What the 2018 label still prints about 2003
| Line on the archived label | What it prints |
|---|---|
| Initial US approval | 2003 |
| Revision of this copy | November 2018 |
| Manufactured for | Bayer HealthCare, Whippany, NJ |
| Manufactured in | Germany |
| Distributed by | GlaxoSmithKline, Research Triangle Park, NC |
The highlights on that archived label read: Levitra (vardenafil hydrochloride) tablets, for oral use, initial US approval 2003. Further down, the package description lists bottles of 30 in 5 mg, 10 mg, and 20 mg. Those are the swallowed film-coated strengths on this label. They are not a timeline of when each strength appeared.
The manufacturer block is the part a history search usually wants and rarely quotes. Manufactured for Bayer HealthCare Pharmaceuticals Inc., Whippany, NJ 07981. Manufactured in Germany. Distributed by GlaxoSmithKline, Research Triangle Park, NC 27709. The trademark sentence sits in the same block: Levitra is a registered trademark of Bayer Pharma AG and is used under license by GlaxoSmithKline. A page that says only Bayer made it has dropped the distributor the label still names.
A 2007 FDA label PDF for Levitra was downloaded with this search. Its text is stored in a form that does not yield a clean approval sentence, so it is not used for the year. The year on this page is the one printed in the 2018-revised highlights.
Three company names, and a 2005 split outside the US
The Wikipedia article on vardenafil, opened 24 October 2026, says vardenafil was co-marketed by Bayer Pharmaceuticals, GlaxoSmithKline, and Schering-Plough under the brand name Levitra. Schering-Plough does not appear in the manufacturer block quoted above. The encyclopedia is the source for that third name. This page does not upgrade it into a line on the 2018 carton.
The same history section says that as of 2005, the co-promotion rights of GSK on Levitra had been returned to Bayer in many markets outside the US. Many markets outside the US is the limit of that sentence. It does not say the US bottle lost the GlaxoSmithKline line. The 2018 label still prints GSK as the distributor.
In Italy, the article says, Bayer sells vardenafil as Levitra and GSK sells it as Vivanza. Because of European Union trade rules, parallel imports might put Vivanza beside Levitra in the EU. That is a naming and trade note. It is not a second US approval, and it is not a different dose.
The melt that is not this tablet
The same Wikipedia section describes an orally disintegrating form, marketed as Staxyn and Levitra Soft, that has been gaining approvals in countries such as the United States and Canada. The opened sources for this page do not give a year for that US approval, so none is stated. Staxyn is not a nickname for the swallowed 5 mg, 10 mg, and 20 mg film tablets. How to time the swallowed tablet is the Levitra timing note. Do not copy that hour, or that dose ladder, onto a tablet that melts on the tongue.
A warning the later label still carries
History is not only the year on the highlights. The same label says patients should stop Levitra and seek medical attention in the event of sudden decrease or loss in hearing. Administration with nitrates and nitric oxide donors is listed as a contraindication. A suitable time interval after a Levitra dose, for the safe administration of nitrates or nitric oxide donors, has not been determined. Those are current instructions on a label whose highlights still point back to 2003. They are not a story about the first advertisement.
What the fixed-dose trials measured, including the difference between a general-population row and a diabetes or prostatectomy row, is the Levitra evidence note. Access checks for the medicine itself are on the vardenafil medicine page.
What a history search does not need from a shop
A results-page title in this search calls Levitra Viagra's first US challenger. The article behind that title did not come back as readable text, so this page does not treat first as a measured fact. Star ratings, coupon pages, and a first-person diary are a different job from the approval line.
Do not start, stop, or change vardenafil from a library page. The useful history is short: approval year 2003 on the US film-tablet label, Bayer as the company it was manufactured for, Germany as the place of manufacture, GlaxoSmithKline as the named distributor, and a later melt under other names that this label does not describe.