VARDENAFIL HYDROCHLORIDE | N021400 | BAYER HEALTHCARE PHARMACEUTICALS INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Respira Therapeutics Inc. FDA-2022-P-2060 · 5 docket documents Respira Therapeutics Inc. filed this petition under 21 CFR §10.25(a) and §10.30 and pursuant to Sections 505(j) and 505(w) of the Federal Food, Drug and Cosmetic Act requesting that the FDA determine whether LEVITRA (vardenafil HCl) 20 mg tablets approved under NDA 021400 was withdrawn for reasons o | 505(q) | 2022-08-30 | Granted | Respira Therapeutics Inc. |
Citizen Petition from Alembic Pharmaceuticals Limited FDA-2019-P-2290 · 5 docket documents Alembic Pharmaceuticals Limited filed this citizen petition on May 10, 2019, requesting that the FDA determine the discontinuation of LEVITRA (Vardenafil Hydrochloride) Tablets, 2.5 mg, NDA #021400, was not for safety or effectiveness reasons, thereby permitting Alembic to submit an ANDA for its Var | 505(q) | 2019-05-14 | Granted | Alembic Pharmaceuticals Limited |
Citizens Petition from Public Citizen's Health Research Group FDA-2005-P-0192 · 5 docket documents Public Citizen filed this citizen petition pursuant to 21 U.S.C. Section 355(e)(3) and 21 C.F.R. 10.30 requesting that the FDA immediately add black box warnings to the three phosphodiesterase-5 inhibitors Viagra (sildenafil), Cialis (tadalafil), and Levitra (vardenafil), as well as to Revatio (sild | Other | 2005-10-20 | Denied | Public Citizen's Health Research Group |
Source: Regulations.gov. FDA citizen petitions matched by application number.
| Patent # | Expiration | PED | Drug Substance | Drug Product | Use Code | Delist |
|---|---|---|---|---|---|---|
| 8273876 | Jul 23, 2027 | — | — | — | — |