Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 087185
Company: IVAX PHARMS

Products on ANDA 087185

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
HYDROGENATED ERGOT ALKALOIDS	ERGOLOID MESYLATES	1MG	TABLET;SUBLINGUAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 087185

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/20/1980	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
07/29/2002	SUPPL-32	Manufacturing (CMC)-Facility		Label is not available on this site.
03/12/2002	SUPPL-31	Manufacturing (CMC)-Facility		Label is not available on this site.
06/27/2002	SUPPL-30	Manufacturing (CMC)-Packaging		Label is not available on this site.
07/21/2000	SUPPL-29	Manufacturing (CMC)-Facility		Label is not available on this site.
07/21/2000	SUPPL-28	Manufacturing (CMC)-Facility		Label is not available on this site.
01/28/2000	SUPPL-27	Manufacturing (CMC)-Facility		Label is not available on this site.
11/23/1999	SUPPL-26	Manufacturing (CMC)-Facility		Label is not available on this site.
08/20/1999	SUPPL-25	Manufacturing (CMC)		Label is not available on this site.
12/09/1998	SUPPL-24	Manufacturing (CMC)		Label is not available on this site.
05/30/1997	SUPPL-23	Manufacturing (CMC)		Label is not available on this site.
11/22/1995	SUPPL-22	Manufacturing (CMC)		Label is not available on this site.
08/24/1994	SUPPL-21	Manufacturing (CMC)		Label is not available on this site.
06/27/1995	SUPPL-19	Manufacturing (CMC)		Label is not available on this site.
05/17/1990	SUPPL-18	Labeling		Label is not available on this site.
08/02/1989	SUPPL-17	Labeling		Label is not available on this site.
02/11/1988	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
08/22/1988	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
02/11/1988	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
02/11/1988	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.