Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 088764
Company: CHARTWELL RX

Products on ANDA 88764

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PROMETH VC W/ CODEINE	CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE	10MG/5ML;5MG/5ML;6.25MG/5ML	SYRUP;ORAL	Discontinued	None	No	No

Labels for ANDA 088764

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/10/2013	SUPPL-84	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/088764Orig1s084lbl.pdf