Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 070554
Company: FRESENIUS KABI USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SENSORCAINE 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
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-28 Labeling-Package Insert

Label is not available on this site.

05/17/2010 SUPPL-21 Labeling-Package Insert

Label is not available on this site.

03/08/2002 SUPPL-19 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

06/08/2001 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

05/21/2001 SUPPL-17 Labeling

Label is not available on this site.

08/25/1997 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

05/31/1996 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

06/26/1996 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

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

Label is not available on this site.

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

Label is not available on this site.

05/12/1992 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

12/18/1990 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

09/03/1991 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

09/03/1991 SUPPL-5 Labeling

Label is not available on this site.

11/10/1987 SUPPL-4 Labeling

Label is not available on this site.

10/14/1987 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

10/14/1987 SUPPL-2 Labeling

Label is not available on this site.

10/14/1987 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

SENSORCAINE

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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