Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040433
Company: SENTISS
Company: SENTISS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | 2% | JELLY;TOPICAL | Prescription | AT | 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 |
---|---|---|---|---|---|---|---|
02/12/2003 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2003/040433Orig1s000.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
03/25/2020 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
03/10/2017 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
LIDOCAINE HYDROCHLORIDE
JELLY;TOPICAL; 2%
TE Code = AT
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
GLYDO | LIDOCAINE HYDROCHLORIDE | 2% | JELLY;TOPICAL | Prescription | No | AT | 201094 | SAGENT PHARMS INC |
LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | 2% | JELLY;TOPICAL | Prescription | No | AT | 086283 | INTL MEDICATION |
LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | 2% | JELLY;TOPICAL | Prescription | No | AT | 040433 | SENTISS |