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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090891
Company: LYNE

Products on ANDA 090891

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DEXAMETHASONE	DEXAMETHASONE	0.5MG/5ML	ELIXIR;ORAL	Prescription	AA	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 090891

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/12/2011	ORIG-1	Approval				Label is not available on this site.

Therapeutic Equivalents for ANDA 090891

DEXAMETHASONE

ELIXIR;ORAL; 0.5MG/5ML
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DEXAMETHASONE	DEXAMETHASONE	0.5MG/5ML	ELIXIR;ORAL	Prescription	No	AA	084754	ANIMA
DEXAMETHASONE	DEXAMETHASONE	0.5MG/5ML	ELIXIR;ORAL	Prescription	No	AA	091188	CHARTWELL MOLECULAR
DEXAMETHASONE	DEXAMETHASONE	0.5MG/5ML	ELIXIR;ORAL	Prescription	No	AA	090891	LYNE

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