Drugs@FDA: FDA-Approved Drugs
Company: HOSPIRA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
BUPIVACAINE HYDROCHLORIDE | BUPIVACAINE HYDROCHLORIDE | 0.25% | 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 |
---|---|---|---|---|---|---|---|
02/17/1987 | 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 |
---|---|---|---|---|---|
07/06/2021 | SUPPL-37 | Labeling-Package Insert |
Label is not available on this site. |
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12/09/2020 | SUPPL-36 | Labeling-Package Insert |
Label is not available on this site. |
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12/09/2020 | SUPPL-26 | Labeling-Package Insert |
Label is not available on this site. |
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08/18/2015 | SUPPL-24 | Labeling-Package Insert |
Label is not available on this site. |
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04/07/2010 | SUPPL-21 | Labeling-Package Insert |
Label is not available on this site. |
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10/25/2002 | SUPPL-13 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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11/02/1999 | SUPPL-12 | Labeling |
Label is not available on this site. |
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05/05/1998 | SUPPL-10 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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10/03/1996 | SUPPL-8 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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09/21/1995 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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03/11/1991 | SUPPL-3 | Labeling |
Label is not available on this site. |
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05/07/1990 | SUPPL-2 | Labeling |
Label is not available on this site. |
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12/28/1989 | SUPPL-1 | Labeling |
Label is not available on this site. |
BUPIVACAINE HYDROCHLORIDE
INJECTABLE;INJECTION; 0.25%
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
BUPIVACAINE HYDROCHLORIDE | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE;INJECTION | Prescription | No | AP | 217821 | ASPIRO |
BUPIVACAINE HYDROCHLORIDE | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE;INJECTION | Prescription | No | AP | 207183 | EUGIA PHARMA |
BUPIVACAINE HYDROCHLORIDE | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE;INJECTION | Prescription | No | AP | 205141 | HIKMA PHARMS |
BUPIVACAINE HYDROCHLORIDE | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE;INJECTION | Prescription | No | AP | 070583 | HOSPIRA |
BUPIVACAINE HYDROCHLORIDE | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE;INJECTION | Prescription | No | AP | 070590 | HOSPIRA |
BUPIVACAINE HYDROCHLORIDE | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE;INJECTION | Prescription | No | AP | 216039 | MEITHEAL |
BUPIVACAINE HYDROCHLORIDE | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE;INJECTION | Prescription | No | AP | 216040 | MEITHEAL |
BUPIVACAINE HYDROCHLORIDE | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE;INJECTION | Prescription | No | AP | 217792 | SOMERSET |
BUPIVACAINE HYDROCHLORIDE | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE;INJECTION | Prescription | No | AP | 091503 | STERISCIENCE SPECLTS |
BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE;INJECTION | Prescription | No | AP | 203895 | EUGIA PHARMA |
BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE;INJECTION | Prescription | No | AP | 204842 | HIKMA PHARMS |
BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE;INJECTION | Prescription | No | AP | 091487 | STERISCIENCE SPECLTS |
MARCAINE HYDROCHLORIDE | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE;INJECTION | Prescription | Yes | AP | 016964 | HOSPIRA |
MARCAINE HYDROCHLORIDE PRESERVATIVE FREE | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE;INJECTION | Prescription | Yes | AP | 016964 | HOSPIRA |
SENSORCAINE | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE;INJECTION | Prescription | Yes | AP | 018304 | FRESENIUS KABI USA |
SENSORCAINE | BUPIVACAINE HYDROCHLORIDE | 0.25% | INJECTABLE;INJECTION | Prescription | No | AP | 070552 | FRESENIUS KABI USA |