ADCIRCA

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

FDA-2024-P-5963

Lachman Consultant Services, Inc. filed this suitability petition on behalf of a client requesting that the FDA declare Tadalafil Tablets, 40 mg suitable for submission as an ANDA under Section 505(j)(2)(C) of the FD&C Act, with ADCIRCA (tadalafil) Tablets, 20 mg by Eli Lilly as the reference listed

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

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