Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078959
Company: SEPTODONT INC

Products on ANDA 078959

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PRILOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE	EPINEPHRINE BITARTRATE; PRILOCAINE HYDROCHLORIDE	0.005MG/ML;4%	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 078959

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/30/2011	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
11/26/2019	SUPPL-6	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 078959

PRILOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE

INJECTABLE;INJECTION; 0.005MG/ML;4%
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CITANEST FORTE DENTAL	EPINEPHRINE BITARTRATE; PRILOCAINE HYDROCHLORIDE	0.005MG/ML;4%	INJECTABLE;INJECTION	Prescription	Yes	AP	021383	DENTSPLY PHARM
PRILOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE	EPINEPHRINE BITARTRATE; PRILOCAINE HYDROCHLORIDE	0.005MG/ML;4%	INJECTABLE;INJECTION	Prescription	No	AP	078959	SEPTODONT INC