Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 075800
Company: MYLAN

• Other Important Information from FDA

Products on ANDA 075800

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ETIDRONATE DISODIUM	ETIDRONATE DISODIUM	200MG	TABLET;ORAL	Discontinued	None	No	No
ETIDRONATE DISODIUM	ETIDRONATE DISODIUM	400MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075800

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/24/2003	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
07/15/2015	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
07/15/2015	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
02/19/2010	SUPPL-7	Labeling-Container/Carton Labels		Label is not available on this site.
08/29/2006	SUPPL-5	Labeling		Label is not available on this site.
04/05/2005	SUPPL-2	Labeling		Label is not available on this site.