DOCETAXEL | N020449 | SANOFI AVENTIS US LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from HYMAN, PHELPS & MCNAMARA, P.C. FDA-2020-P-1844 · 2 docket documents The law firm Hyman, Phelps & McNamara filed this citizen petition on behalf of an unnamed party requesting that FDA amend the Orange Book to designate Docetaxel Injection (20mg/ml, 80mg/4ml, and 160mg/8ml) approved under NDA 205934 as an additional Reference Listed Drug and Reference Standard. The p | 505(q) | 2020-09-03 | Open | HYMAN, PHELPS & MCNAMARA, P.C. |
Onco Therapies Limited (Strides Inc.) - Citizen Petition FDA-2012-P-1127 · 4 docket documents Onco Therapies Limited, represented by Strides Inc., filed this petition on November 7, 2012, requesting that the FDA declare Docetaxel Injection, 20 mg/mL in 8 mL fill suitable for submission as an abbreviated new drug application under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic A | Other | 2012-11-21 | Granted | — |
Onco Therapies Limited (Strides, Inc.) - Citizen Petition FDA-2012-P-0589 · 3 docket documents Onco Therapies Limited (Strides, Inc.) filed this citizen petition on June 4, 2012, requesting that the FDA declare Docetaxel Injection 20 mg/mL in 8 mL fill (160 mg total drug content) suitable for submission as an abbreviated new drug application under Section 505(j)(2)(C) of the Federal Food, Dru | Other | 2012-06-08 | Withdrawn | — |
Sandoz, Inc. - Citizen Petition FDA-2011-P-0488 · 4 docket documents Sandoz Inc. submitted this citizen petition under 21 C.F.R. § 10.30 and 314.161(b) requesting that the FDA determine Taxotere (docetaxel) injection 40 mg/mL, approved under NDA 020449 and currently sponsored by Sanofi Aventis US, was not voluntarily withdrawn or withheld from sale for safety or effe | 505(q) | 2011-07-18 | Granted | — |
Mike Bernstein, MPH - Citizen Petition FDA-2010-P-0639 · 6 docket documents Mike Bernstein, MPH filed this suitability petition under Section 505(j)(2)(c) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare an additional strength of docetaxel injection concentrate, intravenous infusion suitable for submission via an Abbreviated New Drug Application ( | Other | 2011-01-14 | Granted | — |
OncoTherapies Limited - Citizen Petition FDA-2010-P-0130 · 6 docket documents OncoTherapies Limited filed this citizen petition on March 3, 2010, pursuant to Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act, requesting that the FDA declare Docetaxel Injection 20 mg/mL suitable for consideration as an abbreviated new drug application based on the reference list | Other | 2010-03-16 | Withdrawn | — |
Hyman, Phelps & McNamara, P.C. - Citizen Petition FDA-2010-P-0086 · 10 docket documents Hyman, Phelps & McNamara, P.C. filed this petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare a different initial dosage form (lyophilized powder for solution) and an additional strength (200 mg) of docetaxel injection concentrate, intraven | Other | 2010-02-22 | Denied | — |
Sanofi-Aventis U.S. LLC - Citizen Petition FDA-2009-P-0272 · 3 docket documents Sanofi-Aventis U.S. LLC submitted this petition under sections 505(b) and 505(j) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA require applicants submitting ANDAs or 505(b)(2) applications for docetaxel products to provide clinical pharmacokinetic data demonstrating that differ | 505(q) | 2009-06-29 | Partially Denied | — |
State of Connecticut FDA-2005-P-0004 · 50 docket documents Researchers from the National Cancer Institute conducted a randomized phase II trial of docetaxel (Taxotere) combined with thalidomide in patients with androgen-independent prostate cancer, based on their individual single-agent activity and evidence of complementary mechanisms of action. The study | Other | 2005-05-04 | Granted | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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