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Search results for "PART 522 IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS" in comments (approximate match)
Status:
Possibly Marketed Outside US
Source:
Equestrolin
Source URL:
First approved in 1987
Source:
ANDA211721
Source URL:
Class (Stereo):
CHEMICAL (RACEMIC)
Targets:
Conditions:
Luprostiol is a synthetic prostaglandin F2α and is a luteolytic agent. It is used for estrus control and termination of pregnancy in mares. In cattle Luprostiol is indicated for:
- Oestrus regulation / oestrus synchronization;
- Treatment of suboestrus;
- Induction of abortion;
- Induction of parturition;
- Treatment of pyometra, chronic endometritis and fetal mummification.
Status:
Possibly Marketed Outside US
First approved in 1966
Source:
NADA141033
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Atipamezole is a synthetic α2-adrenergic antagonist. It competitively inhibits α2-adrenergic receptors. Atipamezole is indicated for the reversal of the sedative and analgesic effects of Dexdomitor and Domitor in dogs. Adverse reactions: occasional vomiting may occur. At times, a period of excitement or apprehensiveness may be seen in dogs treated with atipamezole. Other effects of atipamezole include hypersalivation, diarrhea, and tremors.
Status:
Possibly Marketed Outside US
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Conditions:
Norgestomet is a synthetic derivative of progesterone with improved oral activity due to its 17α-acetate side chain. In veterinary medicine norgestomet is used for the synchronisation of oestrus in cattle. It is administered as a subcutaneous ear implant (containing 3 mg norgestomet;
to be removed after 9 to 10 days), in combination with a single intramuscular injection containing 3 mg norgestomet and 5 mg oestradiol valerate. The injection is to be given immediately after application of the implant. Norgestomet is not used in human medicine. It is a steroidal progestin of the 19-norprogesterone group.
Status:
Possibly Marketed Outside US
Source:
Nuital by Vaillant-Defresne
Source URL:
Class (Stereo):
CHEMICAL (RACEMIC)
Etymemazine (RP-6484), a phenothiazine derivative, is a sedative and neuroleptic agent. It is a histamine H₁-receptor antagonist. It was used to treat dementia. It was also used in veterinary.
Status:
Possibly Marketed Outside US
Class (Stereo):
CHEMICAL (RACEMIC)
Conditions:
Fenprostalene is a long-acting PGF2 alpha analog. Fenprostalene is indicated for use in feedlot heifers to induce abortion when pregnant 150 days or less, for the induction of parturition in sows and gilts pregnant at least 112 days.
Status:
Possibly Marketed Outside US
Class (Stereo):
CHEMICAL (RACEMIC)
Targets:
Conditions:
Prostalene is an analogue of prostaglandin PGF-2 alpha. It is used for the control of estrus in mares.
Status:
Possibly Marketed Outside US
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Sulfaethoxypyridazine an antibacterial sulfonamide compound. It is veterinary use only against bacterial infections, such as fowl cholera and salmonella infection.
Status:
Possibly Marketed Outside US
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Conditions:
Boldenone (INN, BAN), also known as Δ1-testosterone, 1-dihydrotestosterone, or androsta-1,4-dien-3-one-17β-ol (train name Equipoise) is a long-acting injectable anabolic agent for horses, supplied in a vial providing 50 mg boldenone undecylenate per mL in sesame oil with 3% (w/v) benzyl alcohol as a preservative. The activity of boldenone is mainly anabolic, with a low androgenic potency. Boldenone will increase nitrogen retention, protein synthesis increases appetite and stimulates the release of erythropoietin in the kidneys. Boldenone was synthesized in an attempt to create a long-acting injectable methandrostenolone (Dianabol), for androgen deficiency disorders. Boldenone acts similar to methandrostenolone with fewer adverse androgenic effects. Although commonly compared to nandrolone, boldenone lacks progesterone receptor interaction and all the associated progestogenic side effects. Equipoise (Boldenone Undecylenate Injection) is recommended as an aid for treating debilitated horses when an improvement in weight, haircoat or general physical condition is desired. Debilitation often follows disease or may occur following overwork and overexertion. Boldenone improves the general state of debilitated horses, thus aiding in correcting weight losses and improving appetite. It is not a substitute for a well-balanced diet. Optimal results can be expected only when good management and feeding practices are utilized. Boldenone should be considered only as adjunctive therapy to other specific and supportive therapy for diseases, surgical cases, and traumatic injuries.
Status:
US Approved Rx
(2025)
Source:
ANDA215922
(2025)
Source URL:
First approved in 1984
Source:
NADA128409
Source URL:
Class:
MIXTURE
Targets:
Ivermectin is a broad-spectrum anti-parasite medication. It was first marketed under the name Stromectol® and used against worms (except tapeworms), but, in 2012, it was approved for the topical treatment of head lice infestations in patients 6 months of age and older, and marketed under the name Sklice™ as well. Ivermectin is mainly used in humans in the treatment of onchocerciasis but is also effective against other worm infestations (such as strongyloidiasis, ascariasis, trichuriasis, and enterobiasis). Ivermectin binds selectively and with high affinity to glutamate-gated chloride ion channels in invertebrate muscle and nerve cells of the microfilaria. This binding causes an increase in the permeability of the cell membrane to chloride ions and results in hyperpolarization of the cell, leading to paralysis and death of the parasite. Ivermectin also is believed to act as an agonist of the neurotransmitter gamma-aminobutyric acid (GABA), thereby disrupting GABA-mediated central nervous system (CNS) neurosynaptic transmission. Ivermectin may also impair the normal intrauterine development of O. volvulus microfilariae and may inhibit their release from the uteri of gravid female worms. It is sold under brand names Heartgard, Sklice and Stromectol in the United States, Ivomec worldwide by Merial Animal Health, Mectizan in Canada by Merck, Iver-DT in Nepal by Alive Pharmaceutical and Ivexterm in Mexico by Valeant Pharmaceuticals International. In Southeast Asian countries, it is marketed by Delta Pharma Ltd. under the trade name Scabo 6.
Status:
US Approved OTC
Source:
21 CFR 349.12(c) ophthalmic:demulcents gelatin
Source URL:
First marketed in 1921
Class:
MIXTURE