Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 205657
Company: MAYNE PHARMA INC

Products on ANDA 205657

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE	CHLORPHENIRAMINE MALEATE; HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE	4MG/5ML;5MG/5ML;60MG/5ML	SOLUTION;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 205657

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/03/2015	ORIG-1	Approval		STANDARD		Label is not available on this site.