Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040701
Company: BOCA PHARMA LLC

• Safety Labeling Change Order Letter

Products on ANDA 040701

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BITARTRATE	ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE	712.8MG;60MG;32MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040701

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/03/2007	ORIG-1	Approval				Label is not available on this site.