Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 080925
Company: SEPTODONT

Products on ANDA 080925

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ISOCAINE HYDROCHLORIDE	MEPIVACAINE HYDROCHLORIDE	3%	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 080925

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/17/1972	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-23	Manufacturing (CMC)-Facility		Label is not available on this site.
04/19/1993	SUPPL-22	Labeling		Label is not available on this site.
03/11/1993	SUPPL-21	Manufacturing (CMC)		Label is not available on this site.
01/26/1993	SUPPL-20	Manufacturing (CMC)		Label is not available on this site.
03/11/1993	SUPPL-19	Manufacturing (CMC)		Label is not available on this site.
05/05/1992	SUPPL-17	Labeling		Label is not available on this site.
09/20/1990	SUPPL-16	Labeling		Label is not available on this site.
05/16/1991	SUPPL-14	Labeling		Label is not available on this site.
05/16/1991	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
11/07/1983	SUPPL-12	Labeling		Label is not available on this site.
10/10/1984	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
06/16/1983	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
10/25/1982	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
08/09/1982	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
05/13/1982	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.