Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078830
Company: PADAGIS US

Products on ANDA 78830

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SCOPOLAMINE	SCOPOLAMINE	1MG/72HR	SYSTEM;TRANSDERMAL	Prescription	AB	No	No

Labels for ANDA 078830

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/30/2015	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/078830Orig1s000lbl.pdf