Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 086283
Company: INTL MEDICATION
Company: INTL MEDICATION
| 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 |
|---|---|---|---|---|---|---|---|
| 08/07/1979 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/22/2025 | SUPPL-30 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/22/2025 | SUPPL-29 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/19/1995 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/17/1994 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/25/1993 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 12/17/1992 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/08/1993 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/10/1987 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/05/1987 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/16/1986 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/16/1986 | SUPPL-2 | Manufacturing (CMC) |
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 |