Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018240
Company: TWI PHARMS

Products on NDA 18240

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TENORMIN	ATENOLOL	50MG	TABLET;ORAL	Prescription	AB	Yes	No
TENORMIN	ATENOLOL	100MG	TABLET;ORAL	Prescription	AB	Yes	Yes
TENORMIN	ATENOLOL	25MG	TABLET;ORAL	Prescription	AB	Yes	No

Labels for NDA 018240

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/22/2023	SUPPL-47	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/018240s047lbl.pdf
10/31/2012	SUPPL-32	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018240s032lbl.pdf
08/17/2011	SUPPL-31	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018240s031lbl.pdf