Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 088803
Company: HIKMA
Company: HIKMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | 4% | SOLUTION;TOPICAL | Prescription | AT | No | 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 |
|---|---|---|---|---|---|---|---|
| 04/03/1985 | 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 |
|---|---|---|---|---|---|
| 08/20/2021 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/30/2008 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 03/27/2000 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/27/2000 | SUPPL-9 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/28/1996 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/18/1991 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 03/04/1991 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/31/1989 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 09/27/1988 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/27/1988 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/01/1988 | SUPPL-2 | Bioequivalence |
Label is not available on this site. |
||
| 10/17/1988 | SUPPL-1 | Labeling |
Label is not available on this site. |
LIDOCAINE HYDROCHLORIDE
SOLUTION;TOPICAL; 4%
TE Code = AT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| LARYNG-O-JET KIT | LIDOCAINE HYDROCHLORIDE | 4% | SOLUTION;TOPICAL | Prescription | No | AT | 086364 | INTL MEDICATION |
| LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | 4% | SOLUTION;TOPICAL | Prescription | No | AT | 088803 | HIKMA |
| LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | 4% | SOLUTION;TOPICAL | Prescription | No | AT | 040710 | LANNETT CO INC |
| LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | 4% | SOLUTION;TOPICAL | Prescription | No | AT | 216250 | NOVITIUM PHARMA |
| LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | 4% | SOLUTION;TOPICAL | Prescription | No | AT | 204494 | PAI HOLDINGS PHARM |
| LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | 4% | SOLUTION;TOPICAL | Prescription | No | AT | 218182 | TARO |
| LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | 4% | SOLUTION;TOPICAL | Prescription | No | AT | 218411 | THE J MOLNER |
| LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | 4% | SOLUTION;TOPICAL | Prescription | No | AT | 087881 | WOCKHARDT BIO AG |