
||
| 01/28/1992 | SUPPL-53 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/10/1991 | SUPPL-52 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/11/1990 | SUPPL-50 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 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. |
||
| 06/10/1985 | SUPPL-43 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/10/1985 | SUPPL-42 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/15/1986 | SUPPL-41 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 01/31/1986 | SUPPL-40 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/26/1985 | SUPPL-39 | Labeling |
Label is not available on this site. |
||
| 11/01/1985 | SUPPL-38 | Labeling |
Label is not available on this site. |
||
| 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. |
||
| 09/26/1985 | SUPPL-31 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/29/1985 | SUPPL-29 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/28/1984 | SUPPL-28 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/13/1989 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 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. |
||
| 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. |
||
| 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. |
||
| 04/21/1981 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 04/21/1981 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/22/1981 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 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 |