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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 217821
Company: ASPIRO

Products on ANDA 217821

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
BUPIVACAINE HYDROCHLORIDE	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE;INJECTION	Prescription	AP	No	No
BUPIVACAINE HYDROCHLORIDE	BUPIVACAINE HYDROCHLORIDE	0.75%	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 217821

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/27/2024	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 217821

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

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	217821	ASPIRO
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	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	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE;INJECTION	Prescription	No	AP	216039	MEITHEAL
BUPIVACAINE HYDROCHLORIDE	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE;INJECTION	Prescription	No	AP	216040	MEITHEAL
BUPIVACAINE HYDROCHLORIDE	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE;INJECTION	Prescription	No	AP	217792	SOMERSET
BUPIVACAINE HYDROCHLORIDE	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE;INJECTION	Prescription	No	AP	091503	STERISCIENCE SPECLTS
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
BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE;INJECTION	Prescription	No	AP	091487	STERISCIENCE SPECLTS
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	Yes	AP	018304	FRESENIUS KABI USA
SENSORCAINE	BUPIVACAINE HYDROCHLORIDE	0.5%	INJECTABLE;INJECTION	Prescription	No	AP	070553	FRESENIUS KABI USA

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	MEITHEAL
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 SPECLTS
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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