TADALAFIL | N214522 | CMP DEVELOPMENT LLC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| D.N.J. | 2026-03-16 | Active | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition Withdrawal from Lachman Consultant Services, Inc. FDA-2012-P-0935 Lachman Consultant Services, Inc. requests withdrawal of its September 2012 Suitability Petition FDA-2012-P-0935 for Tadalafil Tablets, 40 mg, submitted under 21 CFR 10.25(a) and 10.30 to determine suitability for ANDA submission, because the FDA has since approved a substantially identical Suitabil | Suitability | 2025-06-17 | Withdrawn | — |
Lachman Consultant Services, Inc. - Citizen Petition FDA-2012-P-0935 Lachman Consultant Services, Inc. filed this petition on behalf of a client under Section 505(j)(2)(C) requesting that the FDA declare Tadalafil Tablets, 40 mg suitable for submission as an ANDA, with ADCIRCA (Tadalafil Tablets, 20 mg, NDA 22-332) as the reference-listed drug, seeking approval for a | Other | 2012-09-18 | Withdrawn | — |
Citizens Petition from Public Citizen's Health Research Group FDA-2005-P-0192 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.
Highest NADAC/Unit
$13.59
per ml
Lowest NADAC/Unit
$13.59
per ml
Brand NDCs
1
Generic NDCs
0
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 46287004515TADLIQ 20 MG/5 ML SUSPENSION | $13.59 | ML | Brand | — | 2026-10-01 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.