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Australia
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1. 17 Beta Estradiol
2. 17 Beta Oestradiol
3. 17 Beta-estradiol
4. 17 Beta-oestradiol
5. Aerodiol
6. Delestrogen
7. Estrace
8. Estraderm Tts
9. Estradiol
10. Estradiol 17 Alpha
11. Estradiol 17 Beta
12. Estradiol 17beta
13. Estradiol Anhydrous
14. Estradiol Hemihydrate
15. Estradiol Hemihydrate, (17 Alpha)-isomer
16. Estradiol Monohydrate
17. Estradiol Valeriante
18. Estradiol, (+-)-isomer
19. Estradiol, (-)-isomer
20. Estradiol, (16 Alpha,17 Alpha)-isomer
21. Estradiol, (16 Alpha,17 Beta)-isomer
22. Estradiol, (17-alpha)-isomer
23. Estradiol, (8 Alpha,17 Beta)-(+-)-isomer
24. Estradiol, (8 Alpha,17 Beta)-isomer
25. Estradiol, (9 Beta,17 Alpha)-isomer
26. Estradiol, (9 Beta,17 Beta)-isomer
27. Estradiol, Monosodium Salt
28. Estradiol, Sodium Salt
29. Estradiol-17 Alpha
30. Estradiol-17 Beta
31. Estradiol-17beta
32. Oestradiol
33. Ovocyclin
34. Progynon Depot
35. Progynon-depot
36. Progynova
37. Vivelle
1. 979-32-8
2. Estradiol 17-valerate
3. Delestrogen
4. Estradiol Valerianate
5. Oestradiol Valerate
6. Estraval
7. Neofollin
8. Progynova
9. Femogex
10. Progynon-depot
11. Atladiol
12. Climaval
13. Deladiol
14. Duratrad
15. Estate
16. Dura-estradiol
17. Exten Strone
18. Depo Estro Med
19. Repo-estra
20. Delestrogen 4x
21. Estraval Pa
22. Estraval 2x
23. Estroval-10
24. Delahormone Unimatic
25. Pelanin
26. Depo-estro-med
27. Femogen-l.a.
28. Gynogen L.a. 20
29. Gynogen L.a. 40
30. Deladumone
31. Estradiol, 17-valerate
32. Nsc-17590
33. Component Of Ditate
34. 17-beta-estradiol 17-valerate
35. B-estradiol 17-valerate
36. Component Of Deluteval 2x
37. Estradiol 17.beta.-valerate
38. Component Of Mal-o-fem L.a
39. .beta.-estradiol 17-valerate
40. Mls000028449
41. Chebi:31561
42. Okg364o896
43. 3-hydroxy-17beta-valeroyloxyestra-1,3,5(10)-trien
44. [(8r,9s,13s,14s,17s)-3-hydroxy-13-methyl-6,7,8,9,11,12,14,15,16,17-decahydrocyclopenta[a]phenanthren-17-yl] Pentanoate
45. Cyclocur
46. Gynokadin
47. Merimono
48. Nuvelle
49. Postoval
50. Primogyna
51. Ronfase
52. Smr000058346
53. Estradiol Depot
54. Primogyn-depot
55. Beta-estradiol 17-valerate
56. 17-pentanoyl-estra-1,3,5(10)-triene-3,17beta-diol
57. Gynogen L.a. 10
58. (17beta)-3-hydroxyestra-1,3,5(10)-trien-17-yl Valerate
59. Valergen
60. Estradiol 17beta-valerate
61. Estradiol Valerate (van)
62. Mfcd00056541
63. Estradioli Valeras
64. Valerate D'estradiol
65. Ccris 5571
66. Valerato De Estradiol
67. Estradioli Valeras [inn-latin]
68. Oestradiol-17b-valerate
69. Valerate D'estradiol [inn-french]
70. Einecs 213-559-2
71. Nsc 17590
72. Valerato De Estradiol [inn-spanish]
73. Altadiol
74. Pelanin Depot
75. Unii-okg364o896
76. Estradiol-valerate
77. Gynogen La
78. Deladumone (tn)
79. Ncgc00094673-01
80. (8r,9s,13s,14s,17s)-3-hydroxy-13-methyl-7,8,9,11,12,13,14,15,16,17-decahydro-6h-cyclopenta[a]phenanthren-17-yl Pentanoate
81. 3-hydroxy-17beta-valeroyloxyestra-1,3,5(10)-triene
82. Gynogen L.a.10
83. Estradiol Valerate [usp:inn:ban:jan]
84. St075188
85. Estradiol Valerate Icrs
86. Opera_id_444
87. Estradiol 17?-valerate
88. Dsstox_cid_3004
89. Chembl1511
90. Dsstox_rid_76827
91. Dsstox_gsid_23004
92. Schembl40563
93. Mls001146931
94. Gtpl7655
95. Dtxsid8023004
96. Estradiol Valerate [inn]
97. Estradiol Valerate [jan]
98. Estradiol Valerate [vandf]
99. Hms2232l17
100. Hms3259c12
101. Hms3715b21
102. Estradiol Valerate [mart.]
103. Bcp11918
104. Estra-1,3,5(10)-triene-3,17-diol (17-beta)-, 17-pentanoate
105. Estra-1,3,5(10)-triene-3,17-diol(17beta)-, 17-pentanoate
106. Estradiol Valerate (jan/usp/inn)
107. Estradiol Valerate [usp-rs]
108. Estradiol Valerate [who-dd]
109. Hy-b0672
110. Nsc17590
111. Zinc3881556
112. Estradiol 17-valerate [mi]
113. Tox21_111312
114. Estra-1,3,5(10)-triene-3,17-diol (17.beta.)-, 17-pentanoate
115. Lmst02010039
116. S3149
117. Akos005267158
118. Estradiol-17-valerate; 1,3,5(10)-estratriene-3,17b-diol 17-pentanote
119. Ccg-221130
120. Db13956
121. Estradiol Valerate [green Book]
122. Fd12049
123. Ks-5213
124. Nc00560
125. Estradiol Valerate [orange Book]
126. Estradiol Valerate [ep Monograph]
127. Estradiol Valerate For System Suitability
128. Ncgc00018166-02
129. Ncgc00018166-14
130. (1s,11s,14s,15s,10r)-5-hydroxy-15-methyltetracyclo[8.7.0.0<2,7>.0<11,15>]hepta Deca-2,4,6-trien-14-yl Pentanoate
131. Cas-979-32-8
132. Cpd000058346
133. Estradiol Valerate [usp Monograph]
134. B1506
135. Ditate-ds Component Estradiol Valerate
136. E0876
137. D01413
138. Ab00382980_15
139. Estradiol Valerate Component Of Ditate-ds
140. 979e328
141. A845765
142. Sr-01000003061
143. Q-201506
144. Q5401768
145. Sr-01000003061-3
146. 1,3,5(10)-estratrien-3,17beta-diol 17-valerate
147. Brd-k66766661-001-19-2
148. (17.beta.)-estra-1,3,5(10)-triene-3,17-diol 17-valerate
149. (17beta)-3-hydroxyestra-1(10),2,4-trien-17-yl Pentanoate
150. Estra-1,5(10)-triene-3,17-diol (17.beta.)-, 17-pentanoate
151. Estra-1,3,5(10)-triene-3,17-diol(17.beta.)-, 17-pentanoate
152. [(13s,17s)-3-hydroxy-13-methyl-6,7,8,9,11,12,14,15,16,17-decahydrocyclopenta[a]phenanthren-17-yl] Pentanoate
153. [(8r,9s,13s,14s,17s)-13-methyl-3-oxidanyl-6,7,8,9,11,12,14,15,16,17-decahydrocyclopenta[a]phenanthren-17-yl] Pentanoate
154. Pentanoic Acid [(8r,9s,13s,14s,17s)-3-hydroxy-13-methyl-6,7,8,9,11,12,14,15,16,17-decahydrocyclopenta[a]phenanthren-17-yl] Ester
| Molecular Weight | 356.5 g/mol |
|---|---|
| Molecular Formula | C23H32O3 |
| XLogP3 | 6 |
| Hydrogen Bond Donor Count | 1 |
| Hydrogen Bond Acceptor Count | 3 |
| Rotatable Bond Count | 5 |
| Exact Mass | 356.23514488 g/mol |
| Monoisotopic Mass | 356.23514488 g/mol |
| Topological Polar Surface Area | 46.5 Ų |
| Heavy Atom Count | 26 |
| Formal Charge | 0 |
| Complexity | 518 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 5 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 1 |
| 1 of 4 | |
|---|---|
| Drug Name | Delestrogen |
| PubMed Health | Estradiol (Injection) |
| Drug Classes | Endocrine-Metabolic Agent, Musculoskeletal Agent |
| Drug Label | DELESTROGEN (estradiol valerate injection, USP) contains estradiol valerate, a long-acting estrogen in sterile oil solutions for intramuscular use. These solutions are clear, colorless to pale yellow. Formulations (per mL): 10 mg estradiol valerate... |
| Active Ingredient | Estradiol valerate |
| Dosage Form | Injectable |
| Route | Injection |
| Strength | 20mg/ml; 40mg/ml; 10mg/ml |
| Market Status | Prescription |
| Company | Par Sterile Products |
| 2 of 4 | |
|---|---|
| Drug Name | Estradiol valerate |
| Drug Label | Estradiol valerate injection, USP contains estradiol valerate, a long-acting estrogen in sterile oil solutions for intramuscular use. These solutions are clear, colorless to pale yellow. Formulations (per mL): 10 mg estradiol valerate in a vehicle co... |
| Active Ingredient | Estradiol valerate |
| Dosage Form | Injectable |
| Route | Injection |
| Strength | 20mg/ml; 40mg/ml; 10mg/ml |
| Market Status | Prescription |
| Company | Luitpold; Sandoz |
| 3 of 4 | |
|---|---|
| Drug Name | Delestrogen |
| PubMed Health | Estradiol (Injection) |
| Drug Classes | Endocrine-Metabolic Agent, Musculoskeletal Agent |
| Drug Label | DELESTROGEN (estradiol valerate injection, USP) contains estradiol valerate, a long-acting estrogen in sterile oil solutions for intramuscular use. These solutions are clear, colorless to pale yellow. Formulations (per mL): 10 mg estradiol valerate... |
| Active Ingredient | Estradiol valerate |
| Dosage Form | Injectable |
| Route | Injection |
| Strength | 20mg/ml; 40mg/ml; 10mg/ml |
| Market Status | Prescription |
| Company | Par Sterile Products |
| 4 of 4 | |
|---|---|
| Drug Name | Estradiol valerate |
| Drug Label | Estradiol valerate injection, USP contains estradiol valerate, a long-acting estrogen in sterile oil solutions for intramuscular use. These solutions are clear, colorless to pale yellow. Formulations (per mL): 10 mg estradiol valerate in a vehicle co... |
| Active Ingredient | Estradiol valerate |
| Dosage Form | Injectable |
| Route | Injection |
| Strength | 20mg/ml; 40mg/ml; 10mg/ml |
| Market Status | Prescription |
| Company | Luitpold; Sandoz |
Estradiol valerate is commercially available as an intramuscular injection as the product Delestrogen and is indicated for the treatment of moderate to severe vasomotor symptoms and vulvovaginal atrophy due to menopause, for the treatment of hypoestrogenism due to hypogonadism, castration or primary ovarian failure, and for the treatment of advanced androgen-dependent carcinoma of the prostate (for palliation only). Estradiol valerate is also available in combination with [DB09123] as the commercially available product Natazia used for the prevention of pregnancy and for the treatment of heavy menstrual bleeding.
FDA Label
Estrogen mediates its effects across the body through potent agonism of the Estrogen Receptor (ER), which is located in various tissues including in the breasts, uterus, ovaries, skin, prostate, bone, fat, and brain. Estradiol binds to both subtypes of the Estrogen Receptor: Estrogen Receptor Alpha (ER) and Estrogen Receptor Beta (ER). Estradiol also acts as a potent agonist of G Protein-coupled Estrogen Receptor (GPER), which has recently been recognized as a major mediator of estradiol's rapid cellular effects.
Estrogens
Compounds that interact with ESTROGEN RECEPTORS in target tissues to bring about the effects similar to those of ESTRADIOL. Estrogens stimulate the female reproductive organs, and the development of secondary female SEX CHARACTERISTICS. Estrogenic chemicals include natural, synthetic, steroidal, or non-steroidal compounds. (See all compounds classified as Estrogens.)
Absorption
IM Injection: When conjugated with aryl and alkyl groups for parenteral administration, the rate of absorption of oily preparations is slowed with a prolonged duration of action, such that a single intramuscular injection of estradiol valerate or estradiol cypionate is absorbed over several weeks. Natazia: After oral administration of estradiol valerate, cleavage to 17-estradiol and valeric acid takes place during absorption by the intestinal mucosa or in the course of the first liver passage. This gives rise to estradiol and its metabolites, estrone and other metabolites. Maximum serum estradiol concentrations of 73.3 pg/mL are reached at a median of approximately 6 hours (range: 1.512 hours) and the area under the estradiol concentration curve [AUC(024h)] was 1301 pgh/mL after single ingestion of a tablet containing 3 mg estradiol valerate under fasted condition on Day 1 of the 28-day sequential regimen.
Route of Elimination
Estradiol, estrone and estriol are excreted in the urine along with glucuronide and sulfate conjugates.
Exogenous estrogens are metabolized using the same mechanism as endogenous estrogens. Estrogens are partially metabolized by cytochrome P450.
Estradiol enters target cells freely (e.g., female organs, breasts, hypothalamus, pituitary) and interacts with a target cell receptor. When the estrogen receptor has bound its ligand it can enter the nucleus of the target cell, and regulate gene transcription which leads to formation of messenger RNA. The mRNA interacts with ribosomes to produce specific proteins that express the effect of estradiol upon the target cell. Estrogens increase the hepatic synthesis of sex hormone binding globulin (SHBG), thyroid-binding globulin (TBG), and other serum proteins and suppress follicle-stimulating hormone (FSH) from the anterior pituitary. Increases in the down-stream effects of ER binding reverses some of the symptoms of menopause, which are primarily caused by a loss of estrogenic activity.
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Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3072
Submission : 1977-11-09
Status : Inactive
Type : II
Aspen API. More than just an API.
GDUFA
DMF Review : Complete
Rev. Date : 2015-01-06
Pay. Date : 2014-12-22
DMF Number : 12268
Submission : 1996-12-16
Status : Active
Type : II
Fareva is a one-stop-shop for API/HPAPI, OSD & Sterile products, is USFDA, EMA and PMDA-inspected and has multiple NDA & ANDA filings.
GDUFA
DMF Review : Complete
Rev. Date : 2017-06-02
Pay. Date : 2017-04-04
DMF Number : 23948
Submission : 2010-07-02
Status : Active
Type : II
GDUFA
DMF Review : N/A
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DMF Number : 4267
Submission : 1981-09-03
Status : Inactive
Type : II
GDUFA
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DMF Number : 24553
Submission : 2011-01-18
Status : Inactive
Type : II
GDUFA
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DMF Number : 25854
Submission : 2012-03-30
Status : Active
Type : II
GDUFA
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DMF Number : 39594
Submission : 2024-03-20
Status : Active
Type : II
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