Section 505(j)(7) of the FD&C Act requires FDA to publish a list of all approved drugs.

Combining vardenafil with other ED medications is not recommended.
Side effects like vision changes are rare but should be reported.
It may take several attempts to find the correct dose for optimal effect.
Regular monitoring is advised if using vardenafil frequently.

FDA publishes this list as part of the “Approved Drug Products With Therapeutic Equivalence Evaluations,” which is known

What is vardenafil (Levitra®)?

Cialis can also be taken at a low dose once a day regularly, without regard to sexual activity. Then, sexual activity can occur at any time in combination with stimulation. This site displays a prototype of a “Web 2.0” version of the daily Federal Register. It is not an official legal edition of the Federal Register, and does not replace the official print version or the official electronic version on GPO’s govinfo.gov. The documents posted on this site are XML renditions of published Federal Register documents.

Are Levitra and Cialis the same?

Each document posted on the site includes a link to the corresponding official PDF file on govinfo.gov. This prototype edition of the daily Federal Register on FederalRegister.gov will remain an unofficial informational resource until the Administrative Committee of the Federal Register (ACFR) issues a regulation granting it official legal status. For complete information about, and access to, our official publications and services, go to About the Federal Register on NARA's archives.gov. The OFR/GPO partnership is committed to presenting accurate and reliable regulatory information on FederalRegister.gov with the objective of establishing the XML-based Federal Register as an ACFR-sanctioned publication in the future. While every effort has been made to ensure that the material on FederalRegister.gov is accurately displayed, consistent with the official SGML-based PDF version on govinfo.gov, those relying on it for legal research should verify their results against an official edition of the Federal Register. generally as the “Orange Book.” Under FDA regulations, drugs are removed from the list if the Agency withdraws

Product	Dosage	Quantity + Bonus	Price
Kamagra Polo	100mg	120 + 6 Pills	327.15€ 311.57€
Kamagra Soft Tabs	100mg	120 + 6 Pills	311.78€ 296.93€
Kamagra Oral Jelly	100 mg	110 + 9 Sachets	334.87€ 318.92€
Viagra Generic	150mg	60 + 4 Pills	111.25€ 105.95€
Kamagra Effervescent Tablets	100 mg	63 + 7 Pills	171.99€ 163.80€
Levitra Professional	20mg	270 + 6 Pills	738.98€ 703.79€
Cialis Super Active	20mg	20 + 4 Pills	92.35€ 87.95€
Levitra Generic	60mg	360 + 10 Pills	906.69€ 863.51€
Kamagra Polo	100 mg	12 Pills	60.21€ 57.34€
Viagra Generic	25mg	120 + 6 Pills	125.56€ 119.58€
Levitra Generic	40mg	10 Pills	41.37€ 39.40€

or suspends approval of the drug's NDA or ANDA for reasons of safety or effectiveness or if FDA

Dosing & Uses

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Approved as Treatment by the FDA

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 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. determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162).

Cited by (73)

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). 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.

20 mg vardenafil can be part of a treatment plan for erectile health.
Always inform your doctor of all medications and supplements you take.
Using vardenafil does not protect against sexually transmitted infections.
Remember to seek medical advice if erectile issues persist despite medication.

This determination may be made at any time after the drug has been withdrawn from sale, but must

Vardenafil may interact with medications for blood pressure or prostate issues.
Patients with heart problems should discuss risks with their doctor before use.
The medication is not intended for use by women.
Avoid taking vardenafil with fatty meals to improve absorption time.

be made prior to approving an ANDA that refers to the listed drug (§ 314.161 (21 CFR 314.161)).

Side Effect	Frequency	Severity
Headache	Common	Mild to Moderate
Flushing	Common	Mild
Nasal Congestion	Less Common	Mild
Dizziness	Less Common	Mild

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)

How To Get Vardenafil

For example, Revatio contains sildenafil, like Viagra, but is used for pulmonary arterial hypertension (high blood pressure in the lungs). Healthcare providers may also prescribe Cialis in lower doses for benign prostatic hyperplasia (BPH). Few studies directly compare vardenafil and sildenafil. An older study of these drugs, plus tadalafil, found vardenafil to be more potent than sildenafil, though both effectively treated ED. Tadalafil (Cialis) was preferred for its longer-lasting effects but was similarly effective.

Vardenafil may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

Another study found vardenafil to be better tolerated than sildenafil. The American Urological Association does not favor one over the other, focusing on individual suitability. Experts also recommend lifestyle changes and mental health referrals in ED treatment. Adjusting diet and increasing exercise may help. Numbness, burning, or tingling in the hands, arms, feet, or legs Pain in the muscles, back, arms, or legs A serious eye condition known as nonarteritic anterior ischemic optic neuropathy (NAION) can occur with vardenafil or Viagra. the subject of NDA 021400, held by Bayer HealthCare Pharmaceuticals, Inc., and initially approved on August 19, 2003.

Vardenafil Generic Name & Formulations

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 6:15 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.

Patient Q&A Section about levitra

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: cenforce 150mg tablets 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. Levitra is a phosphodiesterase 5 inhibitor indicated for the treatment of erectile dysfunction.

Drug	Onset of Action	Duration	Efficacy Rating	Comments
Vardenafil	30-60 min	Up to 5 hrs	High	Less affected by food intake
Sildenafil	30-60 min	Up to 4 hrs	Moderate to High	Commonly used, less selective
Tadalafil	30 min - 2 hrs	Up to 36 hrs	Very High	Longer duration of effect
Avanafil	15-30 min	Up to 6 hrs	High	Fastest onset

In letters dated September 26, 2019, September 24, 2020, and September 20, 2021, Bayer HealthCare Pharmaceuticals, Inc.

Is Vardenafil or Viagra More Effective for You?

If you notice vision changes or loss, stop taking these medications and seek medical help immediately. Individuals with a history of NAION or a "crowded" optic disc are at greater risk. Some may also experience color vision changes, such as seeing blue tinges or difficulty telling blue and green apart. Inform your healthcare provider about any heart problems, as there are heart-related risks with sexual activity. You have an erection lasting more than four hours.

What should I do if I miss a dose of vardenafil?

You have symptoms of an allergic reaction, such as hives, difficulty breathing, or swelling of the face, lips, tongue, or throat. You have vision changes or vision loss in one or both eyes. Vardenafil or Viagra interact with various drugs, so be sure to tell your healthcare provider about all of the medications you take, including prescription and over-the-counter (OTC) drugs, vitamins, and supplements. Vardenafil or Viagra should never be taken with nitrate drugs such as isosorbide mononitrate or nitroglycerin. Vardenafil or Viagra can also interact with other medications, such as: Alpha blockers, which are used to treat BPH and high blood pressure: Examples include Flomax (tamsulosin) and Uroxatral (alfuzosin) Other blood pressure medications, such as Norvasc (amlodipine) Certain antifungals, such as ketoconazole and itraconazole To get the best results, follow the instructions on your medication's label for taking it. notified FDA that Levitra (vardenafil hydrochloride) oral tablets, 5 mg, 10 mg and 20 mg, respectively, were being

What is vardenafil?

Generally, Viagra and vardenafil have similar recommendations for how to take them, which are: Both should be taken about 60 minutes before sex for optimal response. However, Viagra can be taken anywhere between 30 minutes and up to four hours before sexual activity. Sexual stimulation is required for the medication to take effect. Do not take more than one tablet (regardless of dosage) in a 24-hour period. If your results with either medication are not as expected, consult your healthcare provider for professional medical advice.

What are common drug interactions for vardenafil and sildenafil?

You may need fildena 120 a higher or lower dose or a different medication. Cialis is a commonly prescribed medication for ED. Like vardenafil and Viagra, Cialis takes about 60 minutes to work and must be used in combination with sexual stimulation. There are two ways to take Cialis. The first way is similar to vardenafil or Viagra, which is to take it about an hour before sexual activity. discontinued, and FDA moved the drug products to the “Discontinued Drug Product List” section of the Orange Book.

Region	Approximate Cost	Notes
North America	$10 - $15	Generic versions available
Europe	€8 - €12	Brand and pharmacy differences
Asia	$2 - $8	Widely available, varies by country
Online Pharmacies	$3 - $10	Verify authenticity