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Aurobindo Pharma Ltd (IN:AUROPHARMA)
:AUROPHARMA
Methacholine Chloride, Albuterol Sulfate Hfa 0.09 Mg (Reference), Albuterol Sulfate Hfa 0.18 Mg (Reference), Albuterol Sulfate Hfa 0.09 Mg (Test), Albuterol Sulfate Hfa 0.18 Mg (Test)
Bronchial Asthma
Phase III
Withdrawn
Pharmacodynamic Bioequivalence Study of Albuterol Sulfate Inhalation Aerosol, 0.09 mg Albuterol Base/ Inhalation
Mar 15, 2022
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Adapalene 0.1% Gel, Differin 0.1% Topical Gel
Acne Vulgaris
Phase III
Withdrawn
Clinical Endpoint Bioequivalence Study of Adapalene Gel 0.1%
Mar 30, 2020
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Test Product, Reference Product
Bronchial Asthma
Phase III
Completed
Clinical Pharmacodynamic Bioequivalence Study of Beclomethasone Dipropionate 40 mcg INH
Aug 05, 2019
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Amphotericin B Liposome, Ambisome (Amphotericin B) Liposome
Visceral Leishmaniasis
Phase I
Completed
Steady State Global Bioequivalence Study of Amphotericin B Liposome for Injection 50 mg/ Vial in Fed Condition
Aug 06, 2018
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Amlodipine - Reference, Amlodipine Odt - Test
Healthy Volunteers
Phase I
Completed
Bioavailability Study Comparing 10 mg Amlodipine Besylate Orally Disintegrating Tablets (ODT) And 10 mg Amlodipine Besylate Capsules
Mar 10, 2010
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Amlodipine - Reference, Amlodipine Odt - Test
Healthy Volunteers
Phase I
Completed
Bioavailability Study Comparing 10 Mg Amlodipine Besylate Orally Disintegrating Tablet (ODT) And 10 Mg Amlodipine Besylate Tablets
Mar 08, 2010
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FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases:
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does Aurobindo Pharma Ltd (AUROPHARMA) have in its pipeline
AUROPHARMA is currently developing the following drugs: Methacholine Chloride, Albuterol Sulfate Hfa 0.09 Mg (Reference), Albuterol Sulfate Hfa 0.18 Mg (Reference), Albuterol Sulfate Hfa 0.09 Mg (Test), Albuterol Sulfate Hfa 0.18 Mg (Test), Adapalene 0.1% Gel, Differin 0.1% Topical Gel, Test Product, Reference Product. These drug candidates are in various stages of clinical development as the company works toward FDA approval.