Vardenafil Hydrochloride (Levitra®)
Section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C.
- Levitra is available in 10 mg and 20 mg tablets.
- The medication is not an aphrodisiac; it enhances ability when sexually stimulated.
- Vardenafil is a PDE5 inhibitor class drug.
- It can be used by men with diabetes-related erectile issues.
- Levitra may cause dizziness; avoid driving after taking.
- The medication is approved by the FDA for ED treatment.
- Do not use if you have severe liver or kidney problems.
- Vardenafil should be stored at room temperature, away from moisture.
- It is not suitable for women or children.
- Consult your doctor for potential drug interactions.
355(j)) allows the submission of an ANDA to market a generic version of a previously approved drug product.
| 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 |
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
Patient characteristics
Enter a search term or FR citation e.g. 88 FR 38230 FR 78782024-13208USDA09/05/24RULE0503-AA39SORN Choosing an item from full text search results will bring you to those results. Pressing levitra order uk enter in the search box will also bring you to search results. Choosing an item from suggestions will bring you directly to the content. 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That Levitra (Vardenafil Hydrochloride) Oral Tablets, 5 Milligrams, 10 Milligrams, and 20 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness This table of contents is a navigational tool, processed from the headings within the legal text of Federal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.
About Vardenafil Hydrochloride (Levitra®)
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. 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. of use, and (with certain exceptions) labeling as the listed drug, which is a version
| Product | Dosage | Quantity + Bonus | Price | |
|---|---|---|---|---|
| Levitra Generic | 20mg | 360 + 10 Pills | 458.44€ 436.61€ | |
| Levitra Generic | 60mg | 10 Pills | 47.42€ 45.16€ | |
| Levitra Generic | 20mg | 10 Pills | 31.49€ 29.99€ | |
| Levitra Generic | 20mg | 20 Pills | 52.63€ 50.12€ | |
| Levitra Generic | 60mg | 60 + 4 Pills | 198.85€ 189.38€ | |
| Levitra Generic | 60mg | 180 + 10 Pills | 501.43€ 477.55€ | |
| Levitra Original | 20mg | 48 + 4 Pills | 235.14€ 223.94€ | |
| Levitra Generic | 10mg | 120 + 10 Pills | 178.59€ 170.09€ | |
| Levitra Soft Tabs | 20mg | 180 + 10 Pills | 398.14€ 379.18€ | |
| Levitra Professional | 20mg | 60 + 2 Pills | 223.11€ 212.49€ | |
| Levitra Generic | 10mg | 180 + 10 Pills | 246.74€ 234.99€ |
of the drug that was previously approved, and (2) is bioequivalent to the listed drug.
Cited by (73)
If you feel chest pain, dizziness, or nausea during sex, stop and contact your healthcare provider right away. Vardenafil does not protect against sexually transmitted infections, including HIV. Vardenafil belongs to a group of medicines, known as phosphodiesterase-5 (PDE-5) inhibitors, which are used to treat erectile dysfunction or pulmonary arterial hypertension. You should not take more than one PDE-5 inhibitor medicine. Medicines in this group include avanafil (Stendra), sildenafil (Viagra, Revatio, and others), tadalafil (Cialis and others), and vardenafil (Levitra, Staxyn).
How to Take Vardenafil
Tell your healthcare provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if vardenafil is right for you. In particular, make sure that you discuss any of the following. Phenylalanine is found in vardenafil oral tablets and order levitra without prescription vardenafil orally disintegrating tablets. This substance can be harmful to people with PKU. ANDA applicants do not have to repeat the extensive clinical testing otherwise necessary to gain approval of a new drug application (NDA).
Key Takeaways
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Section snippets
Tell your healthcare provider if you have PKU. They can suggest a different treatment option for you. Tell your healthcare provider if you have any of the following. Heart problems, such as heart rhythm problems, chest pain, or heart failure Heart attack, stroke, or heart surgery within the past six months High blood pressure that is still too high despite taking medicines for it Peyronie's disease, or a penis with an abnormal curve or shape An erection lasting longer than four hours A blood disorder, such as sickle cell anemia An inherited eye disease called retinitis pigmentosa Vision loss, or a problem with the nerve between your eyes and brain (optic nerve) Health conditions or factors that raise the risk of optic nerve problems, such as diabetes, high cholesterol, smoking, being older than 50, or having a “crowded disc,” which is something an eye doctor may see during an eye exam Pulmonary veno-occlusive disease, a condition where blood vessels in the lungs are blocked People who can become pregnant are not usually prescribed vardenafil. It is not known if or how vardenafil could affect pregnancy or harm an unborn baby.
Are there any potential serious side effects for Stendra?
Tell your healthcare provider if you are or plan to become pregnant. People who can breastfeed are not usually prescribed vardenafil. It is not known if vardenafil passes into breast milk. Tell your healthcare provider if you are breastfeeding or plan to breastfeed. Grapefruit or grapefruit juice can raise vardenafil levels in your body, which can increase the risk of side effects. FDA publishes this list as part of the “Approved Drug Products With Therapeutic Equivalence Evaluations,” which is known
Data extraction
Any of the ingredients in the specific product dispensed Your pharmacist can tell you all of the ingredients in the specific vardenafil products they stock. Vardenafil should not be taken while you are using certain other medicines. Before taking vardenafil, tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details. Do not take vardenafil unless it has been prescribed to you by a healthcare provider.
Clin. Endocrinol. (Oxf)
Do not share vardenafil with other people, even if they have the same condition as you. Keep vardenafil out of the reach of children. Do not chew, cut, or crush vardenafil orally disintegrating tablets. Sexual activity can put extra strain on your heart, which may be unsafe for people with certain health problems, such as a recent heart attack. Talk to your healthcare provider to see if your heart is strong enough for sex. generally as the “Orange Book.” Under FDA regulations, drugs are removed from the list if the Agency withdraws
- Vardenafil requires a prescription; self-medicating is unsafe.
- Take Levitra approximately 60 minutes before intimacy.
- Do not take more than one dose per 24 hours.
- Symptoms like priapism need immediate medical attention.
- Levitra may cause nasal congestion or upset stomach.
- Combining vardenafil with other ED drugs increases risks.
- Alcohol can hinder the effectiveness of Levitra.
- Levitra is designed for occasional use, not daily.
- Precautions include monitoring for vision changes.
- Seek medical advice if you experience allergic reactions.
or suspends approval of the drug's NDA or ANDA for reasons of safety or effectiveness or if FDA
How do costs compare for vardenafil and tadalafil?
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.
Are you currently using Vardenafil (Levitra, Staxyn)?
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. Daniel Ritterbeck, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162).
Levitra (Generic Vardenafil) Overview
Vardenafil orally disintegrating tablets should not be taken with water or liquids. Let it dissolve on your tongue without crushing it. There are no known interactions between vardenafil and alcohol. Always tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. In particular, make sure that you discuss if you are using any of the following before taking vardenafil.
Where do I get this medication?
Tell your healthcare provider about all medicines that you take or have recently taken. This may not be a complete list of medicines that can interact with vardenafil. If you or someone else has taken too much vardenafil, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222. Take it as your healthcare provider recommends, which is usually about one hour before planned sexual activity. Do not take double or extra doses.
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