BUPIVACAINE HYDROCHLORIDE 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 از شرکت HOSPIRA

Abbreviated New Drug Application (ANDA): 070584

Company: HOSPIRA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BUPIVACAINE HYDROCHLORIDE 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
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-40 Labeling-Package Insert

Label is not available on this site.

07/16/2020 SUPPL-39 Labeling-Package Insert

Label is not available on this site.

07/16/2020 SUPPL-29 Labeling-Package Insert

Label is not available on this site.

08/18/2015 SUPPL-27 Labeling-Package Insert

Label is not available on this site.

04/07/2010 SUPPL-24 Labeling-Package Insert

Label is not available on this site.

10/25/2002 SUPPL-17 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

03/22/2001 SUPPL-16 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

03/22/2001 SUPPL-15 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/02/1999 SUPPL-14 Labeling

Label is not available on this site.

01/07/2000 SUPPL-13 Labeling

Label is not available on this site.

01/07/2000 SUPPL-12 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

10/03/1996 SUPPL-9 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

10/22/1996 SUPPL-8 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

07/07/1995 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

07/06/1995 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

09/25/1990 SUPPL-3 Labeling

Label is not available on this site.

05/07/1990 SUPPL-2 Labeling

Label is not available on this site.

08/23/1989 SUPPL-1 Labeling

Label is not available on this site.

BUPIVACAINE HYDROCHLORIDE

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 207183 AUROBINDO PHARMA LTD
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 018053 HOSPIRA
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 PRESERVATIVE FREE BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE;INJECTION Prescription No AP 203895 AUROBINDO PHARMA LTD
BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE;INJECTION Prescription No AP 204842 HIKMA PHARMS
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 No AP 018304 FRESENIUS KABI USA
SENSORCAINE BUPIVACAINE HYDROCHLORIDE 0.5% INJECTABLE;INJECTION Prescription No AP 070553 FRESENIUS KABI USA
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