Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077802
Company: GLENMARK PHARMS LTD

• Healthcare Professional Sheet

Products on ANDA 77802

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
OXCARBAZEPINE	OXCARBAZEPINE	150MG	TABLET;ORAL	Prescription	AB	No	No
OXCARBAZEPINE	OXCARBAZEPINE	300MG	TABLET;ORAL	Prescription	AB	No	No
OXCARBAZEPINE	OXCARBAZEPINE	600MG	TABLET;ORAL	Prescription	AB	No	No

Labels for ANDA 077802

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/09/2007	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/077802s000lbl.pdf