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Status:
US Approved Rx
(2014)
Source:
ANDA204605
(2014)
Source URL:
First approved in 1982
Source:
ZOVIRAX by GLAXOSMITHKLINE
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Acyclovir is a synthetic antiviral nucleoside analogue. A screening program for antiviral drugs begun at Burroughs Wellcome in the 1960s resulted in the discovery of acyclovir in 1974. Preclinical investigation brought the drug to clinical trials in 1977 and the first form of the drug (topical) was available to physicians in 1982. Activity of acyclovir is greatest against herpes 1 and herpes 2, less against varicella zoster, still less against Epstein-Barr, and very little against cytomegalovirus. Acyclovir is an antiviral agent only after it is phosphorylated in infected cells by a viral-induced thymidine kinase. Acyclovir monophosphate is phosphorylated to diphosphate and triphosphate forms by cellular enzymes in the infected host cell where the drug is concentrated. Acyclovir triphosphate inactivates viral deoxyribonucleic acid polymerase.
Status:
US Approved Rx
(2014)
Source:
ANDA204605
(2014)
Source URL:
First approved in 1982
Source:
ZOVIRAX by GLAXOSMITHKLINE
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Acyclovir is a synthetic antiviral nucleoside analogue. A screening program for antiviral drugs begun at Burroughs Wellcome in the 1960s resulted in the discovery of acyclovir in 1974. Preclinical investigation brought the drug to clinical trials in 1977 and the first form of the drug (topical) was available to physicians in 1982. Activity of acyclovir is greatest against herpes 1 and herpes 2, less against varicella zoster, still less against Epstein-Barr, and very little against cytomegalovirus. Acyclovir is an antiviral agent only after it is phosphorylated in infected cells by a viral-induced thymidine kinase. Acyclovir monophosphate is phosphorylated to diphosphate and triphosphate forms by cellular enzymes in the infected host cell where the drug is concentrated. Acyclovir triphosphate inactivates viral deoxyribonucleic acid polymerase.
Status:
US Approved Rx
(1982)
Source:
NDA017707
(1982)
Source URL:
First approved in 1982
Source:
NDA017707
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Indium In-111 pentetate disodium is a radioactive diagnostic indicated for use in radionuclide cisternography. Decay of In-111 by electron capture allows for detection with a gamma camera for visualization of the brain and spinal column. Indium In 111 pentetate ( 111In-DTPA) is indicated as an imaging agent in cisternography to study the flow of cerebrospinal fluid (CSF) in the brain, to diagnose abnormalities in CSF circulation, to assess and help localize the site of CSF leakage, and to test the patency of or localize blocks in CSF shunts.
Status:
US Approved Rx
(1982)
Source:
NDA017707
(1982)
Source URL:
First approved in 1982
Source:
NDA017707
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Indium In-111 pentetate disodium is a radioactive diagnostic indicated for use in radionuclide cisternography. Decay of In-111 by electron capture allows for detection with a gamma camera for visualization of the brain and spinal column. Indium In 111 pentetate ( 111In-DTPA) is indicated as an imaging agent in cisternography to study the flow of cerebrospinal fluid (CSF) in the brain, to diagnose abnormalities in CSF circulation, to assess and help localize the site of CSF leakage, and to test the patency of or localize blocks in CSF shunts.
Status:
US Approved Rx
(2014)
Source:
ANDA204605
(2014)
Source URL:
First approved in 1982
Source:
ZOVIRAX by GLAXOSMITHKLINE
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Acyclovir is a synthetic antiviral nucleoside analogue. A screening program for antiviral drugs begun at Burroughs Wellcome in the 1960s resulted in the discovery of acyclovir in 1974. Preclinical investigation brought the drug to clinical trials in 1977 and the first form of the drug (topical) was available to physicians in 1982. Activity of acyclovir is greatest against herpes 1 and herpes 2, less against varicella zoster, still less against Epstein-Barr, and very little against cytomegalovirus. Acyclovir is an antiviral agent only after it is phosphorylated in infected cells by a viral-induced thymidine kinase. Acyclovir monophosphate is phosphorylated to diphosphate and triphosphate forms by cellular enzymes in the infected host cell where the drug is concentrated. Acyclovir triphosphate inactivates viral deoxyribonucleic acid polymerase.
Status:
US Approved Rx
(2020)
Source:
ANDA206997
(2020)
Source URL:
First approved in 1982
Source:
NDA018602
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Diltiazem is a nondihydropyridines calcium channel blocker used in the treatment of hypertension, angina pectoris, and some types of arrhythmia. Diltiazem produces its antihypertensive effect primarily by relaxation of vascular smooth muscle and the resultant decrease in peripheral vascular resistance.
Status:
US Approved Rx
(2014)
Source:
ANDA204605
(2014)
Source URL:
First approved in 1982
Source:
ZOVIRAX by GLAXOSMITHKLINE
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Acyclovir is a synthetic antiviral nucleoside analogue. A screening program for antiviral drugs begun at Burroughs Wellcome in the 1960s resulted in the discovery of acyclovir in 1974. Preclinical investigation brought the drug to clinical trials in 1977 and the first form of the drug (topical) was available to physicians in 1982. Activity of acyclovir is greatest against herpes 1 and herpes 2, less against varicella zoster, still less against Epstein-Barr, and very little against cytomegalovirus. Acyclovir is an antiviral agent only after it is phosphorylated in infected cells by a viral-induced thymidine kinase. Acyclovir monophosphate is phosphorylated to diphosphate and triphosphate forms by cellular enzymes in the infected host cell where the drug is concentrated. Acyclovir triphosphate inactivates viral deoxyribonucleic acid polymerase.
Status:
US Approved Rx
(2002)
Source:
ANDA076005
(2002)
Source URL:
First approved in 1982
Source:
SPECTAZOLE by ALVOGEN
Source URL:
Class (Stereo):
CHEMICAL (RACEMIC)
Conditions:
Econazole (commonly used as the nitrate salt) is an antifungal medication of the imidazole class. It is a broad spectrum antimycotic with some action against Gram positive bacteria. It is used topically in dermatomycoses also orally and parenterally. Sold under the brand name Ecoza among others, it is indicated for the treatment of interdigital tinea
pedis caused by Trichophyton rubrum, Trichophyton mentagrophytes, and
Epidermophyton floccosum in patients 12 years of age and older. Econazole interacts with 14-α demethylase, a cytochrome P-450 enzyme necessary to convert lanosterol to ergosterol. As ergosterol is an essential component of the fungal cell membrane, inhibition of its synthesis results in increased cellular permeability causing leakage of cellular contents. Econazole may also inhibit endogenous respiration, interact with membrane phospholipids, inhibit the transformation of yeasts to mycelial forms, inhibit purine uptake, and impair triglyceride and/or phospholipid biosynthesis.
Status:
US Approved Rx
(2010)
Source:
ANDA090146
(2010)
Source URL:
First approved in 1982
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Conditions:
Ciclopirox is an antifungal medication indicated for the treatment of seborrheic dermatitis (Loprox trade name) and onychomycosis of fingernails and toenails due to Trichophyton rubrum (Penlac trade name). The drug exerts its action by chelating Fe3+ and Al3+, resulting in the inhibition of the metal-dependent enzymes that are responsible for the degradation of peroxides within the fungal cell.
Status:
US Approved Rx
(1991)
Source:
NDA019998
(1991)
Source URL:
First approved in 1982
Source:
NDA214993
Source URL:
Class (Stereo):
CHEMICAL (MIXED)
Targets:
Conditions:
Succimer is an analogue of dimercaprol, and has replaced dimercaprol as one of the main antidotes used in the management of poisoning by lead and other heavy metals. The advantages of succimer are that it is effective by oral administration because it is soluble in water, it is well-tolerated, has relatively low toxicity and can be given at the same time as iron supplements to treat iron deficiency anaemia. It does not cause significant increase in urinary excretion of essential minerals unlike the other widelyused lead chelating agent, sodium calcium EDTA.