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Search results for m root_codes_comments in Code Comments (approximate match)
Status:
US Approved Rx
(2015)
Source:
ANDA203002
(2015)
Source URL:
First marketed in 1921
Source:
Potassium Acetate U.S.P.
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Potassium is needed to maintain good health. When potassium level falls below 3.5 mmol/L, Hypokalemia is diagnosed. In case of extremely low level of potassium (lower than 2.5 mmol/L) the following symptoms are appeared: malaise and fatigue. This low level of potassium can lead to severe muscle weakness and paralysis; respiratory failure; intermittent muscle spasms. It is known, foods that are good sources of potassium and low in sodium may reduce the risk of high blood pressure and stroke. Potassium supplementation is also recommended as an adjuvant antihypertensive agent for patients with essential hypertension.
Status:
US Approved OTC
Source:
21 CFR 347.10(t) skin protectant zinc carbonate
Source URL:
First marketed in 1921
Source:
Precipitated Zinc Carbonate U.S.P.
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Conditions:
Zinc monocarbonate (Zinc Carbonate) is an inorganic salt. In the United States, Zinc Carbonate may be used as an active ingredient in OTC drug products. When used as an active drug ingredient, the established name is Zinc Carbonate. Zinc monocarbonate is generally recognized as safe by FDA. It is used as skin protectant active ingredient. Zinc carbonate was found to retard the degradation of some poly(lactide-co-glycolide) (PLG) microspheres in vivo and in vitro. Adding Zinc Carbonate is essential during the preparation of PLGA microspheres. It can remarkably improve the stability of drugs in the acid microenvironment inside PLGA microspheres.
Status:
US Approved OTC
Source:
21 CFR 347.10(t) skin protectant zinc carbonate
Source URL:
First marketed in 1921
Source:
Precipitated Zinc Carbonate U.S.P.
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Conditions:
Zinc monocarbonate (Zinc Carbonate) is an inorganic salt. In the United States, Zinc Carbonate may be used as an active ingredient in OTC drug products. When used as an active drug ingredient, the established name is Zinc Carbonate. Zinc monocarbonate is generally recognized as safe by FDA. It is used as skin protectant active ingredient. Zinc carbonate was found to retard the degradation of some poly(lactide-co-glycolide) (PLG) microspheres in vivo and in vitro. Adding Zinc Carbonate is essential during the preparation of PLGA microspheres. It can remarkably improve the stability of drugs in the acid microenvironment inside PLGA microspheres.
Status:
US Approved OTC
Source:
21 CFR 331.11(i)(2) antacid:calcium-containing calcium (mono or dibasic salt)
Source URL:
First marketed in 1921
Source:
Precipitated Calcium Phosphate N.F.
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Anhydrous dibasic calcium phosphate is a calcium salt of phosphoric acid. It is used as a diluent in pharmaceutical industry, in some toothpastes as a polishing agent. Calcium phosphate is generally recognized as safe by FDA. Dibasic calcium phosphate is ised as a supplement to treat conditions associated with calcium deficit, such as bone loss (osteoporosis), weak bones (osteomalacia/rickets), decreased activity of the parathyroid gland (hypoparathyroidism), and a certain muscle disease (latent tetany)
Status:
US Approved OTC
Source:
21 CFR 347.10(t) skin protectant zinc carbonate
Source URL:
First marketed in 1921
Source:
Precipitated Zinc Carbonate U.S.P.
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Conditions:
Zinc monocarbonate (Zinc Carbonate) is an inorganic salt. In the United States, Zinc Carbonate may be used as an active ingredient in OTC drug products. When used as an active drug ingredient, the established name is Zinc Carbonate. Zinc monocarbonate is generally recognized as safe by FDA. It is used as skin protectant active ingredient. Zinc carbonate was found to retard the degradation of some poly(lactide-co-glycolide) (PLG) microspheres in vivo and in vitro. Adding Zinc Carbonate is essential during the preparation of PLGA microspheres. It can remarkably improve the stability of drugs in the acid microenvironment inside PLGA microspheres.
Status:
US Approved OTC
Source:
21 CFR 350.10(e) antiperspirant aluminum dichlorohydrate
Source URL:
First marketed in 1903
Source:
EverDry by EverDry
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Burow invented an astringent antiseptic solution of aluminium acetate in water to relieve the itching and inflammation of minor skin irritations. At present the oflicial U. S. P. procedure to made Burow's solution involves the reaction of aluminum sulfate, calcium carbonate and acetic acid to form aluminum sub-acetate, also termed basic aluminum acetate.
The solution is available as an over-the-counter drug for topical administration, with brand names including Domeboro. Burow's solution has been shown to be effective against chronic suppurative otitis media and otitis externa. It is active against bacteria resulting in damage to the cell wall.
Status:
US Approved OTC
Source:
21 CFR 350.10(e) antiperspirant aluminum dichlorohydrate
Source URL:
First marketed in 1903
Source:
EverDry by EverDry
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Burow invented an astringent antiseptic solution of aluminium acetate in water to relieve the itching and inflammation of minor skin irritations. At present the oflicial U. S. P. procedure to made Burow's solution involves the reaction of aluminum sulfate, calcium carbonate and acetic acid to form aluminum sub-acetate, also termed basic aluminum acetate.
The solution is available as an over-the-counter drug for topical administration, with brand names including Domeboro. Burow's solution has been shown to be effective against chronic suppurative otitis media and otitis externa. It is active against bacteria resulting in damage to the cell wall.
Status:
Investigational
Source:
NCT01855230: Phase 2 Interventional Completed COPD
(2013)
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
1,1-DIETHYL-4-PHENYLHOMOPIPERAZINIUM (ASM-024), a small synthetic molecule in clinical stage development, has shown activity at the level of nicotinic receptors and possibly at the muscarinic level and presents anti-inflammatory and bronchodilator properties. Aerosolized ASM-024 reduces airway resistance in mice and promotes in-vitro relaxation of tracheal and bronchial preparations from animal and human tissues. ASM-024 increased in vitro relaxation response to maximally effective concentration of short-acting beta-2 agonists in dog and human bronchi. ASM-024 is able to activate the α7 nAChR channel opening in the presence of the positive allosteric modulator (PNU-120596), indicating that ASM-024 behaves as a ‘silent agonist’ that places the receptor in a desensitized state. Compounds with similar properties have been shown to induce signal transduction pathways independently of ion channel activation. ASM-024 has demonstrated an antagonist effect on ACH-evoked activation at the M1, M2 and M3 muscarinic receptors expressed in Xenopus oocytes. A comprehensive nonclinical safety program was conducted with ASM-024 including pharmacokinetic and metabolism studies, safety pharmacology studies, toxicology and genotoxicity studies. In all, seven clinical studies were completed to evaluate the safety, tolerability and clinical activity of ASM-024. Three Phase I and four Phase II clinical trials were conducted on healthy subjects and patients with mild allergic asthma, stable moderate asthma and subjects with COPD. Altogether, ASM-024 has been safely administered to more than 200 subjects via the oral and inhalation delivery, i.e. nebulized solution and dry powder inhalation. However, the outcome of two phase II pilot studies in patients failed to demonstrate sufficient efficacy of ASM-024 in asthma and COPD. Thus, further work on ASM-024 on pulmonary diseases was stopped. In light of the findings that ASM‐024 blocks both nicotinic and muscarinic receptor activation, it is believed that ASM-024 will be a potent inhibitor of cell growth. These properties may have the potential to reduce the development or progression of tumors expressing these receptors.
Based on a greater knowledge of the unique pharmacological mechanisms of action of ASM-024 developed at Asmacure, Odan is exploring the potential therapeutic role of ASM-024 in the treatment of selected oncology diseases. These studies include the in vitro anti-proliferative properties against a panel of various cancer cell lines and the in vivo anti-tumor activity in selected mouse models. Overall, the most significant inhibitory effect on in vitro cell proliferation was observed on the following cell lines: human lung adenocarcinoma, breast cancer, brain neuroblastoma, prostate adenocarcinoma and malignant melanoma. Preliminary data from a mouse model of lung carcinoma (Lewis Lung Cancer) using a slow infusion delivery method that ASM-024 treatment reduces the size and number of tumor nodules in the lung. In addition the potential therapeutic synergism between ASM-024 with commonly used chemotherapeutic agents will be investigated. Cisplatin and the taxanes (e.g. paclitaxel or Taxol) are commonly used chemotherapeutic agents, but their use is limited by their toxicity rates and innate or acquired resistance to these drugs. The concomitant effect of ASM-024 and cisplatin or Taxol on the proliferation of tumor cells will be assessed in vitro and potentially in in vivo mouse models. In the long term, Odan will consider to pursue the development of ASM-024 in a solution formulation administered intravenously (IV) in conjunction with the commonly-used cancer chemotherapeutic agents, for the growth inhibition and possibly regression of tumors in cancer patients.
Status:
US Previously Marketed
Source:
Hydrochloric Acid U.S.P.
(1921)
Source URL:
First marketed in 1921
Source:
Hydrochloric Acid U.S.P.
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
HYDROCHLORIC ACID is formed by dissolving hydrogen chloride gas in water. It is a strong corrosive acid that is commonly used as a laboratory reagent. Also, it constitutes the majority of gastric acid, the human digestive fluid. Skin contact with HYDROCHLORIC ACID can cause redness, pain, and severe skin burns. It may cause severe burns to the eye and permanent eye damage.