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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 071168
Company: HOSPIRA

Products on ANDA 071168

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE	BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE	0.5%;0.005MG/ML	INJECTABLE;INJECTION	Prescription	AP	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 071168

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/16/1988	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-42	Labeling-Package Insert		Label is not available on this site.
12/09/2020	SUPPL-38	Labeling-Package Insert		Label is not available on this site.
12/09/2020	SUPPL-31	Labeling-Package Insert		Label is not available on this site.
12/09/2020	SUPPL-29	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
02/19/2010	SUPPL-20	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/071168s020lbl.pdf
12/20/2002	SUPPL-10	Manufacturing (CMC)-Expiration Date		Label is not available on this site.
11/22/1999	SUPPL-9	Labeling		Label is not available on this site.
07/29/1997	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
09/26/1997	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
10/03/1990	SUPPL-5	Labeling		Label is not available on this site.
05/04/1990	SUPPL-4	Labeling		Label is not available on this site.
02/21/1991	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
02/21/1991	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
02/21/1991	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for ANDA 071168

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/19/2010	SUPPL-20	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/071168s020lbl.pdf

Therapeutic Equivalents for ANDA 071168

BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE

INJECTABLE;INJECTION; 0.5%;0.005MG/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE	BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE	0.5%;0.005MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	071168	HOSPIRA
BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE	BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE	0.5%;0.005MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	071170	HOSPIRA

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