Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 070583
Company: HOSPIRA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BUPIVACAINE HYDROCHLORIDE BUPIVACAINE HYDROCHLORIDE 0.25% 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
02/17/1987 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
07/16/2020 SUPPL-40 Labeling-Package Insert

Label is not available on this site.

07/16/2020 SUPPL-30 Labeling-Package Insert

Label is not available on this site.

08/18/2015 SUPPL-27 Labeling-Package Insert

Label is not available on this site.

04/07/2010 SUPPL-24 Labeling-Package Insert

Label is not available on this site.

02/23/2005 SUPPL-17 Labeling

Label is not available on this site.

10/25/2002 SUPPL-16 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

03/22/2001 SUPPL-15 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

03/22/2001 SUPPL-14 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/02/1999 SUPPL-13 Labeling

Label is not available on this site.

01/07/2000 SUPPL-12 Labeling

Label is not available on this site.

01/07/2000 SUPPL-11 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

10/03/1996 SUPPL-8 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

10/22/1996 SUPPL-7 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

09/21/1995 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

09/25/1990 SUPPL-3 Labeling

Label is not available on this site.

05/07/1990 SUPPL-2 Labeling

Label is not available on this site.

08/23/1989 SUPPL-1 Labeling

Label is not available on this site.

BUPIVACAINE HYDROCHLORIDE

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 AUROBINDO PHARMA LTD
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 AUROBINDO PHARMA LTD
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

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