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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 205658
Company: MAYNE PHARMA INC

Products on ANDA 205658

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 205658

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/17/2015	ORIG-1	Approval		STANDARD		Label is not available on this site.

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