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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075945
Company: MYLAN PHARMS INC

Other Important Information from FDA

REMS

Products on ANDA 75945

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AMNESTEEM	ISOTRETINOIN	10MG	CAPSULE;ORAL	Prescription	AB1	No	No
AMNESTEEM	ISOTRETINOIN	20MG	CAPSULE;ORAL	Prescription	AB1	No	No
AMNESTEEM	ISOTRETINOIN	40MG	CAPSULE;ORAL	Prescription	AB1	No	No
AMNESTEEM	ISOTRETINOIN	30MG	CAPSULE;ORAL	Prescription	AB1	No	No

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