If FDA determines that labeling for
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mg tablets approved under New Drug Application (NDA) 021400 and held by Bayer Healthcare Pharmaceuticals Inc. has been withdrawn for reasons of safety or effectiveness; CLOSED Document page views are updated periodically throughout the day and are cumulative counts for this document.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. these drug products should be revised to
| Product | Dosage | Quantity + Bonus | Price | |
|---|---|---|---|---|
| Kamagra Gold | 100 mg | 60 + 4 Pills | 201.34€ 191.75€ | |
| Viagra Generic | 100mg | 120 + 6 Pills | 149.50€ 142.38€ | |
| Cialis Black | 80mg | 270 + 10 Pills | 502.88€ 478.93€ | |
| Levitra Generic | 60mg | 90 + 6 Pills | 291.82€ 277.92€ | |
| Viagra Generic | 150mg | 60 + 4 Pills | 111.25€ 105.95€ | |
| Kamagra Polo | 100mg | 180 + 8 Pills | 446.52€ 425.26€ | |
| Kamagra | 100mg | 12 Pills | 55.64€ 52.99€ | |
| Levitra Generic | 60mg | 360 + 10 Pills | 906.69€ 863.51€ | |
| Cialis Black | 80mg | 20 Pills | 71.83€ 68.41€ | |
| Kamagra Soft Tabs | 100 mg | 60 + 4 Pills | 180.59€ 171.99€ | |
| Cialis Generic | 5mg | 60 + 4 Pills | 86.02€ 81.92€ | |
| Kamagra Gold | 100 mg | 84 + 6 Pills | 264.44€ 251.85€ |
meet current standards, the Agency will
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has determined that Levitra (vardenafil hydrochloride) oral tablets, 5 milligrams (mg), 10 mg, and 20 mg, were not withdrawn from sale for reasons of safety or effectiveness.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. 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, sex tablet women whether a listed drug was withdrawn from sale for reasons of safety or effectiveness. advise ANDA applicants to submit such labeling.
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. Until the ACFR grants it official status, the XML rendition of the daily Federal Register on FederalRegister.gov does not provide legal notice to the public or judicial notice to the courts. Enter a search term or FR ed gel 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 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. 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.