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Results For "bioequivalent"

158 News Found

Granules India received ANDA approval for Guaifenesin and Pseudoephedrine Hydrochloride ER
Drug Approval | August 27, 2022

Granules India received ANDA approval for Guaifenesin and Pseudoephedrine Hydrochloride ER

Granules now have a total of 51 ANDA approvals from US FDA (49 Final approvals and 2 tentative approvals).


Eugia Pharma receives USFDA pproval for Medroxyprogesterone Acetate injectable suspension
Drug Approval | August 24, 2022

Eugia Pharma receives USFDA pproval for Medroxyprogesterone Acetate injectable suspension

The approved product has an estimated market size of around US $62 million for the twelve months ending June 2022 according to IQVIA


Strides receives USFDA approval for Naproxen Sodium OTC Softgel capsules
Drug Approval | August 19, 2022

Strides receives USFDA approval for Naproxen Sodium OTC Softgel capsules

The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Naproxen Sodium Capsules, 220 mg, of Bionpharma


Eugia Pharma receives USFDA approval for Vasopressin Injection USP
Drug Approval | August 16, 2022

Eugia Pharma receives USFDA approval for Vasopressin Injection USP

The approved product has an estimated market size of around US$ 606 million for the twelve months ending June 2022, according to IQVIA.


Strides receives USFDA approval for Cyclosporine Softgel Capsules
Drug Approval | August 03, 2022

Strides receives USFDA approval for Cyclosporine Softgel Capsules

Strides is the first Indian company to get approval for the product.


Strides receives USFDA approval for Ibuprofen OTC oral suspension
Drug Approval | June 12, 2022

Strides receives USFDA approval for Ibuprofen OTC oral suspension

Strides was granted a Competitive Generic Therapy (CGT) designation for its ANDA.


Eugia Pharma receives USFDA Approval for Leuprolide Acetate Injection
Drug Approval | June 08, 2022

Eugia Pharma receives USFDA Approval for Leuprolide Acetate Injection

he approved product has an estimated market size of US$ 83 million for the twelve months ending April 2022, according to IQVIA.


Strides receives USFDA approval for Ibuprofen Oral Suspension
Drug Approval | May 30, 2022

Strides receives USFDA approval for Ibuprofen Oral Suspension

The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Motrin Oral Suspension, 100 mg/5 mL, of McNeil Consumer Healthcare (McNeil)


Eugia Pharma receives USFDA approval for Pemetrexed
Drug Approval | May 26, 2022

Eugia Pharma receives USFDA approval for Pemetrexed

Pemetrexed for injection is indicated for the treatment of Antineoplastics (medications used to treat cancer)