Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 088295
Company: HOSPIRA
Company: HOSPIRA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE | LIDOCAINE HYDROCHLORIDE | 4% | INJECTABLE;INJECTION | Prescription | AP | No | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
05/16/1984 | 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 |
---|---|---|---|---|---|
08/27/2021 | SUPPL-24 | Labeling-Package Insert |
Label is not available on this site. |
||
04/16/2010 | SUPPL-15 | 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. |
||
09/28/1993 | SUPPL-6 | Labeling |
Label is not available on this site. |
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06/29/1989 | SUPPL-4 | Labeling |
Label is not available on this site. |
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12/23/1988 | SUPPL-3 | Labeling |
Label is not available on this site. |
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08/01/1986 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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04/18/1985 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE
INJECTABLE;INJECTION; 4%
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | 4% | INJECTABLE;INJECTION | Prescription | No | AP | 214269 | SINTETICA US |
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE | LIDOCAINE HYDROCHLORIDE | 4% | INJECTABLE;INJECTION | Prescription | No | AP | 017584 | FRESENIUS KABI USA |
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE | LIDOCAINE HYDROCHLORIDE | 4% | INJECTABLE;INJECTION | Prescription | No | AP | 088295 | HOSPIRA |