Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019545
Company: MGI PHARMA INC

Products on NDA 019545

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DIDRONEL	ETIDRONATE DISODIUM	50MG/ML	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019545

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/20/1987	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD; Orphan		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/26/2002	SUPPL-6	Manufacturing (CMC)-Control		Label is not available on this site.
09/22/1998	SUPPL-5	Labeling		Label is not available on this site.
04/01/1998	SUPPL-4	Labeling		Label is not available on this site.
09/28/1993	SUPPL-3	Labeling		Label is not available on this site.
07/21/1992	SUPPL-2	Manufacturing (CMC)-Packaging		Label is not available on this site.
01/28/1992	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.