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Search results for "PART 310 -- NEW DRUGS|Subpart E--Requirements for Specific New Drugs or Devices" in comments (approximate match)
Status:
Possibly Marketed Outside US
Class (Stereo):
CHEMICAL (ABSOLUTE)
Status:
Possibly Marketed Outside US
Class (Stereo):
CHEMICAL (ABSOLUTE)
Status:
US Approved Rx
(2012)
Source:
BLA022175
(2012)
Source URL:
First marketed in 1921
Class:
MIXTURE
Status:
US Approved Allergenic Extract
(1994)
Source:
BLA103738
(1994)
Source URL:
First marketed in 1921
Class:
MIXTURE
Targets:
Conditions:
Rosin is a natural product derived from pine trees and consists of a complex mixture of mutually soluble organic compounds. Rosin (colophony) is composed of approximately 70% resin acids. Rosins are produced commercially by one of the following three methods: (1) solvent extraction of aged and ground pine stumps (wood rosin), (2) extraction of crude tall oil as a byproduct of the Kraft pulping process for making paper followed by acidification and fractional distillation (tall oil rosin) and, (3) tapping the living tree to collect oleoresin followed by distillation to yield turpentine and a resinous substance (gum rosin). Because, gum, tall oil and wood rosins are obtained from pine trees, they are similar in composition. Rosin and its derivatives also exhibit wide ranging pharmaceutical applications. Rosin derivatives show excellent film forming and coating properties. They are also used for tablet film and enteric coating purpose. Rosins have also been used to formulate microcapsules and nanoparticles. Glycerol, sorbitol, and mannitol esters of rosin are used as chewing gum bases for medicinal applications. The degradation and biocompatibility of rosin and rosin-based biomaterials has been examined in vitro and in vivo. Rosin Gum is an important raw material for the manufacture of soap, paper, paint, and rubber; intermediate material for synthetic organic chemicals. Rosin in Rhodiola rosea L. preparations can effect the central nervous system by increasing the ability to concentrate, the mental and physical power; they are efficient in the asthenic states and improve general resistance of the cells and the organism against the harmful outer influence. They also prevent the heart system from stress and arrhythmias, and posses some antioxidant activity. Some data confirm that the Rhodiola rosea L. preparations stop the growth of the malignant tumors and metastases in the liver.
Status:
US Approved Allergenic Extract
(1972)
Source:
BLA102192
(1972)
Source URL:
First marketed in 1921
Class:
MIXTURE
Status:
US Previously Marketed
Source:
21 CFR 310.527(a) hair loss prevention polysorbate 60
Source URL:
First approved in 1938
Source:
Belladonna and Opium by Bryant Ranch Prepack
Source URL:
Class:
MIXTURE
Status:
US Previously Marketed
Source:
DEPINAR by ARMOUR PHARM
(1960)
Source URL:
First marketed in 1921
Class:
MIXTURE
Targets:
Tannic acid (TA) is a naturally occurring plant-derived polyphenol found in several herbaceous and woody plants, wines and a broad selection of teas. TA has strong antioxidant/free radical scavenging, anti-inflammatory, anti-viral/bacterial, and anti-carcinogenic properties. The neuroprotective effects of TA against Alzheimer’s disease (AD) have been shown in several in vitro and in vivo models of AD. Evidence suggests that TA is a natural inhibitor of β-secretase (BACE1) activity and protein expression. BACE1 is the primary enzyme responsible for the production and deposition of Aβ peptide. TA can also inhibit the in vitro aggregation of tau peptide, a core component of intracellular neurofibrillary tangles (NFTs). In addition, combination of tannic acid with eucalyptus Oil and Allantoin (from Comfrey) is known as homeopathic product which is used to temporarily relieve the aches and pains of muscles and joints associated with: arthritis, simple backache, strains, bruises, sprains.
Status:
US Previously Marketed
First marketed in 1921
Class:
PROTEIN
Status:
Possibly Marketed Outside US
First approved in 2019
Source:
Stozyme by Chunwoo Pharmaceutical Co., Ltd.
Source URL:
Class:
PROTEIN
Status:
US Previously Marketed
Source:
21 CFR 310.527(a) hair loss prevention polysorbate 20
Source URL:
First approved in 1978
Source:
60-Second Fluoride Pina Colada by Patterson Dental Supply Inc
Source URL:
Class:
POLYMER