Drugs@FDA: FDA-Approved Drugs
Company: HOSPIRA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE | EPINEPHRINE; LIDOCAINE HYDROCHLORIDE | 0.01MG/ML;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 |
---|---|---|---|---|---|---|---|
06/21/1988 | 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-34 | Labeling-Package Insert |
Label is not available on this site. |
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07/15/2020 | SUPPL-31 | Labeling-Package Insert |
Label is not available on this site. |
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04/12/2010 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
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09/03/2002 | SUPPL-8 | Manufacturing (CMC)-Expiration Date |
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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05/26/1998 | SUPPL-6 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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05/26/1998 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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09/26/1997 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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11/09/1990 | SUPPL-3 | Labeling |
Label is not available on this site. |
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03/21/1990 | SUPPL-2 | Labeling |
Label is not available on this site. |
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07/06/1989 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE
INJECTABLE;INJECTION; 0.01MG/ML;1%
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 | 0.01MG/ML;1% | INJECTABLE;INJECTION | Prescription | No | AP | 089644 | HOSPIRA |
XYLOCAINE W/ EPINEPHRINE | EPINEPHRINE; LIDOCAINE HYDROCHLORIDE | 0.01MG/ML;1% | INJECTABLE;INJECTION | Prescription | Yes | AP | 006488 | FRESENIUS KABI USA |