Granules India gets ANDA approval for Gabapentin tablets
Gabapentin tablets are indicated for management of postherpetic neuralgia in adults; and as an adjunctive therapy in the treatment…
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Browsing Tag
ANDA
Lupin gets tentative US FDA approval for Valbenazine capsules
Valbenazine is indicated for the treatment of tardive dyskinesia (uncontrollable movement of face, tongue, or other body parts)
NATCO announces ANDA filing for generic olaparib tablets in US
Olaparib is indicated primarily for certain forms of ovarian, breast, pancreatic and prostrate cancer
Sun Pharma gets US FDA nod for generic lenalidomide capsules
The respective product approval is based on Revlimid Capsules, 5 mg, 10 mg, 15 mg, 25 mg and 2.5 mg, 20 mg as a reference product
Lupin gets USFDA approval for Glycopyrrolate Injection, USP
The product marks the first approval from Lupin’s new injectable facility in Nagpur, India
Alembic Pharma gets USFDA nod for Fulvestrant injection, 250 mg/5 mL per single-dose syringe
Fulvestrant injection is an estrogen receptor antagonist indicated for the treatment of breast cancer
Lupin gets US FDA approval for Brivaracetam Tablets
The product will be manufactured at Lupin’s facility in Nagpur, India
US FDA gives final approval to Alembic Pharma’s Desonide cream
The approved ANDA is therapeutically equivalent to the Reference Listed Drug (RLD) product, Desonide Cream, 0.05%, of Padagis
US FDA approves Ketorolac Tromethamine injection by Alembic Pharma
This is the second injectable product approval from the company's General Sterile Facility (F-3) which was inspected in August,…
US FDA approves Lupin’s Mirabegron extended-release tablets
The product will be manufactured at Lupin’s facility in Nagpur