Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 088328
Company: HOSPIRA
Company: HOSPIRA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | 0.5% | 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 |
---|---|---|---|---|---|---|---|
05/17/1984 | 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 |
---|---|---|---|---|---|
03/19/2020 | SUPPL-30 | Labeling-Package Insert |
Label is not available on this site. |
||
03/19/2020 | SUPPL-29 | Labeling-Package Insert |
Label is not available on this site. |
||
04/16/2010 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
||
10/03/1996 | SUPPL-8 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
10/22/1996 | SUPPL-7 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
10/10/1990 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
12/12/1988 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
08/15/1986 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/18/1985 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
LIDOCAINE HYDROCHLORIDE
INJECTABLE;INJECTION; 0.5%
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | 0.5% | INJECTABLE;INJECTION | Prescription | No | AP | 088328 | HOSPIRA |
LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER | LIDOCAINE HYDROCHLORIDE | 0.5% | INJECTABLE;INJECTION | Prescription | No | AP | 088325 | HOSPIRA |
XYLOCAINE | LIDOCAINE HYDROCHLORIDE | 0.5% | INJECTABLE;INJECTION | Prescription | Yes | AP | 006488 | FRESENIUS KABI USA |