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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 089409
Company: FRESENIUS KABI USA

Products on ANDA 089409

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 089409

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
01/29/2025	SUPPL-26	Labeling-Package Insert		Label is not available on this site.
01/29/2025	SUPPL-21	Labeling-Package Insert		Label is not available on this site.
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.
03/21/2000	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
11/26/1996	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
05/31/1996	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
12/27/1994	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.

Therapeutic Equivalents for ANDA 089409

POLOCAINE-MPF

INJECTABLE;INJECTION; 2%
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
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

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