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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040419
Company: SPECGX LLC

REMS

Products on ANDA 40419

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ACETAMINOPHEN AND CODEINE PHOSPHATE	ACETAMINOPHEN; CODEINE PHOSPHATE	300MG;15MG	TABLET;ORAL	Prescription	AA	No	Yes
ACETAMINOPHEN AND CODEINE PHOSPHATE	ACETAMINOPHEN; CODEINE PHOSPHATE	300MG;30MG	TABLET;ORAL	Prescription	AA	No	Yes
ACETAMINOPHEN AND CODEINE PHOSPHATE	ACETAMINOPHEN; CODEINE PHOSPHATE	300MG;60MG	TABLET;ORAL	Prescription	AA	No	No

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