GS0051: Pharmaceutical preparations for the prevention and treatment of disorders and diseases in or affecting the central nervous system; Pharmaceutical preparations for the treatment of the brain, central nervous system, and psychiatric and neurological diseases and disorders; Pharmaceutical preparations and substances for the prevention and treatment of major depressive disorder, mood disorder, psychosis, anxiety, epilepsy, sclerosis, porphyries, stroke, Huntington's disease, insomnia, Parkinson's disease, cognitive impairment; Pharmaceutical preparations for the treatment of ectoparasites, such as head lice; Steroids; Pharmaceutical preparations containing prednisolone for the prevention and treatment of disorders of the nervous system, the immune system, the cardio-vascular system, the metabolic system, the respiratory system, the musculoskeletal system, the genitourinary system; Pharmaceutical preparations containing prednisolone for the treatment of inflammatory disorders; Pharmaceutical preparations containing prednisolone for use in dermatology, oncology, hematology and in tissue and organ transplantation, in ophthalmology and for gastroenterological disorders; Medical delivery apparatus, namely, a valved holding chamber sold empty for use with metered dose inhalers; Cephalosporins; Antibiotics; Pharmaceutical preparations for the treatment of reflux, esophagitis, GERD (Gastro-Esophageal Reflux Disease), dyspepsia, heartburn, acid regurgitation, pyrosis, epigastric pain, irritative cough and dysphonia; Oral modified release, extended release, and/or sustained release pharmaceutical preparations for the drug carbinoxamine, a pharmaceutically acceptable salt thereof and/or carbinoxamine polistirex, intended for the treatment of seasonal and perennial allergic rhinitis, and other approved uses; Vitamin, mineral and fluoride preparations for human medical or nutritional uses; Nutritional preparation in the nature of nutritional supplement containing vitamins and fluoride; Pharmaceutical products and treatments for pediatric onset and rare and orphan disorders, namely, oral formulation of D-galactose for the treatment of phosphoglucomutase 1 (PGM1) deficiency (PGM1-CDG), oral formulation of D-mannose for the treatment of Mannose Phosphate Isomerase (MPI) deficiency (MPI-CDG), oral formulation of L-fucose for the treatment of Leukocyte Adhesion Deficiency Type II (LADII) (SLC35C1-CDG), nucleotide prodrug for the treatment of Deoxyguanosine Kinase (DGUOK) deficiency; Pharmaceutical products and treatments for pediatric onset and rare and orphan disorders, namely, oral formulations for the treatment of congenital disorders of glycosylation; Pharmaceutical products and treatments for pediatric onset and rare and orphan disorders, namely, oral nucleotide replacements for the treatment of Myelodysplastic Syndromes; Pharmaceutical preparations and substances for the treatment of neurogenic orthostatic hypotension (nOH) associated with neurodegenerative diseases such as Parkinson's Disease, Multiple Systems Atrophy, and Pure Autonomic Failure; Transmembrane AMPA receptor regulatory proteins (TARPs) for use as anticonvulsant agents and to modulate neurotransmission in patients with epilepsy; Oral neuro-selective adjunctive medications; Selective kappa opioid receptor (KOR) antagonist for the treatment of major depressive disorder (MDD) and for substance use disorders
Case File Event Statements
12/2/2019 - 4 years ago
18 - ABANDONMENT NOTICE E-MAILED - AFTER PUBLICATIONType:MAB5
12/2/2019 - 4 years ago
17 - ABANDONMENT - AFTER PUBLICATIONType:ABN5
11/26/2019 - 4 years ago
16 - TEAS EXPRESS ABANDONMENT RECEIVEDType:EXAR
10/28/2019 - 4 years ago
15 - EXTENSION OF TIME TO OPPOSE RECEIVEDType:ETOF
10/8/2019 - 4 years ago
14 - OFFICIAL GAZETTE PUBLICATION CONFIRMATION E-MAILEDType:NPUB
10/8/2019 - 4 years ago
13 - PUBLISHED FOR OPPOSITIONType:PUBO
9/18/2019 - 4 years ago
12 - NOTIFICATION OF NOTICE OF PUBLICATION E-MAILEDType:NONP
9/5/2019 - 5 years ago
11 - ASSIGNED TO LIEType:ALIE
9/2/2019 - 5 years ago
10 - APPROVED FOR PUB - PRINCIPAL REGISTERType:CNSA
8/30/2019 - 5 years ago
9 - TEAS/EMAIL CORRESPONDENCE ENTEREDType:TEME
8/30/2019 - 5 years ago
8 - CORRESPONDENCE RECEIVED IN LAW OFFICEType:CRFA
8/30/2019 - 5 years ago
7 - TEAS RESPONSE TO OFFICE ACTION RECEIVEDType:TROA
8/1/2019 - 5 years ago
6 - NOTIFICATION OF PRIORITY ACTION E-MAILEDType:GPRN
8/1/2019 - 5 years ago
5 - PRIORITY ACTION E-MAILEDType:GPRA
8/1/2019 - 5 years ago
4 - PRIORITY ACTION WRITTENType:CPRA
7/25/2019 - 5 years ago
3 - ASSIGNED TO EXAMINERType:DOCK
5/25/2019 - 5 years ago
2 - NEW APPLICATION OFFICE SUPPLIED DATA ENTERED IN TRAMType:NWOS