Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 089410
Company: FRESENIUS KABI USA

Products on ANDA 089410

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
POLOCAINE	MEPIVACAINE HYDROCHLORIDE	2%	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 089410

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/01/1986	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
06/15/2010	SUPPL-15	Labeling-Package Insert		Label is not available on this site.
05/24/2002	SUPPL-13	Labeling		Label is not available on this site.
03/08/2002	SUPPL-11	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
03/30/2001	SUPPL-10	Manufacturing (CMC)-Control		Label is not available on this site.
09/29/1998	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
04/17/1997	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
04/17/1997	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
05/31/1996	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
09/18/1992	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
03/18/1992	SUPPL-3	Labeling		Label is not available on this site.
02/16/1993	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
06/22/1989	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 089410

POLOCAINE

INJECTABLE;INJECTION; 2%
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CARBOCAINE	MEPIVACAINE HYDROCHLORIDE	2%	INJECTABLE;INJECTION	Prescription	Yes	AP	012250	HOSPIRA
POLOCAINE	MEPIVACAINE HYDROCHLORIDE	2%	INJECTABLE;INJECTION	Prescription	No	AP	089410	FRESENIUS KABI USA
POLOCAINE-MPF	MEPIVACAINE HYDROCHLORIDE	2%	INJECTABLE;INJECTION	Prescription	No	AP	089409	FRESENIUS KABI USA