Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 084578
Company: LANNETT

Products on ANDA 084578

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LANOPHYLLIN	THEOPHYLLINE	80MG/15ML	ELIXIR;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 084578

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/26/1976	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
02/05/1991	SUPPL-4	Labeling		Label is not available on this site.