Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 070967
Company: FRESENIUS KABI USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SENSORCAINE BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE 0.25%;0.0091MG/ML 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
10/13/1987 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
09/01/2015 SUPPL-25 Labeling-Package Insert

Label is not available on this site.

05/19/2010 SUPPL-19 Labeling-Package Insert

Label is not available on this site.

03/08/2002 SUPPL-16 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

06/08/2001 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

05/21/2001 SUPPL-14 Labeling

Label is not available on this site.

08/25/1997 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

04/14/1997 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

05/31/1996 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

09/11/1992 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

03/10/1993 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

05/13/1992 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

08/27/1991 SUPPL-4 Labeling

Label is not available on this site.

12/03/1991 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

12/03/1991 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

11/10/1987 SUPPL-1 Labeling

Label is not available on this site.

SENSORCAINE

INJECTABLE;INJECTION; 0.25%;0.0091MG/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MARCAINE HYDROCHLORIDE W/ EPINEPHRINE BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE 0.25%;0.0091MG/ML INJECTABLE;INJECTION Prescription Yes AP 016964 HOSPIRA
MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE 0.25%;0.0091MG/ML INJECTABLE;INJECTION Prescription Yes AP 016964 HOSPIRA
SENSORCAINE BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE 0.25%;0.0091MG/ML INJECTABLE;INJECTION Prescription No AP 070966 FRESENIUS KABI USA
SENSORCAINE BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE 0.25%;0.0091MG/ML INJECTABLE;INJECTION Prescription No AP 070967 FRESENIUS KABI USA

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