Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 087881
Company: WOCKHARDT BIO AG
Company: WOCKHARDT BIO AG
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | 4% | SOLUTION;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 |
|---|---|---|---|---|---|---|---|
| 11/18/1982 | 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 |
|---|---|---|---|---|---|
| 10/19/2015 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/13/2002 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/15/2002 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 02/16/1994 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 05/28/1992 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 09/06/1989 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 05/14/1987 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/06/1983 | SUPPL-1 | Manufacturing (CMC) |
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 |