Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 088388
Company: DEPROCO

Products on ANDA 088388

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SCANDONEST L	LEVONORDEFRIN; MEPIVACAINE HYDROCHLORIDE	0.05MG/ML;2%	INJECTABLE;INJECTION	Prescription	None	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 088388

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/10/1984	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
11/02/2018	SUPPL-38	Labeling-Package Insert		Label is not available on this site.
09/12/2008	SUPPL-30	Labeling		Label is not available on this site.
06/18/2007	SUPPL-29	Labeling		Label is not available on this site.
10/12/2004	SUPPL-27	Labeling		Label is not available on this site.
04/06/2000	SUPPL-20	Manufacturing (CMC)-Packaging		Label is not available on this site.
04/06/2000	SUPPL-19	Manufacturing (CMC)-Manufacturing Process		Label is not available on this site.
03/04/1996	SUPPL-16	Labeling		Label is not available on this site.
08/04/1994	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
09/16/1993	SUPPL-14	Labeling		Label is not available on this site.
05/12/1992	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
02/07/1992	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
05/05/1988	SUPPL-8	Labeling		Label is not available on this site.
06/22/1987	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
04/08/1987	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
01/14/1986	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
09/16/1985	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.