Drugs@FDA: FDA-Approved Drugs
Company: HOSPIRA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE | BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE | 0.5%;0.005MG/ML | INJECTABLE;INJECTION | Prescription | AP | No | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
06/16/1988 | 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 |
---|---|---|---|---|---|
07/06/2021 | SUPPL-42 | Labeling-Package Insert |
Label is not available on this site. |
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12/09/2020 | SUPPL-38 | Labeling-Package Insert |
Label is not available on this site. |
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12/09/2020 | SUPPL-31 | Labeling-Package Insert |
Label is not available on this site. |
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12/09/2020 | SUPPL-29 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
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02/19/2010 | SUPPL-20 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/071168s020lbl.pdf | |
12/20/2002 | SUPPL-10 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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11/22/1999 | SUPPL-9 | Labeling |
Label is not available on this site. |
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07/29/1997 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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09/26/1997 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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10/03/1990 | SUPPL-5 | Labeling |
Label is not available on this site. |
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05/04/1990 | SUPPL-4 | Labeling |
Label is not available on this site. |
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02/21/1991 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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02/21/1991 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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02/21/1991 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
02/19/2010 | SUPPL-20 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/071168s020lbl.pdf |
BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE
INJECTABLE;INJECTION; 0.5%;0.005MG/ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE | BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE | 0.5%;0.005MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 071168 | HOSPIRA |
BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE | BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE | 0.5%;0.005MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 071170 | HOSPIRA |