Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 080404
Company: FRESENIUS KABI USA
Company: FRESENIUS KABI USA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | 1% | INJECTABLE;INJECTION | Prescription | AP | No | No |
| LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | 2% | INJECTABLE;INJECTION | Prescription | AP | 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 |
|---|---|---|---|---|---|---|---|
| 12/29/1971 | 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 |
|---|---|---|---|---|---|
| 05/18/2010 | SUPPL-43 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/29/2000 | SUPPL-39 | Labeling |
Label is not available on this site. |
||
| 07/10/1992 | SUPPL-37 | Labeling |
Label is not available on this site. |
||
| 03/08/1995 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/01/1999 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/15/1989 | SUPPL-34 | Labeling |
Label is not available on this site. |
||
| 04/21/1988 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/05/1988 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/18/1985 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/28/1984 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/01/1984 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/06/1983 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/06/1983 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/15/1983 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/23/1982 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
LIDOCAINE HYDROCHLORIDE
INJECTABLE;INJECTION; 1%
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | 1% | INJECTABLE;INJECTION | Prescription | No | AP | 215132 | AFAXYS |
| LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | 1% | INJECTABLE;INJECTION | Prescription | No | AP | 214336 | ASPIRO |
| LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | 1% | INJECTABLE;INJECTION | Prescription | No | AP | 214339 | ASPIRO |
| LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | 1% | INJECTABLE;INJECTION | Prescription | No | AP | 208474 | B BRAUN MEDICAL INC |
| LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | 1% | INJECTABLE;INJECTION | Prescription | No | AP | 207182 | EUGIA PHARMA |
| LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | 1% | INJECTABLE;INJECTION | Prescription | No | AP | 080404 | FRESENIUS KABI USA |
| LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | 1% | INJECTABLE;INJECTION | Prescription | Yes | AP | 083158 | HOSPIRA |
| LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | 1% | INJECTABLE;INJECTION | Prescription | No | AP | 088329 | HOSPIRA |
| LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | 1% | INJECTABLE;INJECTION | Prescription | No | AP | 212821 | HUONS |
| LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | 1% | INJECTABLE;INJECTION | Prescription | No | AP | 083173 | INTL MEDICATION |
| LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | 1% | INJECTABLE;INJECTION | Prescription | No | AP | 217692 | MANKIND PHARMA |
| LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | 1% | INJECTABLE;INJECTION | Prescription | No | AP | 217693 | MANKIND PHARMA |
| LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | 1% | INJECTABLE;INJECTION | Prescription | No | AP | 214267 | SINTETICA US |
| LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | 1% | INJECTABLE;INJECTION | Prescription | No | AP | 208017 | SPECTRA MDCL DEVICES |
| LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | 1% | INJECTABLE;INJECTION | Prescription | No | AP | 080407 | WEST-WARD PHARMS INT |
| LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER | LIDOCAINE HYDROCHLORIDE | 1% | INJECTABLE;INJECTION | Prescription | No | AP | 088586 | FRESENIUS KABI USA |
| LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER | LIDOCAINE HYDROCHLORIDE | 1% | INJECTABLE;INJECTION | Prescription | No | AP | 088299 | HOSPIRA |
| LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE | LIDOCAINE HYDROCHLORIDE | 1% | INJECTABLE;INJECTION | Prescription | No | AP | 203040 | EUGIA PHARMA |
| LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE | LIDOCAINE HYDROCHLORIDE | 1% | INJECTABLE;INJECTION | Prescription | No | AP | 203082 | EUGIA PHARMA |
| LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE | LIDOCAINE HYDROCHLORIDE | 1% | INJECTABLE;INJECTION | Prescription | No | AP | 080408 | HOSPIRA |
| LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE | LIDOCAINE HYDROCHLORIDE | 1% | INJECTABLE;INJECTION | Prescription | No | AP | 084625 | WEST-WARD PHARMS INT |
| LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE IN PLASTIC CONTAINER | LIDOCAINE HYDROCHLORIDE | 1% | INJECTABLE;INJECTION | Prescription | No | AP | 040302 | HOSPIRA |
| XYLOCAINE | LIDOCAINE HYDROCHLORIDE | 1% | INJECTABLE;INJECTION | Prescription | Yes | AP | 006488 | FRESENIUS KABI USA |
INJECTABLE;INJECTION; 2%
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | 2% | INJECTABLE;INJECTION | Prescription | No | AP | 214336 | ASPIRO |
| LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | 2% | INJECTABLE;INJECTION | Prescription | No | AP | 214339 | ASPIRO |
| LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | 2% | INJECTABLE;INJECTION | Prescription | No | AP | 207182 | EUGIA PHARMA |
| LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | 2% | INJECTABLE;INJECTION | Prescription | No | AP | 080404 | FRESENIUS KABI USA |
| LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | 2% | INJECTABLE;INJECTION | Prescription | No | AP | 040078 | HOSPIRA |
| LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | 2% | INJECTABLE;INJECTION | Prescription | Yes | AP | 083158 | HOSPIRA |
| LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | 2% | INJECTABLE;INJECTION | Prescription | No | AP | 088294 | HOSPIRA |
| LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | 2% | INJECTABLE;INJECTION | Prescription | No | AP | 212821 | HUONS |
| LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | 2% | INJECTABLE;INJECTION | Prescription | No | AP | 083173 | INTL MEDICATION |
| LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | 2% | INJECTABLE;INJECTION | Prescription | No | AP | 217692 | MANKIND PHARMA |
| LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | 2% | INJECTABLE;INJECTION | Prescription | No | AP | 217693 | MANKIND PHARMA |
| LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | 2% | INJECTABLE;INJECTION | Prescription | No | AP | 214267 | SINTETICA US |
| LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | 2% | INJECTABLE;INJECTION | Prescription | No | AP | 080407 | WEST-WARD PHARMS INT |
| LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER | LIDOCAINE HYDROCHLORIDE | 2% | INJECTABLE;INJECTION | Prescription | No | AP | 088327 | HOSPIRA |
| LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE | LIDOCAINE HYDROCHLORIDE | 2% | INJECTABLE;INJECTION | Prescription | No | AP | 203040 | EUGIA PHARMA |
| LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE | LIDOCAINE HYDROCHLORIDE | 2% | INJECTABLE;INJECTION | Prescription | No | AP | 203082 | EUGIA PHARMA |
| LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE | LIDOCAINE HYDROCHLORIDE | 2% | INJECTABLE;INJECTION | Prescription | No | AP | 017584 | FRESENIUS KABI USA |
| LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE | LIDOCAINE HYDROCHLORIDE | 2% | INJECTABLE;INJECTION | Prescription | No | AP | 084625 | WEST-WARD PHARMS INT |
| LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE IN PLASTIC CONTAINER | LIDOCAINE HYDROCHLORIDE | 2% | INJECTABLE;INJECTION | Prescription | No | AP | 040302 | HOSPIRA |
| XYLOCAINE | LIDOCAINE HYDROCHLORIDE | 2% | INJECTABLE;INJECTION | Prescription | Yes | AP | 006488 | FRESENIUS KABI USA |