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Results For "ANDA-approval"

201 News Found

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


Eugia Pharma receives USFDA approval for Budesonide Inhalation Suspension
Drug Approval | December 01, 2023

Eugia Pharma receives USFDA approval for Budesonide Inhalation Suspension

The product is expected to be launched in FY25


Caplin Steriles receives EIR from US FDA
Drug Approval | September 05, 2023

Caplin Steriles receives EIR from US FDA

The inspection classification was determined by the agency as Voluntary Action Indicated


Ajanta Pharma receives USFDA for Topiramate Extended Release Capsules
Drug Approval | August 31, 2023

Ajanta Pharma receives USFDA for Topiramate Extended Release Capsules

Topiramate is the generic version of Supernus Pharmaceuticals’ Trokendi XR


Briefs: J B Chemicals & Pharmaceuticals updates and Torrent Pharmaceuticals
Drug Approval | August 24, 2023

Briefs: J B Chemicals & Pharmaceuticals updates and Torrent Pharmaceuticals

The drug will be manufactured at JB Pharma's formulation manufacturing facility in Panoli, Gujarat


Granules India announces approval for Acetaminophen and Ibuprofen Tablets
Drug Approval | July 14, 2023

Granules India announces approval for Acetaminophen and Ibuprofen Tablets

This product will be launched through Granules Consumer Health (GCH) division


Alembic Pharmaceuticals receives USFDA approvals for 5 products in Q1FY24
Drug Approval | July 03, 2023

Alembic Pharmaceuticals receives USFDA approvals for 5 products in Q1FY24

Alembic has a cumulative total of 184 ANDA approvals (159 final approvals and 25 tentative approvals) from USFDA.