Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 088802
Company: HIKMA
Company: HIKMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LIDOCAINE VISCOUS | LIDOCAINE HYDROCHLORIDE | 2% | SOLUTION;ORAL | 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 |
|---|---|---|---|---|---|---|---|
| 04/26/1985 | 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 |
|---|---|---|---|---|---|
| 11/02/2018 | SUPPL-25 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/17/2014 | SUPPL-23 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/30/2008 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 02/14/2002 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/15/1998 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/28/1996 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/29/1996 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 06/30/1995 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/01/1994 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/12/1991 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 03/21/1991 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 11/16/1990 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 10/11/1988 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/27/1987 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/27/1987 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/17/1986 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
LIDOCAINE VISCOUS
SOLUTION;ORAL; 2%
TE Code = AT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | 2% | SOLUTION;ORAL | Prescription | No | AT | 216780 | RUBICON |
| LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | 2% | SOLUTION;ORAL | Prescription | No | AT | 087872 | WOCKHARDT BIO AG |
| LIDOCAINE HYDROCHLORIDE VISCOUS | LIDOCAINE HYDROCHLORIDE | 2% | SOLUTION;ORAL | Prescription | No | AT | 040708 | CHARTWELL MOLECULAR |
| LIDOCAINE HYDROCHLORIDE VISCOUS | LIDOCAINE HYDROCHLORIDE | 2% | SOLUTION;ORAL | Prescription | No | AT | 218138 | PAI HOLDINGS PHARM |
| LIDOCAINE VISCOUS | LIDOCAINE HYDROCHLORIDE | 2% | SOLUTION;ORAL | Prescription | No | AT | 088802 | HIKMA |