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 | 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 |
---|---|---|---|---|---|---|---|
05/21/1986 | 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-29 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
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09/01/2015 | SUPPL-22 | Labeling-Package Insert |
Label is not available on this site. |
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05/17/2010 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
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03/08/2002 | SUPPL-15 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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06/08/2001 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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05/21/2001 | SUPPL-13 | Labeling |
Label is not available on this site. |
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08/25/1997 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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09/27/1996 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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05/31/1996 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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09/11/1992 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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03/10/1993 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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05/12/1992 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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12/18/1990 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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09/03/1991 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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09/03/1991 | SUPPL-1 | Labeling |
Label is not available on this site. |
SENSORCAINE
INJECTABLE;INJECTION; 0.5%
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
BUPIVACAINE HYDROCHLORIDE | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE;INJECTION | Prescription | No | AP | 217821 | ASPIRO |
BUPIVACAINE HYDROCHLORIDE | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE;INJECTION | Prescription | No | AP | 207183 | EUGIA PHARMA |
BUPIVACAINE HYDROCHLORIDE | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE;INJECTION | Prescription | No | AP | 205141 | HIKMA PHARMS |
BUPIVACAINE HYDROCHLORIDE | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE;INJECTION | Prescription | No | AP | 070584 | HOSPIRA |
BUPIVACAINE HYDROCHLORIDE | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE;INJECTION | Prescription | No | AP | 070597 | HOSPIRA |
BUPIVACAINE HYDROCHLORIDE | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE;INJECTION | Prescription | No | AP | 070609 | HOSPIRA |
BUPIVACAINE HYDROCHLORIDE | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE;INJECTION | Prescription | No | AP | 216039 | MEITHEAL |
BUPIVACAINE HYDROCHLORIDE | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE;INJECTION | Prescription | No | AP | 216040 | MEITHEAL |
BUPIVACAINE HYDROCHLORIDE | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE;INJECTION | Prescription | No | AP | 217792 | SOMERSET |
BUPIVACAINE HYDROCHLORIDE | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE;INJECTION | Prescription | No | AP | 091503 | STERISCIENCE SPECLTS |
BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE;INJECTION | Prescription | No | AP | 203895 | EUGIA PHARMA |
BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE;INJECTION | Prescription | No | AP | 204842 | HIKMA PHARMS |
BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE;INJECTION | Prescription | No | AP | 091487 | STERISCIENCE SPECLTS |
MARCAINE HYDROCHLORIDE | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE;INJECTION | Prescription | Yes | AP | 016964 | HOSPIRA |
MARCAINE HYDROCHLORIDE PRESERVATIVE FREE | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE;INJECTION | Prescription | Yes | AP | 016964 | HOSPIRA |
SENSORCAINE | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE;INJECTION | Prescription | Yes | AP | 018304 | FRESENIUS KABI USA |
SENSORCAINE | BUPIVACAINE HYDROCHLORIDE | 0.5% | INJECTABLE;INJECTION | Prescription | No | AP | 070553 | FRESENIUS KABI USA |