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Results For "therapeutically-equivalent"

190 News Found

Eugia Pharma receives USFDA approval for Amphotericin B Liposome for Injection
Drug Approval | November 19, 2022

Eugia Pharma receives USFDA approval for Amphotericin B Liposome for Injection

The product is expected to be launched by Q4 FY23.


Strides receives USFDA approval for Potassium Chloride Oral Solution
Drug Approval | November 19, 2022

Strides receives USFDA approval for Potassium Chloride Oral Solution

The approval further strengthens the Potassium Chloride franchise for the company.


Alembic receives USFDA final approval for Cyclophosphamide Capsules
Drug Approval | November 14, 2022

Alembic receives USFDA final approval for Cyclophosphamide Capsules

Cyclophosphamide Capsules, 25 mg and 50 mg, have an estimated market size of US$ 8 million for twelve months ending Sep 2022 according to IQVIA.


Alembic receives USFDA approval for Ketorolac Tromethamine Injection
Drug Approval | November 04, 2022

Alembic receives USFDA approval for Ketorolac Tromethamine Injection

Ketorolac Tromethamine is advised for the short-term management of moderately severe acute pain in adult patients


Alembic receives USFDA approval for Mesalamine ER Capsules
Drug Approval | November 03, 2022

Alembic receives USFDA approval for Mesalamine ER Capsules

Mesalamine Extended-Release Capsules are indicated for the maintenance of remission of ulcerative colitis in adults.


Alembic Pharma gets USFDA approval for Glycopyrrolate Injection USP
Drug Approval | November 01, 2022

Alembic Pharma gets USFDA approval for Glycopyrrolate Injection USP

This is the first injectable product approval from our General Sterile Facility (F-3) which was inspected in August, 2022.


Alembic Pharmaceuticals receives USFDA Final Approval for Chlorthalidone Tablets
News | August 31, 2022

Alembic Pharmaceuticals receives USFDA Final Approval for Chlorthalidone Tablets

Chlorthalidone Tablets USP, 25 mg and 50 mg, have an estimated market size of US $37 million for twelve months ending June, 2022 according to IQVIA


Alembic Pharmaceuticals receives USFDA final approval for Chlorthalidone Tablets USP
Drug Approval | August 29, 2022

Alembic Pharmaceuticals receives USFDA final approval for Chlorthalidone Tablets USP

he approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Hygroton Tablets, 25 mg and 50 mg, of Sanofi Aventis US. LLC (Sanofi).


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