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

New Drug Application (NDA): 018053

Company: HOSPIRA

Drug NameActive IngredientsStrengthDosage Form/RouteMarketing StatusTE CodeRLDRS
BUPIVACAINE HYDROCHLORIDEBUPIVACAINE HYDROCHLORIDE0.5%INJECTABLE;INJECTIONPrescription

AP

NoNo
BUPIVACAINE HYDROCHLORIDEBUPIVACAINE HYDROCHLORIDE0.25%INJECTABLE;INJECTIONPrescription

AP

NoNo
BUPIVACAINE HYDROCHLORIDEBUPIVACAINE HYDROCHLORIDE0.75%INJECTABLE;INJECTIONPrescription

AP

NoNo
Original Approvals or Tentative Approvals
Action DateSubmissionAction TypeSubmission ClassificationReview Priority; Orphan StatusLetters, Reviews, Labels, Patient Package InsertNotesUrl
04/17/1978ORIG-1 Approval

Label is not available on this site.

Supplements
Action DateSubmissionSupplement Categories or Approval TypeLetters, Reviews, Labels, Patient Package InsertNoteUrl
03/09/2021SUPPL-61 Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018053s061lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/018053Orig1s061ltr.pdf

11/02/2018SUPPL-60 Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018053s060lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/018053Orig1s60Ltr.pdf

01/11/2016SUPPL-57 Manufacturing (CMC)

Label is not available on this site.

05/06/2014SUPPL-56 Manufacturing (CMC)

Label is not available on this site.

07/10/2015SUPPL-55 Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018053s055lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/018053Orig1s055ltr.pdf

04/07/2010SUPPL-52 Labeling-Package Insert

Label is not available on this site.

08/29/2002SUPPL-44 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

11/02/1999SUPPL-43 Labeling

Label is not available on this site.

04/07/1999SUPPL-42 Manufacturing (CMC)

Label is not available on this site.

02/24/1997SUPPL-40 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

11/04/1996SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

11/04/1996SUPPL-38 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

12/11/1991SUPPL-36 Labeling

Label is not available on this site.

01/29/1992SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

05/04/1990SUPPL-34 Labeling

Label is not available on this site.

02/15/1991SUPPL-33 Labeling

Label is not available on this site.

04/07/1988SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

Action DateSubmissionSupplement Categories or Approval TypeLetters, Reviews, Labels,
Patient Package Insert
NoteUrl
03/09/2021SUPPL-61

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018053s061lbl.pdf
11/02/2018SUPPL-60

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018053s060lbl.pdf
07/10/2015SUPPL-55

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/018053s055lbl.pdf

BUPIVACAINE HYDROCHLORIDE

INJECTABLE;INJECTION; 0.5%

TE Code = AP

Drug NameActive IngredientsStrengthDosage Form/RouteMarketing StatusRLDTE CodeApplication No.Company
BUPIVACAINE HYDROCHLORIDEBUPIVACAINE HYDROCHLORIDE0.5%INJECTABLE;INJECTIONPrescriptionNoAP207183AUROBINDO PHARMA LTD
BUPIVACAINE HYDROCHLORIDEBUPIVACAINE HYDROCHLORIDE0.5%INJECTABLE;INJECTIONPrescriptionNoAP205141HIKMA PHARMS
BUPIVACAINE HYDROCHLORIDEBUPIVACAINE HYDROCHLORIDE0.5%INJECTABLE;INJECTIONPrescriptionNoAP018053HOSPIRA
BUPIVACAINE HYDROCHLORIDEBUPIVACAINE HYDROCHLORIDE0.5%INJECTABLE;INJECTIONPrescriptionNoAP070584HOSPIRA
BUPIVACAINE HYDROCHLORIDEBUPIVACAINE HYDROCHLORIDE0.5%INJECTABLE;INJECTIONPrescriptionNoAP070597HOSPIRA
BUPIVACAINE HYDROCHLORIDEBUPIVACAINE HYDROCHLORIDE0.5%INJECTABLE;INJECTIONPrescriptionNoAP070609HOSPIRA
BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREEBUPIVACAINE HYDROCHLORIDE0.5%INJECTABLE;INJECTIONPrescriptionNoAP203895AUROBINDO PHARMA LTD
BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREEBUPIVACAINE HYDROCHLORIDE0.5%INJECTABLE;INJECTIONPrescriptionNoAP204842HIKMA PHARMS
MARCAINE HYDROCHLORIDEBUPIVACAINE HYDROCHLORIDE0.5%INJECTABLE;INJECTIONPrescriptionYesAP016964HOSPIRA
MARCAINE HYDROCHLORIDE PRESERVATIVE FREEBUPIVACAINE HYDROCHLORIDE0.5%INJECTABLE;INJECTIONPrescriptionYesAP016964HOSPIRA
SENSORCAINEBUPIVACAINE HYDROCHLORIDE0.5%INJECTABLE;INJECTIONPrescriptionNoAP018304FRESENIUS KABI USA
SENSORCAINEBUPIVACAINE HYDROCHLORIDE0.5%INJECTABLE;INJECTIONPrescriptionNoAP070553FRESENIUS KABI USA

INJECTABLE;INJECTION; 0.25%

TE Code = AP

Drug NameActive IngredientsStrengthDosage Form/RouteMarketing StatusRLDTE CodeApplication No.Company
BUPIVACAINE HYDROCHLORIDEBUPIVACAINE HYDROCHLORIDE0.25%INJECTABLE;INJECTIONPrescriptionNoAP207183AUROBINDO PHARMA LTD
BUPIVACAINE HYDROCHLORIDEBUPIVACAINE HYDROCHLORIDE0.25%INJECTABLE;INJECTIONPrescriptionNoAP205141HIKMA PHARMS
BUPIVACAINE HYDROCHLORIDEBUPIVACAINE HYDROCHLORIDE0.25%INJECTABLE;INJECTIONPrescriptionNoAP018053HOSPIRA
BUPIVACAINE HYDROCHLORIDEBUPIVACAINE HYDROCHLORIDE0.25%INJECTABLE;INJECTIONPrescriptionNoAP070583HOSPIRA
BUPIVACAINE HYDROCHLORIDEBUPIVACAINE HYDROCHLORIDE0.25%INJECTABLE;INJECTIONPrescriptionNoAP070586HOSPIRA
BUPIVACAINE HYDROCHLORIDEBUPIVACAINE HYDROCHLORIDE0.25%INJECTABLE;INJECTIONPrescriptionNoAP070590HOSPIRA
BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREEBUPIVACAINE HYDROCHLORIDE0.25%INJECTABLE;INJECTIONPrescriptionNoAP203895AUROBINDO PHARMA LTD
BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREEBUPIVACAINE HYDROCHLORIDE0.25%INJECTABLE;INJECTIONPrescriptionNoAP204842HIKMA PHARMS
MARCAINE HYDROCHLORIDEBUPIVACAINE HYDROCHLORIDE0.25%INJECTABLE;INJECTIONPrescriptionYesAP016964HOSPIRA
MARCAINE HYDROCHLORIDE PRESERVATIVE FREEBUPIVACAINE HYDROCHLORIDE0.25%INJECTABLE;INJECTIONPrescriptionYesAP016964HOSPIRA
SENSORCAINEBUPIVACAINE HYDROCHLORIDE0.25%INJECTABLE;INJECTIONPrescriptionNoAP018304FRESENIUS KABI USA
SENSORCAINEBUPIVACAINE HYDROCHLORIDE0.25%INJECTABLE;INJECTIONPrescriptionNoAP070552FRESENIUS KABI USA

INJECTABLE;INJECTION; 0.75%

TE Code = AP

Drug NameActive IngredientsStrengthDosage Form/RouteMarketing StatusRLDTE CodeApplication No.Company
BUPIVACAINE HYDROCHLORIDEBUPIVACAINE HYDROCHLORIDE0.75%INJECTABLE;INJECTIONPrescriptionNoAP018053HOSPIRA
BUPIVACAINE HYDROCHLORIDEBUPIVACAINE HYDROCHLORIDE0.75%INJECTABLE;INJECTIONPrescriptionNoAP070585HOSPIRA
BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREEBUPIVACAINE HYDROCHLORIDE0.75%INJECTABLE;INJECTIONPrescriptionNoAP203895AUROBINDO PHARMA LTD
BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREEBUPIVACAINE HYDROCHLORIDE0.75%INJECTABLE;INJECTIONPrescriptionNoAP204842HIKMA PHARMS
MARCAINE HYDROCHLORIDE PRESERVATIVE FREEBUPIVACAINE HYDROCHLORIDE0.75%INJECTABLE;INJECTIONPrescriptionYesAP016964HOSPIRA
SENSORCAINEBUPIVACAINE HYDROCHLORIDE0.75%INJECTABLE;INJECTIONPrescriptionNoAP018304FRESENIUS KABI USA
SENSORCAINEBUPIVACAINE HYDROCHLORIDE0.75%INJECTABLE;INJECTIONPrescriptionNoAP070554FRESENIUS KABI USA
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