Drugs@FDA: FDA-Approved Drugs
Company: BAXTER HLTHCARE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LIDOCAINE HYDROCHLORIDE 0.1% AND DEXTROSE 5% IN PLASTIC CONTAINER | LIDOCAINE HYDROCHLORIDE | 100MG/100ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER | LIDOCAINE HYDROCHLORIDE | 200MG/100ML | INJECTABLE;INJECTION | Prescription | AP | No | No |
| LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER | LIDOCAINE HYDROCHLORIDE | 400MG/100ML | INJECTABLE;INJECTION | Prescription | AP | No | No |
| LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER | LIDOCAINE HYDROCHLORIDE | 800MG/100ML | INJECTABLE;INJECTION | Prescription | AP | 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 |
|---|---|---|---|---|---|---|---|
| 04/22/1981 | ORIG-1 | Approval | Type 3 - New Dosage Form | 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 |
|---|---|---|---|---|---|
| 02/07/2017 | SUPPL-58 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018461s058lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018461Orig1s058ltr.pdf | |
| 04/07/2015 | SUPPL-57 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/05/2012 | SUPPL-56 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018461s056lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/018461s056ltr.pdf | |
| 02/27/2012 | SUPPL-55 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/018461s055ltr.pdf |
| 12/11/2003 | SUPPL-52 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18461slr052ltr.pdf |
| 01/23/2002 | SUPPL-50 | Labeling |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/18-461S050_Lidocaine.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18461s50ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/18-461S050_Lidocaine.pdf | |
| 11/23/1999 | SUPPL-48 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/03/1999 | SUPPL-47 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/18/1998 | SUPPL-46 | Labeling |
Label is not available on this site. |
||
| 09/29/1994 | SUPPL-45 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/16/1994 | SUPPL-44 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/08/1993 | SUPPL-43 | Labeling |
Label is not available on this site. |
||
| 04/03/1991 | SUPPL-41 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/29/1991 | SUPPL-40 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/24/1990 | SUPPL-39 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/26/1991 | SUPPL-38 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/15/1991 | SUPPL-37 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/26/1989 | SUPPL-36 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/12/1989 | SUPPL-35 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/25/1987 | SUPPL-33 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/28/1987 | SUPPL-32 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/19/1986 | SUPPL-31 | Labeling |
Label is not available on this site. |
||
| 02/27/1986 | SUPPL-28 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/15/1985 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/13/1985 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 06/13/1985 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/23/1984 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/04/1986 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 02/28/1984 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/30/1984 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 06/11/1985 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/14/1983 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/24/1985 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/16/1984 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/25/1982 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 11/20/1981 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/22/1982 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 02/22/1982 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/03/1982 | 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. |
||
| 10/01/1981 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/16/1982 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/21/1981 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/27/1981 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 07/22/1981 | 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 |
|---|---|---|---|---|---|
| 02/07/2017 | SUPPL-58 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018461s058lbl.pdf | |
| 03/05/2012 | SUPPL-56 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018461s056lbl.pdf | |
| 01/23/2002 | SUPPL-50 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/18-461S050_Lidocaine.pdf |
LIDOCAINE HYDROCHLORIDE 0.1% AND DEXTROSE 5% IN PLASTIC CONTAINER
There are no Therapeutic Equivalents.
LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER
INJECTABLE;INJECTION; 200MG/100ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER | LIDOCAINE HYDROCHLORIDE | 200MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 019830 | B BRAUN |
| LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER | LIDOCAINE HYDROCHLORIDE | 200MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 018461 | BAXTER HLTHCARE |
LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER
INJECTABLE;INJECTION; 400MG/100ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER | LIDOCAINE HYDROCHLORIDE | 400MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 019830 | B BRAUN |
| LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER | LIDOCAINE HYDROCHLORIDE | 400MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 018461 | BAXTER HLTHCARE |
LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER
INJECTABLE;INJECTION; 800MG/100ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER | LIDOCAINE HYDROCHLORIDE | 800MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 019830 | B BRAUN |
| LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER | LIDOCAINE HYDROCHLORIDE | 800MG/100ML | INJECTABLE;INJECTION | Prescription | No | AP | 018461 | BAXTER HLTHCARE |