Cost and Availability of Generic Vardenafil 10mg
submitted a citizen petition dated August 29, 2022 (Docket No.
- Levitra 10mg is a popular choice due to fewer side effects.
- It should be used with caution in high blood pressure patients.
- The medication is available in blister packs for convenience.
- Do not use if allergic to vardenafil.
- Seek emergency care if adverse reactions occur.
- The tablet should be taken as needed, not daily.
- Avoid grapefruit or grapefruit juice while taking Levitra.
- Use caution if combining with recreational drugs.
- The medication may cause mild indigestion.
- Levitra 10mg has a fast acting formula.
- Always keep the medication out of children's reach.
FDA-2022-P-2060), under 21 CFR 10.30, requesting that the Agency determine whether Levitra (vardenafil hydrochloride)
Related/similar drugs
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Is Vardenafil affected by stress or Anxiety levels?
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That Levitra (Vardenafil Hydrochloride) Oral Tablets, 5 Milligrams, 10 Milligrams, and 20 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness This table of contents is a navigational tool, processed from the headings within the legal text of Federal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 levitra 5mg online 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under New Drug Application (NDA) 021400 and held by Bayer Healthcare Pharmaceuticals Inc. oral tablets, 20 mg, were withdrawn from sale for reasons of safety or effectiveness.
| Product | Dosage | Quantity + Bonus | Price | |
|---|---|---|---|---|
| Levitra Generic | 10mg | 10 Pills | 28.93€ 27.55€ | |
| Levitra Generic | 20mg | 20 Pills | 52.63€ 50.12€ | |
| Levitra Professional | 20mg | 120 + 4 Pills | 348.44€ 331.85€ | |
| Levitra Generic | 60mg | 30 + 2 Pills | 109.43€ 104.22€ | |
| Levitra Generic | 40mg | 20 Pills | 67.56€ 64.34€ | |
| Levitra Soft Tabs | 20mg | 10 Pills | 52.27€ 49.78€ | |
| Levitra Soft Tabs | 20mg | 60 + 4 Pills | 178.40€ 169.90€ | |
| Levitra Generic | 10mg | 180 + 10 Pills | 246.74€ 234.99€ | |
| Levitra Soft Tabs | 20mg | 120 + 8 Pills | 288.52€ 274.78€ | |
| Levitra Generic | 10mg | 30 + 4 Pills | 62.39€ 59.42€ | |
| Levitra Generic | 10mg | 90 + 8 Pills | 150.58€ 143.41€ | |
| Levitra Generic | 60mg | 90 + 6 Pills | 291.82€ 277.92€ | |
| Levitra Generic | 20mg | 270 + 10 Pills | 376.33€ 358.41€ |
Although the citizen petition did not address the 5 mg and 10 mg strengths, those strengths have also been discontinued.
Earn extra money
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. On our own initiative, we have also determined whether those strengths were withdrawn for safety or effectiveness reasons.
- Levitra 10mg tablets are designed for quick absorption.
- The medication helps achieve and maintain an erection.
- Alcohol consumption can diminish effectiveness.
- Use only as prescribed by a healthcare professional.
- It is not a cure, just a treatment for symptoms.
- The pill should be swallowed whole, not chewed.
- Some users may experience a headache after taking it.
- Do not take more than one tablet per day.
- Levitra 10mg is a safe option for most men when used properly.
- Always check ingredients if you have known allergies.
- Contact your doctor if side effects persist or worsen.
After considering the citizen petition and reviewing Agency records and based on the information we have at this time, FDA has determined under
| Condition | Precaution | Explanation |
|---|---|---|
| Nitrate medication use | Do not use with nitrates | Risk of severe hypotension |
| Heart problems | Consult cardiologist before use | May exacerbate underlying conditions |
| Liver impairment | Dose adjustment or avoid use | Reduced drug metabolism |
| Allergies to components | Check ingredients | Potential allergic reactions |
§ 314.161 that Levitra (vardenafil hydrochloride) oral tablets, 5 mg, 10 mg, and 20 mg, were not withdrawn for reasons of safety or effectiveness.
- Levitra 10mg is primarily used for male erectile dysfunction.
- The medication works by relaxing penile muscles.
- It helps increase blood flow during sexual arousal.
- Generic versions of Levitra may be available.
- Do not crush or break the tablet.
- Use caution if you have kidney or liver problems.
- Levitra 10mg does not protect against sexually transmitted infections.
- The medication is not intended for use in women.
- Side effects include dizziness and nasal congestion.
- Report any prolonged or painful erections to a doctor.
- Always follow your healthcare provider’s dosage instructions.
The petitioner has identified no data or other information suggesting that these drug products were withdrawn for reasons of safety or effectiveness.
What is Vardenafil?
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 8:15 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.
From Rybelsus to the Ozempic Pill: What Pharmacists Need to Know About the Next Generation of Oral Semaglutide
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.
What is Levitra?
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 mail order levitra online 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). We have carefully reviewed our files for records concerning the withdrawal of Levitra (vardenafil hydrochloride) oral tablets, 5 mg, 10 mg, and 20 mg, from sale.
What happens if I miss a dose?
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 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. We have also independently evaluated relevant literature and data for possible postmarketing adverse events.
| Side Effect | Frequency | Severity | Recommended Action |
|---|---|---|---|
| Headache | Common | Mild to moderate | Take pain relievers, stay hydrated |
| Flushing | Common | Mild | Cool environment, relax |
| Nasal Congestion | Common | Mild | Decongestants if needed |
| Dizziness | Occasionally | Moderate | Avoid driving, sit or lie down |
We have reviewed the available evidence and determined that these drug products were not withdrawn from sale for reasons of safety or effectiveness. Accordingly, the Agency will continue to list Levitra (vardenafil hydrochloride) oral tablets, 5 mg, 10
Pharmacist tips for Vardenafil
Stop using Levitra and get emergency medical help if you have: heart attack symptoms - chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating; heart attack symptoms - chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating; vision changes or sudden vision loss; or vision changes or sudden vision loss; or erection is painful or lasts longer than 4 hours (prolonged erection can damage the penis). erection is painful or lasts longer than 4 hours (prolonged erection can damage the penis). Stop using Levitra and call your doctor at once if you have: ringing in your ears, or sudden hearing loss; ringing in your ears, or sudden hearing loss; swelling in your hands, ankles, or feet; swelling in your hands, ankles, or feet; a light-headed feeling, like you might pass out; or a light-headed feeling, like you might pass out; or flushing (sudden warmth, redness, or tingly feeling); flushing (sudden warmth, redness, or tingly feeling); This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Pregnancy and breastfeeding
Do not use Levitra with similar medications such as avanafil (Stendra), sildenafil (Viagra), or tadalafil (Cialis). Tell your doctor about all other medications you use for erectile dysfunction. This list is not complete and many Other drugs may interact with vardenafil. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.
What else should I know about vardenafil?
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Levitra only for the for the indication prescribed. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. 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. mg, and 20 mg, in the “Discontinued Drug Product List” section of the Orange Book.
| Patient Age | Recommended Dose | Onset Time | Duration of Effect |
|---|---|---|---|
| 18-65 years | 10 mg, as needed | 30-60 mins | Up to 4-5 hours |
| Over 65 | Consult doctor | Varies | Varies |
| Special Cases | Follow medical advice | N/A | N/A |