Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 084048
Company: SEPTODONT

Products on ANDA 084048

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
OCTOCAINE	EPINEPHRINE; LIDOCAINE HYDROCHLORIDE	0.01MG/ML;2%	INJECTABLE;INJECTION	Discontinued	None	No	No
OCTOCAINE	EPINEPHRINE; LIDOCAINE HYDROCHLORIDE	0.02MG/ML;2%	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 084048

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/09/1980	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
08/02/1999	SUPPL-24	Manufacturing (CMC)-Facility		Label is not available on this site.
12/10/1998	SUPPL-23	Manufacturing (CMC)		Label is not available on this site.
04/08/1998	SUPPL-22	Labeling		Label is not available on this site.
01/14/1992	SUPPL-21	Labeling		Label is not available on this site.
01/14/1992	SUPPL-20	Labeling		Label is not available on this site.
01/26/1993	SUPPL-19	Manufacturing (CMC)		Label is not available on this site.
06/29/1990	SUPPL-17	Labeling		Label is not available on this site.
06/29/1990	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
06/29/1990	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
06/29/1990	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
01/10/1984	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
04/12/1983	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
07/15/1982	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.