Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 088571
Company: HOSPIRA
Company: HOSPIRA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE | EPINEPHRINE; LIDOCAINE HYDROCHLORIDE | 0.005MG/ML;1.5% | 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 |
---|---|---|---|---|---|---|---|
09/13/1985 | 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 |
---|---|---|---|---|---|
07/15/2020 | SUPPL-30 | Labeling-Package Insert |
Label is not available on this site. |
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07/15/2020 | SUPPL-28 | Labeling-Package Insert |
Label is not available on this site. |
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04/09/2010 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
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01/02/2002 | SUPPL-7 | Labeling |
Label is not available on this site. |
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12/27/2002 | SUPPL-6 | Labeling |
Label is not available on this site. |
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02/15/1991 | SUPPL-5 | Labeling |
Label is not available on this site. |
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05/10/1989 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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05/07/1987 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE
INJECTABLE;INJECTION; 0.005MG/ML;1.5%
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE | EPINEPHRINE; LIDOCAINE HYDROCHLORIDE | 0.005MG/ML;1.5% | INJECTABLE;INJECTION | Prescription | No | AP | 208475 | B BRAUN MEDICAL INC |
LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE | EPINEPHRINE; LIDOCAINE HYDROCHLORIDE | 0.005MG/ML;1.5% | INJECTABLE;INJECTION | Prescription | No | AP | 088571 | HOSPIRA |
LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE | EPINEPHRINE; LIDOCAINE HYDROCHLORIDE | 0.005MG/ML;1.5% | INJECTABLE;INJECTION | Prescription | No | AP | 089645 | HOSPIRA |
XYLOCAINE W/ EPINEPHRINE | EPINEPHRINE; LIDOCAINE HYDROCHLORIDE | 0.005MG/ML;1.5% | INJECTABLE;INJECTION | Prescription | Yes | AP | 006488 | FRESENIUS KABI USA |