Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077273
Company: ECR PHARMA

Products on ANDA 77273

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TUSSICAPS	CHLORPHENIRAMINE POLISTIREX; HYDROCODONE POLISTIREX	EQ 8MG MALEATE;EQ 10MG BITARTRATE	CAPSULE, EXTENDED RELEASE;ORAL	Discontinued	None	No	No
TUSSICAPS	CHLORPHENIRAMINE POLISTIREX; HYDROCODONE POLISTIREX	EQ 4MG MALEATE;EQ 5MG BITARTRATE	CAPSULE, EXTENDED RELEASE;ORAL	Discontinued	None	No	No

Labels for ANDA 077273

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/24/2007	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/077273s000lbl.pdf