Lupin gains USFDA approval for Loteprednol Etabonate Ophthalmic Gel
Being the exclusive first-to-file, Lupin is eligible for 180-day generic exclusivity
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Browsing Tag
ANDA approval
Zydus receives final USFDA approval for Eluxadoline Tablets, 75 mg and 100 mg
Eluxadoline is a mu-opioid receptor agonist, indicated in adults for the treatment of irritable bowel syndrome with diarrhoea…
Alembic Pharmaceuticals receive USFDA approval for Divalproex Sodium capsules
Approval marks Alembic’s 193rd final ANDA approval in the United States market
Alembic Pharmaceuticals receives U.S. FDA approval for Paliperidone extended-release tablets
Approval covers Paliperidone tablets for the treatment of schizophrenia and schizoaffective disorder
Indoco gains final ANDA approval for Lofexidine Tablets 0.18 mg
Indoco has been granted a CGT designation by the USFDA and being the first approved generic, is eligible for 180 days of CGT…
Granules India receives ANDA approval for Glycopyrrolate Oral Solution
It is bioequivalent and therapeutically equivalent to the reference listed drug, Cuvposa Oral Solution, 1 mg/5 mL of Merz…
Granules India gains ANDA approval for Trazodone tablets
The current annual US market for Trazodone tablets is approximately $128 million, according to MAT Jun 2024, IQVIA/IMS Health
Alembic gains USFDA final approval for Acitretin Capsules USP, 10 mg, 17.5 mg, and 25 mg
Acitretin Capsules USP, 10 mg, 17.5 mg, and 25 mg have an estimated market size of $ 21 million for twelve months ending June 2024…
Unichem gets USFDA nod for Doxazosin Tablets USP, 1 mg, 2 mg, 4 mg and 8 mg
Doxazosin tablets are indicated for the treatment of hypertension, to lower blood pressure
Eugia Pharma gets USFDA nod for posaconazole injection, 300 mg/16.7 mL, single-dose vial
The approved product has an estimated market size of $25.4 million for the twelve months ending October 2023, according to IQVIA