Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 073580
Company: IMPAX LABS INC

Products on ANDA 073580

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
EMVERM	MEBENDAZOLE	100MG	TABLET, CHEWABLE;ORAL	Prescription	None	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 073580

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/04/1995	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
07/21/2015	SUPPL-25	Labeling-Package Insert		Label is not available on this site.
11/20/2002	SUPPL-14	Manufacturing (CMC)-Facility		Label is not available on this site.
11/20/2002	SUPPL-13	Manufacturing (CMC)-Facility		Label is not available on this site.
10/31/2001	SUPPL-12	Manufacturing (CMC)-Facility		Label is not available on this site.
10/31/2001	SUPPL-11	Manufacturing (CMC)-Facility		Label is not available on this site.
10/31/2001	SUPPL-10	Manufacturing (CMC)-Facility		Label is not available on this site.
01/23/2002	SUPPL-9	Manufacturing (CMC)-Facility		Label is not available on this site.
02/26/2001	SUPPL-8	Manufacturing (CMC)-Facility		Label is not available on this site.
03/23/1999	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
01/25/1999	SUPPL-6	Labeling		Label is not available on this site.
06/11/1998	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
02/03/1998	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
02/03/1998	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
05/31/1996	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
05/26/1995	SUPPL-1	Labeling		Label is not available on this site.