Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020612
Company: TEIKOKU PHARMA USA
Company: TEIKOKU PHARMA USA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LIDODERM | LIDOCAINE | 5% | PATCH;TOPICAL | Prescription | AB | Yes | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
03/19/1999 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD; Orphan |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20612lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20612ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20612.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
11/02/2018 | SUPPL-14 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020612s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020612Orig1s014ltr.pdf | |
03/17/2016 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/07/2015 | SUPPL-12 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020612s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020612Orig1s012ltr.pdf | |
04/13/2010 | SUPPL-11 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020612s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020612s011ltr.pdf | |
04/27/2006 | SUPPL-8 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020612s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020612s008LTR.pdf | |
05/05/2005 | SUPPL-7 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020612s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020612s007ltr.pdf | |
07/02/2002 | SUPPL-3 | Manufacturing (CMC)-Control |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020612_S003_Lidoderm Patch_APPROVAL PACKAGE.pdf |
05/26/1999 | SUPPL-2 | Manufacturing (CMC)-Control |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020612_S002_Lidoderm Patch_APPROVAL PACKAGE.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
11/02/2018 | SUPPL-14 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020612s014lbl.pdf | |
01/07/2015 | SUPPL-12 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020612s012lbl.pdf | |
01/07/2015 | SUPPL-12 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020612s012lbl.pdf | |
04/13/2010 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020612s011lbl.pdf | |
04/27/2006 | SUPPL-8 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020612s008lbl.pdf | |
05/05/2005 | SUPPL-7 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020612s007lbl.pdf | |
03/19/1999 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20612lbl.pdf |
LIDODERM
PATCH;TOPICAL; 5%
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
LIDOCAINE | LIDOCAINE | 5% | PATCH;TOPICAL | Prescription | No | AB | 200675 | ACTAVIS LABS UT INC |
LIDOCAINE | LIDOCAINE | 5% | PATCH;TOPICAL | Prescription | No | AB | 206463 | AMNEAL |
LIDOCAINE | LIDOCAINE | 5% | PATCH;TOPICAL | Prescription | No | AB | 209190 | IBSA |
LIDOCAINE | LIDOCAINE | 5% | PATCH;TOPICAL | Prescription | No | AB | 202346 | MYLAN TECHNOLOGIES |
LIDOCAINE | LIDOCAINE | 5% | PATCH;TOPICAL | Prescription | No | AB | 205882 | NAL PHARM |
LIDODERM | LIDOCAINE | 5% | PATCH;TOPICAL | Prescription | Yes | AB | 020612 | TEIKOKU PHARMA USA |