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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 084614
Company: ROXANE

Products on ANDA 084614

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DEXAMETHASONE	DEXAMETHASONE	0.25MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 084614

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/14/1985	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
11/02/1983	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.

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