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Results For "reference-listed-drug"

185 News Found

Strides receives USFDA approval for generic Suprep bowel prep kit
Drug Approval | November 23, 2023

Strides receives USFDA approval for generic Suprep bowel prep kit

The Product will be manufactured at the company's facility in Bengaluru


Strides receives USFDA approval for Levetiracetam Oral Solution
Drug Approval | November 21, 2023

Strides receives USFDA approval for Levetiracetam Oral Solution

The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD) and is used in the treatment of seizures.


Lupin receives approval from US FDA for Ganirelix Acetate Injection
Drug Approval | November 20, 2023

Lupin receives approval from US FDA for Ganirelix Acetate Injection

The product will be manufactured at Lupin’s Nagpur facility in India


Granules India receives ANDA approval for Esomeprazole Magnesium Delayed-Release Capsules
Drug Approval | October 20, 2023

Granules India receives ANDA approval for Esomeprazole Magnesium Delayed-Release Capsules

Short-term treatment of heartburn and other symptoms associated with gastroesophageal reflux disease (GERD)


Marksans Pharma gets USFDA approval for Esomeprazole Magnesium delayed-release capsules
Drug Approval | October 05, 2023

Marksans Pharma gets USFDA approval for Esomeprazole Magnesium delayed-release capsules

This product is bioequivalent to the reference listed drug (RLD), Nexium 24 HR Delayed- Release Capsules, 2.0mg (OTC), of AstraZeneca Pharmaceuticals


Strides receives USFDA approval for Efavirenz, Emtricitabine & Tenofovir Disoproxil Fumurate tablets
Drug Approval | October 05, 2023

Strides receives USFDA approval for Efavirenz, Emtricitabine & Tenofovir Disoproxil Fumurate tablets

The approval adds to a list of products that Strides has approved in this therapeutic category through the PEPFAR pathway taking the total to 15 products


Strides receives USFDA approval for Icosapent Ethyl capsules
Drug Approval | October 04, 2023

Strides receives USFDA approval for Icosapent Ethyl capsules

The product is bioequivalent and therapeutically equivalent to the RLD, Vascepa of Amarin


Strides receives USFDA approval for Icosapent Ethyl Capsules
Drug Approval | September 25, 2023

Strides receives USFDA approval for Icosapent Ethyl Capsules

The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD)


Strides receives tentative USFDA approval for Dolutegravir tablets
Drug Approval | September 15, 2023

Strides receives tentative USFDA approval for Dolutegravir tablets

The products will be manufactured at the company's facility in Bengaluru


Strides receives USFDA approval for Sevelamer Carbonate for oral suspension
Drug Approval | September 11, 2023

Strides receives USFDA approval for Sevelamer Carbonate for oral suspension

The products will be manufactured at the company's facility in Bengaluru