MALATHION | N018613 | TARO PHARMACEUTICAL INDUSTRIES LTD
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
TARO PHARMACEUTICAL INDUSTRIES LTD. et al v. NOVITIUM PHARMA, LLC 2 patentsANDA 212255malathion | D.N.J. | 2019-01-24 | Terminated 2020-06-29 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Amendment to Suitability Petition from Felix Pharmaceuticals Pvt. Ltd. FDA-2026-P-5875 Felix Pharmaceuticals Pvt. Ltd. filed an amendment to a suitability petition regarding Galliprant (grapiprant tablets) 20 mg, 60 mg, and 100 mg, a prostaglandin E2 EP4 receptor antagonist non-steroidal anti-inflammatory drug for oral use in dogs with osteoarthritis, marketed by Elanco US Inc. The pe | Suitability | 2026-06-16 | Open | Felix Pharmaceuticals Pvt. Ltd. |
Citizen Petition from HQ Pharma (Shanghai) Co., Ltd. FDA-2026-P-2443 HQ Pharma (Shanghai) Co., Ltd. filed this citizen petition under Section 505(j)(2)(C) of the FD&C Act requesting that the FDA revise the Draft Guidance on Cariprazine Hydrochloride (RLD number 204370) to include product-specific guidance for cariprazine hydrochloride capsules at 0.5 mg and 0.75 mg s | Other | 2026-03-10 | Open | HQ Pharma (Shanghai) Co. |
Citizen Petition from Contraceptive Study Group FDA-2026-P-2301 The Contraceptive Study Group filed this citizen petition requesting that the FDA remove Depot Medroxyprogesterone Acetate (DMPA/Depo Provera) from the market based on its pronounced effects on bone mineral density, or alternatively modify its black box warning to include specific language about bon | Other | 2026-03-06 | Open | Contraceptive Study Group |
Citizen Petition from Providence St. Peter Hospital / Centralia Hospital FDA-2022-P-2238 Providence St. Peter Hospital, represented by pharmacists including Julie McCoy, filed this citizen petition under 21 C.F.R. § 10.25(a) requesting that the FDA amend the boxed warning for droperidol by removing five sentences that address prescribing restrictions, QT prolongation risk statements, an | Other | 2022-09-14 | Withdrawn | Providence St. Peter Hospital / Centralia Hospital |
Attachment 4 - Postmarket-drug-safety-informationpatients-and-providers RE Su... FDA-2021-P-0344 Zydus Pharmaceuticals USA Inc filed a citizen petition regarding postmarket drug safety information for patients and providers related to a suitability petition. The document appears to be an attachment addressing postmarket safety communication requirements, though the specific drug product name an | Suitability | 2022-08-12 | Open | Zydus Pharmaceuticals USA Inc |
Citizen Petition from Providence St. Peter Hospital/Centralia Hospital FDA-2022-P-1409 Providence St. Peter Hospital and Centralia Hospital, represented by Julie McCoy and other pharmacists, filed this citizen petition under 21 C.F.R. § 10.25(a) requesting that the FDA amend the boxed warning for droperidol by removing five sentences that the petitioners argue are redundant, overly pr | Other | 2022-07-01 | Denied | Providence St. Peter Hospital/Centralia Hospital |
Citizen Petition from Contraceptive Study Group FDA-2019-P-2289 The Contraceptive Study Group, comprised of William V. Williams, Joel Brind, Michael Manhart, Hanna Klaus, Angela Lanfranchi, Gerard Migeon, Michael Gaskins, Elvis Seman, Lester Ruppersberger, and Kathleen Raviele, filed this petition requesting that the FDA remove certain hormonal contraceptives fr | Other | 2019-05-10 | Partially Denied | Contraceptive Study Group |
Source: Regulations.gov. FDA citizen petitions matched by application number.