Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 070584
Company: HOSPIRA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BUPIVACAINE HYDROCHLORIDE 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
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-40 Labeling-Package Insert

Label is not available on this site.

07/16/2020 SUPPL-39 Labeling-Package Insert

Label is not available on this site.

07/16/2020 SUPPL-29 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.

10/25/2002 SUPPL-17 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

03/22/2001 SUPPL-16 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

03/22/2001 SUPPL-15 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/02/1999 SUPPL-14 Labeling

Label is not available on this site.

01/07/2000 SUPPL-13 Labeling

Label is not available on this site.

01/07/2000 SUPPL-12 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

10/03/1996 SUPPL-9 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

10/22/1996 SUPPL-8 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

07/07/1995 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

07/06/1995 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; 0.5%
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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English