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DRUG PRODUCT COMPOSITIONS0
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1. 2-t-butylamino-1-(4-hydroxy-3-hydroxy-3-hydroxymethyl)phenylethanol
2. Albuterol
3. Proventil
4. Salbutamol
5. Sultanol
6. Ventolin
1. Salbutamol Sulfate
2. 51022-70-9
3. Salbutamol Hemisulfate
4. Proventil
5. Venetlin
6. Loftan
7. Albuterol Hemisulfate
8. Bronchospray
9. Ventolin
10. Accuneb
11. Proventil-hfa
12. Salbutamol Sulphate
13. Sch 13949w Sulfate
14. Proair
15. Ventolin Rotacaps
16. Proair Respiclick
17. Vospire Er
18. Sultanol
19. Ventilastin
20. Ecovent
21. Salbumol
22. Vospire
23. Albuterol Sulfate(2:1)
24. Albuterol Sulphate
25. 36519-31-0
26. Buventol
27. Salamol
28. Salbutamol (as Sulfate)
29. Sch 13949w Sulphate
30. Sch-13949w Sulphate
31. Sulbutamol (as Sulphate)
32. Sch-13949w Sulfate
33. 4-[2-(tert-butylamino)-1-hydroxyethyl]-2-(hydroxymethyl)phenol;sulfuric Acid
34. R03ac02
35. R03cc02
36. Aerolin
37. Airomir
38. 021sef3731
39. Nsc-289928
40. Aerotec
41. Aloprol
42. Amocasin
43. Broncodil
44. Dipulmin
45. Fartolin
46. Inspiryl
47. Emican
48. Proventil (tn)
49. Epaq
50. Broncho Inhalat
51. Huma-salmol
52. Ventolin Hfa
53. Dl-salbutamol Sulfate
54. (+-)-salbutamol Sulfate
55. 2-(tert-butylamino)-1-(4-hydroxy-3-hydroxymethylphenyl)ethanol Hemisulfate
56. 5-[2-(tert-butylamino)-1-hydroxyethyl]-2-hydroxybenzyl Alcohol Hemisulfate
57. Albuterol Sulfate [usan]
58. Proair Hfa
59. Ah-3365
60. Einecs 256-916-8
61. Salbutamol Hemisulfate Salt
62. Nsc 289928
63. Accuvent
64. Pediavent
65. Torpex
66. Volare
67. Albuterol Sulfate [usan:usp]
68. Ventolin Nebules
69. Ventolin Sulfate
70. Unii-021sef3731
71. Salbutamol Diskus
72. Salbutamoli Sulfas
73. Buventol Easyhaler
74. Proventil Repetabs
75. Pulvinal Salbutamol
76. Sulbutamol Sulphate
77. Proventil Repetabs, Solution, Syrup, And Tablets
78. Ventolin (tn)
79. Accuneb (tn)
80. Salbutamol Easyhaler
81. Ventolin Easy-breathe
82. Albuterol Sulfate,(s)
83. Albuterol Sulfate (usp)
84. Albuterol Sulfate- Bio-x
85. 1-(4-hydroxy-3-hydroxymethylphenyl)-2-(tert-butylamino)ethanol Sulfate
86. Salbutamol Sulfate (jp17)
87. Tbs-7
88. Schembl33279
89. Alpha(sup 1)-((tert-butylamino)methyl)-4-hydroxy-m-xylene-alpha,alpha'-diol Sulfate (2:1) (salt)
90. Albuterol Sulfate [mi]
91. Chebi:2550
92. (+-)-ysulfate(2:1)(salt)
93. Chembl1441059
94. Salbutamol Sulfate [jan]
95. Albuterol Sulfate [vandf]
96. Dtxsid10881180
97. Hms3263k18
98. Hms3266d17
99. Torpex (albuterol Sulfate)
100. Albuterol Sulfate [usp-rs]
101. Salbutamol Sulfate [mart.]
102. Bis((tert-butyl)(beta,3,4-trihydroxyphenethyl)ammonium) Sulphate
103. Salbutamol Sulfate [who-dd]
104. Salbutamol Sulfate [who-ip]
105. Tox21_501098
106. Mfcd00055200
107. Salbutamol Hemisulfate Salt, >=98%
108. Akos015994719
109. Albuterol Sulfate [green Book]
110. Albuterol Sulfate [orange Book]
111. Ccg-222402
112. Ks-5056
113. Lp01098
114. Tq-1016
115. Albuterol Sulfate [usp Impurity]
116. Salbutamol Sulfate [ep Impurity]
117. Salbutamol Sulphate (albuterol Sulphate)
118. Albuterol Sulfate [usp Monograph]
119. Duoneb Component Albuterol Sulfate
120. Ncgc00094370-01
121. Ncgc00261783-01
122. Salbutamol Sulfate [ep Monograph]
123. 1,3-benzenedimethanol, Alpha(sup 1)-(((1,1-dimethylethyl)amino)methyl)-4-hydroxy-, Sulfate (2:1) (salt)
124. 1,3-benzenedimethanol, Alpha1-(((1,1-dimethylethyl)amino)methyl)-4-hydroxy-, Sulfate (2:1) (salt)
125. Ba164388
126. Salbutamoli Sulfas [who-ip Latin]
127. Combivent Component Albuterol Sulfate
128. Albuterol Sulfate Component Of Duoneb
129. Eu-0101098
130. Ft-0650809
131. S0531
132. Salbutamol Sulfate 100 Microg/ml In Methanol
133. A51088
134. Albuterol Sulfate Component Of Combivent
135. D00683
136. S 5013
137. 022s709
138. A828402
139. Q27231480
140. Salbutamol Hemisulfate Salt, Vetranal(tm), Analytical Standard
141. Salbutamol Sulfate, British Pharmacopoeia (bp) Reference Standard
142. Salbutamol Sulfate, European Pharmacopoeia (ep) Reference Standard
143. Albuterol Sulfate, United States Pharmacopeia (usp) Reference Standard
144. Albuterol Sulfate, Pharmaceutical Secondary Standard; Certified Reference Material
145. Salbutamol Sulfate For System Suitability, European Pharmacopoeia (ep) Reference Standard
146. Salbutamol Sulphate (albuterol Sulphate) 1.0 Mg/ml In Methanol (as Free Base)
147. (+/-)-2-tert-butylamino-1-(4-hydroxy-3-hydroxymethylphenyl)ethanol Sulfate Salt (2:1)
148. .alpha.(sup 1)-((tert-butylamino)methyl)-4-hydroxy-m-xylene-.alpha.,.alpha.'-diol Sulfate (2:1) (salt)
149. .alpha.(sup 1)-((tert-butylamino)methyl)-4-hydroxy-m-xylene-.alpha.,.alpha.'-diol Sulphate (2:1) (salt)
150. 1,3-benzenedimethanol,.alpha.(sup 1)-(((1,1 Dimethylethyl)amino)methyl)-4-hydroxy-, Sulfate (2:1) (salt)
151. 1,3-benzenedimethanol,.alpha.(sup 1)-(((1,1 Dimethylethyl)amino)methyl)-4-hydroxy-, Sulphate (2:1) (salt)
152. 1,3-benzenedimethanol,.alpha.1-(((1,1-dimethylethyl)amino)methyl)-4-hydroxy-, Sulfate (2:1) (salt)
| Molecular Weight | 576.7 g/mol |
|---|---|
| Molecular Formula | C26H44N2O10S |
| Hydrogen Bond Donor Count | 10 |
| Hydrogen Bond Acceptor Count | 12 |
| Rotatable Bond Count | 10 |
| Exact Mass | 576.27166678 g/mol |
| Monoisotopic Mass | 576.27166678 g/mol |
| Topological Polar Surface Area | 228 Ų |
| Heavy Atom Count | 39 |
| Formal Charge | 0 |
| Complexity | 309 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 0 |
| Undefined Atom Stereocenter Count | 2 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 3 |
| 1 of 12 | |
|---|---|
| Drug Name | Accuneb |
| PubMed Health | Albuterol (By breathing) |
| Drug Classes | Bronchodilator |
| Drug Label | Albuterol Sulfate Inhalation Solution is a relatively selective beta2-adrenergic bronchodilator (see CLINICAL PHARMACOLOGY section below). Albuterol sulfate, the racemic form of albuterol, has the chemical name 1-[(tert-Butylamino)methyl]-4-hydroxy... |
| Active Ingredient | Albuterol sulfate |
| Dosage Form | Solution |
| Route | Inhalation |
| Strength | eq 0.021% base; eq 0.042% base |
| Market Status | Prescription |
| Company | Mylan Speclt |
| 2 of 12 | |
|---|---|
| Drug Name | Albuterol sulfate |
| PubMed Health | Albuterol |
| Drug Classes | Bronchodilator, Cardiovascular Agent |
| Drug Label | The active component of VENTOLIN HFA is albuterol sulfate, USP, the racemic form of albuterol and a relatively selective beta2-adrenergic bronchodilator. Albuterol sulfate has the chemical name 1-[(tert-butylamino)methyl]-4-hydroxy-m-xylene-,... |
| Active Ingredient | Albuterol sulfate |
| Dosage Form | Tablet, extended release; Tablet; Syrup; Solution |
| Route | Inhalation; Oral |
| Strength | eq 4mg base; eq 0.083% base; eq 2mg base; eq 0.021% base; eq 0.5% base; eq 2mg base/5ml; eq 0.042% base; eq 8mg base |
| Market Status | Prescription |
| Company | Watson Labs; Amneal Pharms; Vistapharm; Teva Pharms; Hi Tech Pharma; Ritedose; Actavis Mid Atlantic; Mutual Pharm; Teva; Vintage; Bausch And Lomb; Landela Pharm; Nephron; Mylan Speclt; Mylan |
| 3 of 12 | |
|---|---|
| Drug Name | Proair hfa |
| Active Ingredient | Albuterol sulfate |
| Dosage Form | Aerosol, metered |
| Route | Inhalation |
| Strength | eq 0.09mg base/inh |
| Market Status | Prescription |
| Company | Teva Branded Pharm |
| 4 of 12 | |
|---|---|
| Drug Name | Proventil-hfa |
| Active Ingredient | Albuterol sulfate |
| Dosage Form | Aerosol, metered |
| Route | Inhalation |
| Strength | eq 0.09mg base/inh |
| Market Status | Prescription |
| Company | 3m |
| 5 of 12 | |
|---|---|
| Drug Name | Ventolin hfa |
| Drug Label | Albuterol extended-release tablets contain albuterol sulfate, the racemic form of albuterol and a relatively selective beta2-adrenergic bronchodilator, in an extended-release formulation. Albuterol sulfate has the chemical name () 1-[(tert-butyla... |
| Active Ingredient | Albuterol sulfate |
| Dosage Form | Aerosol, metered |
| Route | Inhalation |
| Strength | eq 0.09mg base/inh |
| Market Status | Prescription |
| Company | Glaxo Grp |
| 6 of 12 | |
|---|---|
| Drug Name | Vospire er |
| Drug Label | The active ingredient of PROAIR HFA (albuterol sulfate) Inhalation Aerosol is albuterol sulfate, a racemic salt, of albuterol. Albuterol sulfate has the chemical name 1-[(tert-butylamino) methyl]-4-hydroxy-m-xylene-,'-diol sulfate (2:1) (salt),... |
| Active Ingredient | Albuterol sulfate |
| Dosage Form | Tablet, extended release |
| Route | Oral |
| Strength | eq 4mg base; eq 8mg base |
| Market Status | Prescription |
| Company | Dava Pharms |
| 7 of 12 | |
|---|---|
| Drug Name | Accuneb |
| PubMed Health | Albuterol (By breathing) |
| Drug Classes | Bronchodilator |
| Drug Label | Albuterol Sulfate Inhalation Solution is a relatively selective beta2-adrenergic bronchodilator (see CLINICAL PHARMACOLOGY section below). Albuterol sulfate, the racemic form of albuterol, has the chemical name 1-[(tert-Butylamino)methyl]-4-hydroxy... |
| Active Ingredient | Albuterol sulfate |
| Dosage Form | Solution |
| Route | Inhalation |
| Strength | eq 0.021% base; eq 0.042% base |
| Market Status | Prescription |
| Company | Mylan Speclt |
| 8 of 12 | |
|---|---|
| Drug Name | Albuterol sulfate |
| PubMed Health | Albuterol |
| Drug Classes | Bronchodilator, Cardiovascular Agent |
| Drug Label | The active component of VENTOLIN HFA is albuterol sulfate, USP, the racemic form of albuterol and a relatively selective beta2-adrenergic bronchodilator. Albuterol sulfate has the chemical name 1-[(tert-butylamino)methyl]-4-hydroxy-m-xylene-,... |
| Active Ingredient | Albuterol sulfate |
| Dosage Form | Tablet, extended release; Tablet; Syrup; Solution |
| Route | Inhalation; Oral |
| Strength | eq 4mg base; eq 0.083% base; eq 2mg base; eq 0.021% base; eq 0.5% base; eq 2mg base/5ml; eq 0.042% base; eq 8mg base |
| Market Status | Prescription |
| Company | Watson Labs; Amneal Pharms; Vistapharm; Teva Pharms; Hi Tech Pharma; Ritedose; Actavis Mid Atlantic; Mutual Pharm; Teva; Vintage; Bausch And Lomb; Landela Pharm; Nephron; Mylan Speclt; Mylan |
| 9 of 12 | |
|---|---|
| Drug Name | Proair hfa |
| Active Ingredient | Albuterol sulfate |
| Dosage Form | Aerosol, metered |
| Route | Inhalation |
| Strength | eq 0.09mg base/inh |
| Market Status | Prescription |
| Company | Teva Branded Pharm |
| 10 of 12 | |
|---|---|
| Drug Name | Proventil-hfa |
| Active Ingredient | Albuterol sulfate |
| Dosage Form | Aerosol, metered |
| Route | Inhalation |
| Strength | eq 0.09mg base/inh |
| Market Status | Prescription |
| Company | 3m |
| 11 of 12 | |
|---|---|
| Drug Name | Ventolin hfa |
| Drug Label | Albuterol extended-release tablets contain albuterol sulfate, the racemic form of albuterol and a relatively selective beta2-adrenergic bronchodilator, in an extended-release formulation. Albuterol sulfate has the chemical name () 1-[(tert-butyla... |
| Active Ingredient | Albuterol sulfate |
| Dosage Form | Aerosol, metered |
| Route | Inhalation |
| Strength | eq 0.09mg base/inh |
| Market Status | Prescription |
| Company | Glaxo Grp |
| 12 of 12 | |
|---|---|
| Drug Name | Vospire er |
| Drug Label | The active ingredient of PROAIR HFA (albuterol sulfate) Inhalation Aerosol is albuterol sulfate, a racemic salt, of albuterol. Albuterol sulfate has the chemical name 1-[(tert-butylamino) methyl]-4-hydroxy-m-xylene-,'-diol sulfate (2:1) (salt),... |
| Active Ingredient | Albuterol sulfate |
| Dosage Form | Tablet, extended release |
| Route | Oral |
| Strength | eq 4mg base; eq 8mg base |
| Market Status | Prescription |
| Company | Dava Pharms |
Adrenergic beta-2 Receptor Agonists
Compounds bind to and activate ADRENERGIC BETA-2 RECEPTORS. (See all compounds classified as Adrenergic beta-2 Receptor Agonists.)
Tocolytic Agents
Drugs that prevent preterm labor and immature birth by suppressing uterine contractions (TOCOLYSIS). Agents used to delay premature uterine activity include magnesium sulfate, beta-mimetics, oxytocin antagonists, calcium channel inhibitors, and adrenergic beta-receptor agonists. The use of intravenous alcohol as a tocolytic is now obsolete. (See all compounds classified as Tocolytic Agents.)
Bronchodilator Agents
Agents that cause an increase in the expansion of a bronchus or bronchial tubes. (See all compounds classified as Bronchodilator Agents.)
API SUPPLIERS
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USDMF
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30708
Submission : 2016-06-27
Status : Active
Type : II
Neuland Laboratories- A dedicated 100% API provider.
GDUFA
DMF Review : Complete
Rev. Date : 2013-09-26
Pay. Date : 2013-08-29
DMF Number : 16371
Submission : 2003-01-20
Status : Active
Type : II
Neuland Laboratories- A dedicated 100% API provider.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16104
Submission : 2002-08-16
Status : Active
Type : II
Neuland Laboratories- A dedicated 100% API provider.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10253
Submission : 1993-05-12
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6524
Submission : 1986-08-07
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-10-07
Pay. Date : 2015-09-24
DMF Number : 6522
Submission : 1986-08-07
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6886
Submission : 1987-01-21
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6885
Submission : 1987-01-20
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5885
Submission : 1985-06-14
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6143
Submission : 1985-01-04
Status : Inactive
Type : II
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CEP/COS
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API Imports and Exports
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Average Price (USD/KGS) |
Number of Transactions |
|---|
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Drugs in Development
Details:
The collaboration aims to further accelerate the clinical research program of Teva’s ICS-SABA (TEV-56248), albuterol/fluticasone combination, currently in Phase 3 clinical trials for patients with asthma.
Lead Product(s): Fluticasone Propionate,Salbutamol Sulphate
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: TEV-56248
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Launch Therapeutics
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration April 01, 2024
Lead Product(s) : Fluticasone Propionate,Salbutamol Sulphate
Therapeutic Area : Pulmonary/Respiratory Diseases
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Launch Therapeutics
Deal Size : Undisclosed
Deal Type : Collaboration
Details : The collaboration aims to further accelerate the clinical research program of Teva’s ICS-SABA (TEV-56248), albuterol/fluticasone combination, currently in Phase 3 clinical trials for patients with asthma.
Product Name : TEV-56248
Product Type : Small molecule
Upfront Cash : Undisclosed
April 01, 2024
Details:
The net proceeds will be used to further accelerate the clinical research program of Teva’s ICS-SABA (TEV-56248), albuterol/fluticasone combination, currently in Phase 3 clinical trials for patients with asthma.
Lead Product(s): Fluticasone Propionate,Salbutamol Sulphate
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: TEV-56248
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Abingworth
Deal Size: $150.0 million Upfront Cash: Undisclosed
Deal Type: Financing April 01, 2024
Lead Product(s) : Fluticasone Propionate,Salbutamol Sulphate
Therapeutic Area : Pulmonary/Respiratory Diseases
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Abingworth
Deal Size : $150.0 million
Deal Type : Financing
Details : The net proceeds will be used to further accelerate the clinical research program of Teva’s ICS-SABA (TEV-56248), albuterol/fluticasone combination, currently in Phase 3 clinical trials for patients with asth...
Product Name : TEV-56248
Product Type : Small molecule
Upfront Cash : Undisclosed
April 01, 2024
Details:
Airsupra (albuterol/budesonide) formerly known as PT027, is a first-in-class SABA/ICS. It is now available as the first and only FDA-approved anti-inflammatory rescue option for asthma.
Lead Product(s): Salbutamol Sulphate,Budesonide
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Airsupra
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 22, 2024
Lead Product(s) : Salbutamol Sulphate,Budesonide
Therapeutic Area : Pulmonary/Respiratory Diseases
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
AIRSUPRA® (albuterol/budesonide) Now Available as The First and Only FDA-Approved Anti-Inflammato...
Details : Airsupra (albuterol/budesonide) formerly known as PT027, is a first-in-class SABA/ICS. It is now available as the first and only FDA-approved anti-inflammatory rescue option for asthma.
Product Name : Airsupra
Product Type : Small molecule
Upfront Cash : Not Applicable
January 22, 2024
Details:
Albuterol sulfate inhalation powder is first and only breath-actuated, digital SABA inhaler, which is used for prevention of bronchospasm related to exercise-induced or reversible obstructive airway disease.
Lead Product(s): Salbutamol Sulphate
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Proair HFA-Generic
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 26, 2023
Lead Product(s) : Salbutamol Sulphate
Therapeutic Area : Pulmonary/Respiratory Diseases
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Amneal Submits Abbreviated New Drug Applications to U.S. FDA for Three Key Complex Generics
Details : Albuterol sulfate inhalation powder is first and only breath-actuated, digital SABA inhaler, which is used for prevention of bronchospasm related to exercise-induced or reversible obstructive airway disease.
Product Name : Proair HFA-Generic
Product Type : Small molecule
Upfront Cash : Not Applicable
July 26, 2023
Details:
Airsupra (albuterol/budesonide), is a first-in-class SABA/ICS rescue treatment for asthma in the US. It is an inhaled, fixed-dose combination of albuterol, a SABA, and budesonide, and has been developed in a pMDI using AstraZeneca’s Aerosphere delivery technology.
Lead Product(s): Salbutamol Sulphate,Budesonide
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Airsupra
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Avillion LLP
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 11, 2023
Lead Product(s) : Salbutamol Sulphate,Budesonide
Therapeutic Area : Pulmonary/Respiratory Diseases
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Avillion LLP
Deal Size : Not Applicable
Deal Type : Not Applicable
Airsupra (PT027) Approved in the US for Asthma
Details : Airsupra (albuterol/budesonide), is a first-in-class SABA/ICS rescue treatment for asthma in the US. It is an inhaled, fixed-dose combination of albuterol, a SABA, and budesonide, and has been developed in a pM...
Product Name : Airsupra
Product Type : Small molecule
Upfront Cash : Not Applicable
January 11, 2023
Details:
PT027 (albuterol/budesonide) is a potential first-in-class, pressurised metered-dose inhaler (pMDI), fixed-dose combination rescue medication in the US containing albuterol, a short-acting beta2-agonist (SABA), and budesonide, an anti-inflammatory inhaled corticosteroid (ICS).
Lead Product(s): Salbutamol Sulphate,Budesonide
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: PT027
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Avillion LLP
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 09, 2022
Lead Product(s) : Salbutamol Sulphate,Budesonide
Therapeutic Area : Pulmonary/Respiratory Diseases
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Avillion LLP
Deal Size : Not Applicable
Deal Type : Not Applicable
PT027 Recommended by FDA Advisory Committee as New Rescue Treatment for Asthma
Details : PT027 (albuterol/budesonide) is a potential first-in-class, pressurised metered-dose inhaler (pMDI), fixed-dose combination rescue medication in the US containing albuterol, a short-acting beta2-agonist (SABA),...
Product Name : PT027
Product Type : Small molecule
Upfront Cash : Not Applicable
November 09, 2022
Details:
Result showed adults and children aged 13 and older with uncontrolled asthma using ProAir Digihaler (albuterol sulfate) and integrated system had 85.3% higher odds of improving their asthma control after 3 months compared with those using standard-of-care albuterol inhalers.
Lead Product(s): Salbutamol Sulphate
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: ProAir Digihaler
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 07, 2022
Lead Product(s) : Salbutamol Sulphate
Therapeutic Area : Pulmonary/Respiratory Diseases
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Result showed adults and children aged 13 and older with uncontrolled asthma using ProAir Digihaler (albuterol sulfate) and integrated system had 85.3% higher odds of improving their asthma control after 3 mont...
Product Name : ProAir Digihaler
Product Type : Small molecule
Upfront Cash : Not Applicable
September 07, 2022
Details:
Study evaluated the effect of ProAir Digihaler System on asthma control versus standard of care as measured by Asthma Control Test, and explored use of the ProAir Digihaler System to help support patient-physician interactions for asthma management versus standard of care.
Lead Product(s): Salbutamol Sulphate
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: ProAir Digihaler
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 29, 2022
Lead Product(s) : Salbutamol Sulphate
Therapeutic Area : Pulmonary/Respiratory Diseases
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Teva to Present First Data Set from the CONNECT1 Clinical Trial on ProAir® Digihaler® (albuterol...
Details : Study evaluated the effect of ProAir Digihaler System on asthma control versus standard of care as measured by Asthma Control Test, and explored use of the ProAir Digihaler System to help support patient-physic...
Product Name : ProAir Digihaler
Product Type : Small molecule
Upfront Cash : Not Applicable
August 29, 2022
Details:
PT027 (Albuterol Sulfate) is a potential first-in-class inhaled, fixed-dose combination of albuterol, a short-acting beta2-agonist (SABA), and budesonide, an inhaled corticosteroid (ICS), in the US, being developed by Avillion and AstraZeneca under an agreement.
Lead Product(s): Salbutamol Sulphate,Budesonide
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: PT027
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: AstraZeneca
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 31, 2022
Lead Product(s) : Salbutamol Sulphate,Budesonide
Therapeutic Area : Pulmonary/Respiratory Diseases
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : AstraZeneca
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : PT027 (Albuterol Sulfate) is a potential first-in-class inhaled, fixed-dose combination of albuterol, a short-acting beta2-agonist (SABA), and budesonide, an inhaled corticosteroid (ICS), in the US, being devel...
Product Name : PT027
Product Type : Small molecule
Upfront Cash : Not Applicable
May 31, 2022
Details:
ProAir Digihaler (albuterol sulfate) inhalation powder is a prescription medicine used in people ≥4 years of age for the treatment or prevention of bronchospasm in people who have reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm.
Lead Product(s): Salbutamol Sulphate
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: ProAir Digihaler
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 17, 2022
Lead Product(s) : Salbutamol Sulphate
Therapeutic Area : Pulmonary/Respiratory Diseases
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Teva Announces New Findings Highlighting Potential of ProAir® Digihaler® (albuterol sulfate) Inh...
Details : ProAir Digihaler (albuterol sulfate) inhalation powder is a prescription medicine used in people ≥4 years of age for the treatment or prevention of bronchospasm in people who have reversible obstructive airwa...
Product Name : ProAir Digihaler
Product Type : Small molecule
Upfront Cash : Not Applicable
May 17, 2022
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Strides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.
RLD : No
TE Code :
Brand Name : ALBUTEROL SULFATE
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 4MG BASE
Approval Date : 1989-12-20
Application Number : 72860
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
Strides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.
RLD : No
TE Code :
Brand Name : ALBUTEROL SULFATE
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 2MG BASE
Approval Date : 1989-12-20
Application Number : 72860
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
Strides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.
RLD : No
TE Code :
Brand Name : VOSPIRE ER
Dosage Form : TABLET, EXTENDED RELEASE;ORAL
Dosage Strength : EQ 4MG BASE
Approval Date : 2002-09-26
Application Number : 76130
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
Strides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.
RLD : No
TE Code :
Brand Name : VOSPIRE ER
Dosage Form : TABLET, EXTENDED RELEASE;ORAL
Dosage Strength : EQ 8MG BASE
Approval Date : 2002-09-26
Application Number : 76130
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code :
Brand Name : ALBUTEROL SULFATE
Dosage Form : SOLUTION;INHALATION
Dosage Strength : EQ 0.021% BASE
Approval Date : 2007-09-25
Application Number : 77772
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code : AB2
Brand Name : ALBUTEROL SULFATE
Dosage Form : AEROSOL, METERED;INHALATION
Dosage Strength : EQ 0.09MG BASE/INH
Approval Date : 2024-05-21
Application Number : 212447
RX/OTC/DISCN : RX
RLD : No
TE Code : AB2
RLD : No
TE Code :
Brand Name : ALBUTEROL
Dosage Form : AEROSOL, METERED;INHALATION
Dosage Strength : 0.09MG/INH
Approval Date : 1997-08-19
Application Number : 73045
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : Yes
TE Code :
Brand Name : VENTOLIN
Dosage Form : SOLUTION;INHALATION
Dosage Strength : EQ 0.083% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 1992-04-23
Application Number : 19773
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : No
TE Code :
Brand Name : ALBUTEROL SULFATE
Dosage Form : SYRUP;ORAL
Dosage Strength : EQ 2MG BASE/5ML
Approval Date : 1998-01-30
Application Number : 74749
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code :
Brand Name : ALBUTEROL SULFATE
Dosage Form : AEROSOL, METERED;INHALATION
Dosage Strength : EQ 0.09MG BASE/INH
Approval Date : 2020-02-24
Application Number : 203760
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
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DOSAGE - AEROSOL, METERED;INHALATION - EQ 0.0...DOSAGE - AEROSOL, METERED;INHALATION - EQ 0.09MG BASE/INH
USFDA APPLICATION NUMBER - 20503
DOSAGE - SOLUTION;INHALATION - EQ 0.083% BASE...DOSAGE - SOLUTION;INHALATION - EQ 0.083% BASE;0.017% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20950
DOSAGE - AEROSOL, METERED;INHALATION - EQ 0.0...DOSAGE - AEROSOL, METERED;INHALATION - EQ 0.09MG BASE/INH
USFDA APPLICATION NUMBER - 20983
DOSAGE - AEROSOL, METERED;INHALATION - EQ 0.0...DOSAGE - AEROSOL, METERED;INHALATION - EQ 0.09MG BASE/INH
USFDA APPLICATION NUMBER - 21457
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