Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075103
Company: ALPHARMA US PHARMS

Products on ANDA 075103

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CODAMINE	HYDROCODONE BITARTRATE; PHENYLPROPANOLAMINE HYDROCHLORIDE	5MG/5ML;25MG/5ML	SYRUP;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075103

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/29/2000	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75103ltr.pdf