Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018053
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
BUPIVACAINE HYDROCHLORIDE BUPIVACAINE HYDROCHLORIDE 0.25% INJECTABLE;INJECTION Prescription AP No No
BUPIVACAINE HYDROCHLORIDE BUPIVACAINE HYDROCHLORIDE 0.75% 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
04/17/1978 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
03/09/2021 SUPPL-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
11/02/2018 SUPPL-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
01/11/2016 SUPPL-57 Manufacturing (CMC)

Label is not available on this site.

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

Label is not available on this site.

07/10/2015 SUPPL-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
04/07/2010 SUPPL-52 Labeling-Package Insert

Label is not available on this site.

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

Label is not available on this site.

11/02/1999 SUPPL-43 Labeling

Label is not available on this site.

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

Label is not available on this site.

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

Label is not available on this site.

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

Label is not available on this site.

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

Label is not available on this site.

12/11/1991 SUPPL-36 Labeling

Label is not available on this site.

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

Label is not available on this site.

05/04/1990 SUPPL-34 Labeling

Label is not available on this site.

02/15/1991 SUPPL-33 Labeling

Label is not available on this site.

04/07/1988 SUPPL-31 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
03/09/2021 SUPPL-61 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/018053s061lbl.pdf
11/02/2018 SUPPL-60 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018053s060lbl.pdf
07/10/2015 SUPPL-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 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 EUGIA PHARMA
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 EUGIA PHARMA
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

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 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 018053 HOSPIRA
BUPIVACAINE HYDROCHLORIDE BUPIVACAINE HYDROCHLORIDE 0.25% INJECTABLE;INJECTION Prescription No AP 070583 HOSPIRA
BUPIVACAINE HYDROCHLORIDE BUPIVACAINE HYDROCHLORIDE 0.25% INJECTABLE;INJECTION Prescription No AP 070586 HOSPIRA
BUPIVACAINE HYDROCHLORIDE BUPIVACAINE HYDROCHLORIDE 0.25% INJECTABLE;INJECTION Prescription No AP 070590 HOSPIRA
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
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 No AP 018304 FRESENIUS KABI USA
SENSORCAINE BUPIVACAINE HYDROCHLORIDE 0.25% INJECTABLE;INJECTION Prescription No AP 070552 FRESENIUS KABI USA

INJECTABLE;INJECTION; 0.75%
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BUPIVACAINE HYDROCHLORIDE BUPIVACAINE HYDROCHLORIDE 0.75% INJECTABLE;INJECTION Prescription No AP 018053 HOSPIRA
BUPIVACAINE HYDROCHLORIDE BUPIVACAINE HYDROCHLORIDE 0.75% INJECTABLE;INJECTION Prescription No AP 070585 HOSPIRA
BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE BUPIVACAINE HYDROCHLORIDE 0.75% INJECTABLE;INJECTION Prescription No AP 203895 EUGIA PHARMA
BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE BUPIVACAINE HYDROCHLORIDE 0.75% INJECTABLE;INJECTION Prescription No AP 204842 HIKMA PHARMS
MARCAINE HYDROCHLORIDE PRESERVATIVE FREE BUPIVACAINE HYDROCHLORIDE 0.75% INJECTABLE;INJECTION Prescription Yes AP 016964 HOSPIRA
SENSORCAINE BUPIVACAINE HYDROCHLORIDE 0.75% INJECTABLE;INJECTION Prescription No AP 018304 FRESENIUS KABI USA
SENSORCAINE BUPIVACAINE HYDROCHLORIDE 0.75% INJECTABLE;INJECTION Prescription No AP 070554 FRESENIUS KABI USA

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