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APP Pharmaceuticals' Abbreviated New Drug Application for 20 mg/mL caffeine citrate oral solution has been approved by the US FDA.
Inpharma Weekly
◽
10.2165/00128413-200816250-00066
◽
2008
◽
Vol &NA;
(1625)
◽
pp. 22
Author(s):
&NA;
Keyword(s):
Drug Application
◽
Oral Solution
◽
New Drug
◽
The Us
◽
Caffeine Citrate
◽
Us Fda
◽
New Drug Application
Download Full-text
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Cited By
References
Hi-Tech Pharmacal's Abbreviated New Drug Application (ANDA) for fluticasone propionate nasal spray 50??g has been granted final approval by the US FDA.
Inpharma Weekly
◽
10.2165/00128413-200816220-00088
◽
2008
◽
Vol &NA;
(1622)
◽
pp. 22
Author(s):
&NA;
Keyword(s):
Fluticasone Propionate
◽
Nasal Spray
◽
Drug Application
◽
Final Approval
◽
New Drug
◽
The Us
◽
Us Fda
◽
New Drug Application
Download Full-text
The US FDA has granted tentative approval for Mylan Pharmaceuticals' Abbreviated New Drug Application for delayed-release rabeprazole
Inpharma Weekly
◽
10.2165/00128413-200615220-00050
◽
2006
◽
Vol &NA;
(1522)
◽
pp. 18
Author(s):
&NA;
Keyword(s):
Drug Application
◽
New Drug
◽
Delayed Release
◽
The Us
◽
Tentative Approval
◽
Us Fda
◽
New Drug Application
Download Full-text
The US FDA has granted tentative approval to Teva Pharmaceutical's Abbreviated New Drug Application (ANDA) for lansoprazole.
Inpharma Weekly
◽
10.2165/00128413-200816230-00071
◽
2008
◽
Vol &NA;
(1623)
◽
pp. 19
Author(s):
&NA;
Keyword(s):
Drug Application
◽
New Drug
◽
The Us
◽
Tentative Approval
◽
Us Fda
◽
New Drug Application
Download Full-text
Banner Pharmacaps has received approval from the US FDA for its Abbreviated New Drug Application (ANDA) for nimodipine 30mg soft gelatin capsules.
Inpharma Weekly
◽
10.2165/00128413-200816230-00057
◽
2008
◽
Vol &NA;
(1623)
◽
pp. 17
◽
Cited By ~ 1
Author(s):
&NA;
Keyword(s):
Drug Application
◽
Gelatin Capsules
◽
New Drug
◽
Soft Gelatin Capsules
◽
The Us
◽
Us Fda
◽
New Drug Application
Download Full-text
Endo Pharmaceuticals received a "not approvable" letter from the US FDA regarding their supplemental New Drug Application for frovatriptan [Frova]
Inpharma Weekly
◽
10.2165/00128413-200716090-00069
◽
2007
◽
Vol &NA;
(1609)
◽
pp. 23
Author(s):
&NA;
Keyword(s):
Drug Application
◽
Approvable Letter
◽
New Drug
◽
The Us
◽
Us Fda
◽
New Drug Application
Download Full-text
Teva Pharmaceutical's Abbreviated New Drug Application (ANDA) for pravastatin 80mg tablets has been granted final approval by the US FDA.
Inpharma Weekly
◽
10.2165/00128413-200816220-00090
◽
2008
◽
Vol &NA;
(1622)
◽
pp. 22
Author(s):
&NA;
Keyword(s):
Drug Application
◽
Final Approval
◽
New Drug
◽
The Us
◽
Us Fda
◽
New Drug Application
Download Full-text
Mylan Pharmaceuticals' Abbreviated New Drug Application for fluoxetine 10mg and 20mg capsules has been granted tentative approval by the US FDA
Inpharma Weekly
◽
10.2165/00128413-200615540-00070
◽
2006
◽
Vol &NA;
(1554)
◽
pp. 22
Author(s):
&NA;
Keyword(s):
Drug Application
◽
New Drug
◽
The Us
◽
Tentative Approval
◽
Us Fda
◽
New Drug Application
Download Full-text
The US FDA should consider increasing the number of patients required for new drug application clinical trials
Reactions Weekly
◽
10.2165/00128415-199907520-00004
◽
1999
◽
Vol &NA;
(752)
◽
pp. 2
Author(s):
&NA;
Keyword(s):
Clinical Trials
◽
Drug Application
◽
New Drug
◽
Number Of Patients
◽
The Us
◽
Us Fda
◽
New Drug Application
Download Full-text
APP Pharmaceuticals' Abbreviated New Drug Application (ANDA) for injectable polymyxin B (500 000 units/vial) has been approved by the US FDA.
Inpharma Weekly
◽
10.2165/00128413-200816220-00086
◽
2008
◽
Vol &NA;
(1622)
◽
pp. 21
Author(s):
&NA;
Keyword(s):
Drug Application
◽
Polymyxin B
◽
New Drug
◽
The Us
◽
Us Fda
◽
New Drug Application
Download Full-text
Merck & Co has received a not approvable letter for its New Drug Application for OTC lovastatin [Mevacor OTC] 20mg from the US FDA.
Inpharma Weekly
◽
10.2165/00128413-200816230-00063
◽
2008
◽
Vol &NA;
(1623)
◽
pp. 18
Author(s):
&NA;
Keyword(s):
Drug Application
◽
Approvable Letter
◽
New Drug
◽
The Us
◽
Us Fda
◽
New Drug Application
Download Full-text
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