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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 070585
Company: HOSPIRA

Products on ANDA 070585

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BUPIVACAINE HYDROCHLORIDE	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 070585

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/03/1987	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-41	Labeling-Package Insert		Label is not available on this site.
12/09/2020	SUPPL-40	Labeling-Package Insert		Label is not available on this site.
12/09/2020	SUPPL-30	Labeling-Package Insert		Label is not available on this site.
08/18/2015	SUPPL-28	Labeling-Package Insert		Label is not available on this site.
04/07/2010	SUPPL-25	Labeling-Package Insert		Label is not available on this site.
01/27/2005	SUPPL-18	Labeling		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.
09/22/1995	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
09/25/1990	SUPPL-4	Labeling		Label is not available on this site.
05/07/1990	SUPPL-3	Labeling		Label is not available on this site.
08/23/1989	SUPPL-2	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 070585

BUPIVACAINE HYDROCHLORIDE

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	217821	ASPIRO
BUPIVACAINE HYDROCHLORIDE	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE;INJECTION	Prescription	No	AP	070585	HOSPIRA
BUPIVACAINE HYDROCHLORIDE	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE;INJECTION	Prescription	No	AP	216040	KINDOS
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
BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE;INJECTION	Prescription	No	AP	091487	STERISCIENCE
MARCAINE HYDROCHLORIDE PRESERVATIVE FREE	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE;INJECTION	Prescription	Yes	AP	016964	HOSPIRA
SENSORCAINE	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE;INJECTION	Prescription	Yes	AP	018304	FRESENIUS KABI USA
SENSORCAINE	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE;INJECTION	Prescription	No	AP	070554	FRESENIUS KABI USA

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