Drugs@FDA: FDA-Approved Drugs
Company: FRESENIUS KABI USA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SENSORCAINE | BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE | 0.25%;0.0091MG/ML | 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 |
---|---|---|---|---|---|---|---|
10/13/1987 | 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 |
---|---|---|---|---|---|
11/02/2022 | SUPPL-38 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
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09/01/2015 | SUPPL-28 | Labeling-Package Insert |
Label is not available on this site. |
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05/19/2010 | SUPPL-20 | Labeling-Package Insert |
Label is not available on this site. |
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03/08/2002 | SUPPL-17 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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06/08/2001 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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05/21/2001 | SUPPL-15 | Labeling |
Label is not available on this site. |
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08/25/1997 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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04/14/1997 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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05/31/1996 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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09/11/1992 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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03/10/1993 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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05/13/1992 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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09/12/1991 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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12/03/1991 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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12/03/1991 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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09/12/1991 | SUPPL-2 | Labeling |
Label is not available on this site. |
SENSORCAINE
INJECTABLE;INJECTION; 0.25%;0.0091MG/ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
MARCAINE HYDROCHLORIDE W/ EPINEPHRINE | BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE | 0.25%;0.0091MG/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 016964 | HOSPIRA |
MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE | BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE | 0.25%;0.0091MG/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 016964 | HOSPIRA |
SENSORCAINE | BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE | 0.25%;0.0091MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 070966 | FRESENIUS KABI USA |
SENSORCAINE | BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE | 0.25%;0.0091MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 070967 | FRESENIUS KABI USA |