Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 214348
Company: HENGRUI PHARMA

Products on ANDA 214348

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BUPIVACAINE LIPOSOME	BUPIVACAINE	133MG/10ML (13.3MG/ML)	INJECTABLE, LIPOSOMAL;INJECTION	Prescription	AP	No	No
BUPIVACAINE LIPOSOME	BUPIVACAINE	266MG/20ML (13.3MG/ML)	INJECTABLE, LIPOSOMAL;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 214348

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/01/2024	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/214348Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 214348

BUPIVACAINE LIPOSOME

INJECTABLE, LIPOSOMAL;INJECTION; 133MG/10ML (13.3MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BUPIVACAINE LIPOSOME	BUPIVACAINE	133MG/10ML (13.3MG/ML)	INJECTABLE, LIPOSOMAL;INJECTION	Prescription	No	AP	214348	HENGRUI PHARMA
EXPAREL	BUPIVACAINE	133MG/10ML (13.3MG/ML)	INJECTABLE, LIPOSOMAL;INJECTION	Prescription	Yes	AP	022496	PACIRA PHARMS INC

INJECTABLE, LIPOSOMAL;INJECTION; 266MG/20ML (13.3MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BUPIVACAINE LIPOSOME	BUPIVACAINE	266MG/20ML (13.3MG/ML)	INJECTABLE, LIPOSOMAL;INJECTION	Prescription	No	AP	214348	HENGRUI PHARMA
EXPAREL	BUPIVACAINE	266MG/20ML (13.3MG/ML)	INJECTABLE, LIPOSOMAL;INJECTION	Prescription	Yes	AP	022496	PACIRA PHARMS INC