Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 086364
Company: INTL MEDICATION
Company: INTL MEDICATION
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LARYNG-O-JET KIT | 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 |
|---|---|---|---|---|---|---|---|
| 03/06/1980 | 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 |
|---|---|---|---|---|---|
| 08/18/2015 | SUPPL-35 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/17/1997 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/19/1995 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/20/1994 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/14/1998 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/29/1993 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/19/1993 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/03/1992 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 08/29/1989 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 10/19/1987 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/01/1985 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/13/1985 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/12/1982 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/01/1982 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
LARYNG-O-JET KIT
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 | 087881 | PHARMOBEDIENT |
| LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | 4% | SOLUTION;TOPICAL | Prescription | No | AT | 218182 | SUN PHARMA CANADA |
| LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | 4% | SOLUTION;TOPICAL | Prescription | No | AT | 218411 | THE J MOLNER |