It’s one of several medications for ED.
| Medication | Active Ingredient | Onset of Action | Duration | Typical Dose | Cost |
|---|---|---|---|---|---|
| Vardenafil (Levitra) | Vardenafil | 25-60 min | Up to 5 hours | 10 mg | Moderate |
| Sildenafil (Viagra) | Sildenafil | 30-60 min | 4-6 hours | 50 mg | Moderate |
| Tadalafil (Cialis) | Tadalafil | 30-60 min | Up to 36 hours | 10-20 mg | Higher |
Others include sildenafil (the active ingredient
in Viagra), tadalafil (Cialis), and avanafil (Stendra).
Daniel Ritterbeck, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. Section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)) allows the submission of an ANDA to market a generic version of a previously approved drug product. To obtain approval, the ANDA applicant must show, among other things, that the generic drug product: (1) has the same active ingredient(s), dosage form, route of administration, strength, conditions of use, and (with certain exceptions) labeling as the listed drug, which is a version of the drug that was previously approved, and (2) is bioequivalent to the listed drug. ANDA applicants do not have to repeat the extensive clinical testing otherwise necessary to gain approval of a new drug application (NDA).
Section 505(j)(7) of the FD&C Act requires FDA to publish a list of all approved drugs. FDA publishes this list as part of the “Approved Drug Products With Therapeutic Equivalence Evaluations,” which is known generally as the “Orange Book.” Under FDA regulations, drugs are removed from the list if the Agency withdraws or suspends approval of the drug's NDA or ANDA for reasons of safety or effectiveness or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162). A person may petition the Agency to determine, or the Agency may determine on its own initiative, whether a listed drug was withdrawn from sale for reasons of safety or effectiveness. This determination may be made levitra for ed at any time after the drug has been withdrawn from sale, but must be made prior to approving an ANDA that refers to the listed drug (§ 314.161 (21 CFR 314.161)). FDA may not approve an ANDA that does not refer to a listed drug.
Levitra (vardenafil hydrochloride) oral tablets, 5 mg, 10 mg and 20 mg, are ( printed page 27902) the subject of NDA 021400, held by Bayer HealthCare Pharmaceuticals, Inc., and initially approved on August 19, 2003. Levitra is a phosphodiesterase 5 inhibitor indicated for the treatment of erectile dysfunction. In letters dated September 26, 2019, September 24, 2020, and September 20, 2021, Bayer HealthCare Pharmaceuticals, Inc. notified FDA that Levitra (vardenafil hydrochloride) oral tablets, 5 mg, 10 mg and 20 mg, respectively, were being discontinued, and FDA moved the drug products to the “Discontinued Drug Product List” section of the Orange Book. Respira Therapeutics, Inc. Vardenafil is available as 2.5mg, 5mg,
| Product | Dosage | Quantity + Bonus | Price | |
|---|---|---|---|---|
| Levitra Soft Tabs | 20mg | 360 + 20 Pills | 682.21€ 649.72€ | |
| Levitra Original | 20mg | 34 + 2 Pills | 188.51€ 179.53€ | |
| Levitra Professional | 20mg | 120 + 4 Pills | 348.44€ 331.85€ | |
| Levitra Generic | 20mg | 120 + 10 Pills | 224.15€ 213.48€ | |
| Levitra Generic | 10mg | 270 + 10 Pills | 338.09€ 321.99€ | |
| Levitra Generic | 40mg | 10 Pills | 41.37€ 39.40€ | |
| Levitra Generic | 10mg | 30 + 4 Pills | 62.39€ 59.42€ | |
| Levitra Soft Tabs | 20mg | 30 + 2 Pills | 99.17€ 94.45€ | |
| Levitra Generic | 40mg | 20 Pills | 67.56€ 64.34€ | |
| Levitra Generic | 10mg | 120 + 10 Pills | 178.59€ 170.09€ | |
| Levitra Soft Tabs | 20mg | 180 + 10 Pills | 398.14€ 379.18€ | |
| Levitra Generic | 60mg | 10 Pills | 47.42€ 45.16€ |
10mg, or 20mg (milligrams) oral tablets.
Determination That Levitra (Vardenafil Hydrochloride) Oral Tablets, 5 Milligrams, 10 Milligrams, and 20 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness This table of contents is a navigational tool, processed from the headings within the legal text of Federal Register documents. This repetition of headings to form internal navigation links has no substantive legal effect. FederalRegister.gov retrieves relevant information about this document from Regulations.gov generic levitra without rx to provide users with additional context. This information is not part of the official Federal Register document. Requests that the FDA determine whether LEVITRA® (vardenafil HCl) 20 mg tablets approved under New Drug Application (NDA) 021400 and held by Bayer Healthcare Pharmaceuticals Inc.
has been withdrawn for reasons of safety or effectiveness; CLOSED Document page views are updated periodically throughout the day and are cumulative counts for this document. Counts are subject to sampling, reprocessing and revision (up or down) throughout the day. 2,287 as of 05/28/2026 at 10:15 am EDT This document is also available in the following formats: 2023-09365 as it appeared on Public Inspection on 05/02/2023 at 8:45 am. It was viewed 13 times while on Public Inspection. If you are using public inspection listings for legal research, you should verify the contents of the documents against a final, official edition of the Federal Register.
Only official editions of the Federal Register provide legal notice of publication to the public and judicial notice to the courts under 44 U.S.C. Published Document: 2023-09365 (88 FR 27901) This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format. The Food and Drug Administration (FDA or Agency) has determined that Levitra (vardenafil hydrochloride) oral tablets, 5 milligrams (mg), 10 mg, and 20 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to these products as long as they meet relevant legal and regulatory requirements. It’s also sold as disintegrating
The “Discontinued Drug Product List” delineates, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness. FDA will not begin procedures to withdraw approval of approved ANDAs that refer to these drug products. Additional ANDAs for these drug products may also be approved by the Agency as long as they meet all other legal and regulatory requirements for the approval of ANDAs. If FDA determines that labeling for these drug products should be revised to meet current standards, the Agency will advise ANDA applicants to submit such labeling. Vardenafil (generic for Levitra®) improves erectile dysfunction (ED) by making it easier for blood to flow to the penis. tablets under the brand name Staxyn®.
It’s in the same class of drugs as Viagra®, Cialis®, and Stendra®, and like these other medications for ED, vardenafil is safe and effective when taken as prescribed. However, there are potential vardenafil side effects to consider, like headaches and nausea. While most adverse effects are mild, some may be more serious. We’ll list the common and uncommon side effects of vardenafil and what you can do to deal with them and improve your experience while using this medication for ED. These drugs increase blood flow to erectile tissues in the penis, making it easier to get and keep an erection with sexual stimulation. Vardenafil pills are designed to be
| Side Effect | Frequency | Severity | Notes |
|---|---|---|---|
| Headache | Common | Mild to Moderate | Usually subsides over time |
| Flushing | Common | Mild | Occasionally persistent |
| Nasal Congestion | Common | Mild | Temporary |
| Dizziness | Less Common | Mild | Especially when standing up |
| Dyspepsia | Less Common | Mild | Stomach upset |
taken about an hour before sexual activity.