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Results For "reference-listed-drug"

180 News Found

Strides receives USFDA approval for Fluoxetine Tabs 10 mg and 20 mg
Drug Approval | April 10, 2024

Strides receives USFDA approval for Fluoxetine Tabs 10 mg and 20 mg

The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD) Prozac Tablets of Eli Lilly


Aurobindo Pharma receives USFDA approval for Mometasone Furoate Monohydrate nasal spray
Drug Approval | March 20, 2024

Aurobindo Pharma receives USFDA approval for Mometasone Furoate Monohydrate nasal spray

The approved product has an estimated market size of US$ 44.5 million for the twelve months ending January 2024


Strides receives USFDA approval for Gabapentin Tablets
Drug Approval | March 06, 2024

Strides receives USFDA approval for Gabapentin Tablets

The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD) Neurontin Tablets, 600 mg and 800 mg, of Viatris Specialty


Aurobindo Pharma receives USFDA approval for Fingolimod Capsules, 0.5 mg
Drug Approval | March 02, 2024

Aurobindo Pharma receives USFDA approval for Fingolimod Capsules, 0.5 mg

The product will be launched in March 2024


Lupin launches Ganirelix Acetate Injection in US
News | February 16, 2024

Lupin launches Ganirelix Acetate Injection in US

It is indicated for the inhibition of premature luteinizing hormone (LH) surges in women undergoing controlled ovarian hyperstimulation


Strides receives USFDA approval for Pregabalin Capsules
Drug Approval | January 26, 2024

Strides receives USFDA approval for Pregabalin Capsules

The Pregabalin capsules has a market size of ~US$248 mn per IQVIA


Lupin receives USFDA approval for Loteprednol Etabonate Ophthalmic Suspension, 0.2%
Drug Approval | December 27, 2023

Lupin receives USFDA approval for Loteprednol Etabonate Ophthalmic Suspension, 0.2%

Loteprednol Etabonate Ophthalmic Suspension, 0.2%, is indicated for the temporary relief of the signs and symptoms of seasonal allergic conjunctivitis


Eugia Pharma Specialities receives USFDA final approval for Posaconazole Injection
Drug Approval | December 27, 2023

Eugia Pharma Specialities receives USFDA final approval for Posaconazole Injection

The product is expected to be launched in December 2023


Lupin receives USFDA approval for Allopurinol Tablets
Drug Approval | December 17, 2023

Lupin receives USFDA approval for Allopurinol Tablets

The product will be manufactured at Lupin's Pithampur facility in India


Granules India received ANDA approval for Pantoprazole Sodium Delayed-Release Tablets
Drug Approval | December 14, 2023

Granules India received ANDA approval for Pantoprazole Sodium Delayed-Release Tablets

Pantoprazole Sodium Delayed-Release Tablets are indicated for short-term treatment of Erosive Esophagitis associated with GERD