Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 070553
Company: FRESENIUS KABI USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SENSORCAINE 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
05/21/1986 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
09/01/2015 SUPPL-22 Labeling-Package Insert

Label is not available on this site.

05/17/2010 SUPPL-17 Labeling-Package Insert

Label is not available on this site.

03/08/2002 SUPPL-15 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

06/08/2001 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

05/21/2001 SUPPL-13 Labeling

Label is not available on this site.

08/25/1997 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

09/27/1996 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

05/31/1996 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

09/11/1992 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

03/10/1993 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

05/12/1992 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

12/18/1990 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

09/03/1991 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

09/03/1991 SUPPL-1 Labeling

Label is not available on this site.

SENSORCAINE

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

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