Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 088586
Company: FRESENIUS KABI USA
Company: FRESENIUS KABI USA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER | LIDOCAINE HYDROCHLORIDE | 1% | 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 |
|---|---|---|---|---|---|---|---|
| 07/24/1985 | 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 |
|---|---|---|---|---|---|
| 05/18/2010 | SUPPL-22 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/21/2007 | SUPPL-20 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 12/29/2000 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 07/28/1992 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 03/08/1995 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/01/2000 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/15/1988 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/15/1988 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/15/1988 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/15/1988 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/15/1987 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/22/1988 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/22/1988 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/22/1988 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/12/1985 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER
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 |