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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 070590
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
07/06/2021 SUPPL-37 Labeling-Package Insert

Label is not available on this site.

12/09/2020 SUPPL-36 Labeling-Package Insert

Label is not available on this site.

12/09/2020 SUPPL-26 Labeling-Package Insert

Label is not available on this site.

08/18/2015 SUPPL-24 Labeling-Package Insert

Label is not available on this site.

04/07/2010 SUPPL-21 Labeling-Package Insert

Label is not available on this site.

10/25/2002 SUPPL-13 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

11/02/1999 SUPPL-12 Labeling

Label is not available on this site.

05/05/1998 SUPPL-10 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.

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

Label is not available on this site.

03/11/1991 SUPPL-3 Labeling

Label is not available on this site.

05/07/1990 SUPPL-2 Labeling

Label is not available on this site.

12/28/1989 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 217821 ASPIRO
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 070583 HOSPIRA
BUPIVACAINE HYDROCHLORIDE BUPIVACAINE HYDROCHLORIDE 0.25% INJECTABLE;INJECTION Prescription No AP 070590 HOSPIRA
BUPIVACAINE HYDROCHLORIDE BUPIVACAINE HYDROCHLORIDE 0.25% INJECTABLE;INJECTION Prescription No AP 216039 MEITHEAL
BUPIVACAINE HYDROCHLORIDE BUPIVACAINE HYDROCHLORIDE 0.25% INJECTABLE;INJECTION Prescription No AP 216040 MEITHEAL
BUPIVACAINE HYDROCHLORIDE BUPIVACAINE HYDROCHLORIDE 0.25% INJECTABLE;INJECTION Prescription No AP 217792 SOMERSET
BUPIVACAINE HYDROCHLORIDE BUPIVACAINE HYDROCHLORIDE 0.25% INJECTABLE;INJECTION Prescription No AP 091503 STERISCIENCE SPECLTS
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
BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE BUPIVACAINE HYDROCHLORIDE 0.25% INJECTABLE;INJECTION Prescription No AP 091487 STERISCIENCE SPECLTS
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 Yes AP 018304 FRESENIUS KABI USA
SENSORCAINE BUPIVACAINE HYDROCHLORIDE 0.25% INJECTABLE;INJECTION Prescription No AP 070552 FRESENIUS KABI USA
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