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Results For "Abbreviated-New-Drug-Application"

233 News Found

Senores Pharmaceuticals acquires 14 ANDAs from Dr. Reddy’s Laboratories
News | March 04, 2025

Senores Pharmaceuticals acquires 14 ANDAs from Dr. Reddy’s Laboratories

The basket acquired, comprises of 13 ANDAs, which are approved by the USFDA and 1 ANDA, which is pending approval from the USFDA


Caplin Steriles receives USFDA final approval for ANDA Brimonidine Tartrate and Timolol Maleate Ophthalmic Solution
Drug Approval | February 27, 2025

Caplin Steriles receives USFDA final approval for ANDA Brimonidine Tartrate and Timolol Maleate Ophthalmic Solution

Brimonidine Tartrate and Timolol Maleate Ophthalmic Solution is indicated for the reduction of elevated intraocular pressure


Lupin receives approval from USFDA for Ipratropium Bromide Nasal Solution
News | February 11, 2025

Lupin receives approval from USFDA for Ipratropium Bromide Nasal Solution

Ipratropium Bromide Nasal Solution is indicated for the symptomatic relief of rhinorrhea associated with allergic and nonallergic perennial rhinitis


Briefs: Caplin Point Laboratories, Hikal and Cipla
Drug Approval | February 10, 2025

Briefs: Caplin Point Laboratories, Hikal and Cipla

Hikal Limited announces the completion of the US Food and Drug Administration (USFDA) inspection at its Jigani unit, Bengaluru


Granules strengthens ADHD portfolio with FDA approval for Lisdexamfetamine Dimesylate capsules
Drug Approval | January 31, 2025

Granules strengthens ADHD portfolio with FDA approval for Lisdexamfetamine Dimesylate capsules

Lisdexamfetamine Dimesylate is indicated for the treatment of Attention Deficit Hyperactivity Disorder in adults and pediatric patients aged six years and older


Dr Reddy’s Labs Q3 FY25 profit up 2% YoY at Rs. 1,413 Cr
News | January 23, 2025

Dr Reddy’s Labs Q3 FY25 profit up 2% YoY at Rs. 1,413 Cr

The revenue from operations in Q3 FY25 is Rs. 8,358.6 crore, up 16% YoY


Caplin Steriles gets USFDA approval for Levetiracetam in Sodium Chloride Injection Infusion bags
Drug Approval | January 18, 2025

Caplin Steriles gets USFDA approval for Levetiracetam in Sodium Chloride Injection Infusion bags

This is the second Ready-To-Use Infusion bag (RTU Bags) ANDA drug product approved for Caplin Steriles


Alembic announces USFDA final approval for Brexpiprazole Tablets
Drug Approval | January 16, 2025

Alembic announces USFDA final approval for Brexpiprazole Tablets

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Rexulti Tablets


Briefs: Gandhar Oil Refinery India, FDC and Apitoria Pharma
Drug Approval | December 22, 2024

Briefs: Gandhar Oil Refinery India, FDC and Apitoria Pharma

FDC Ltd has received final approval from USFDA for the company's Abbreviated New Drug Application (ANDA) for Cefixime 400 mg Tablets