Drugs@FDA: FDA-Approved Drugs
Company: B BRAUN
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
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 |
---|---|---|---|---|---|---|---|
04/08/1992 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | 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 |
---|---|---|---|---|---|
05/19/2020 | SUPPL-27 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/019830s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/019830Orig1s027ltr.pdf | |
01/13/2017 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
02/01/2013 | SUPPL-18 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019830s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019830Orig1s018ltr.pdf | |
08/22/2014 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/24/2004 | SUPPL-8 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19830slr008ltr.pdf |
07/15/2002 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
03/04/2002 | SUPPL-5 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
03/13/2001 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
07/20/1998 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/31/1994 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
03/16/1993 | SUPPL-1 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
05/19/2020 | SUPPL-27 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/019830s027lbl.pdf | |
02/01/2013 | SUPPL-18 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019830s018lbl.pdf |
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 |