BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE از شرکت HOSPIRA

اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است

BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE از شرکت HOSPIRA

Abbreviated New Drug Application (ANDA): 071165

Company: HOSPIRA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE 0.25%;0.005MG/ML INJECTABLE;INJECTION Prescription

None

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.

07/16/2020 SUPPL-38 Labeling-Package Insert

Label is not available on this site.

08/20/2015 SUPPL-30 Labeling-Container/Carton Labels

Label is not available on this site.

08/20/2015 SUPPL-28 Labeling-Package Insert

Label is not available on this site.

02/19/2010 SUPPL-20 Labeling-Package Insert

Label (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/071165s020lbl.pdf

12/20/2002 SUPPL-10 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

11/22/1999 SUPPL-9 Labeling

Label is not available on this site.

09/26/1997 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

10/03/1990 SUPPL-5 Labeling

Label is not available on this site.

05/04/1990 SUPPL-4 Labeling

Label is not available on this site.

02/21/1991 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

02/21/1991 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

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/2010/071165s020lbl.pdf
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