Micro Labs` Generic Carboprost Tromethamine Receives Approval in the U.S.
Gland Pharma's Generic Carboprost Tromethamine Receives Approval in US
Alembic's Generic Carboprost Tromethamine Receives Approval in the U.S.
Caplin's Generic Carboprost Tromethamine Receives Approval in the U.S.
Long Grove's Generic Carboprost Tromethamine Receives Approval in the U.S.
BRIDGEWATER, N.J.--(BUSINESS WIRE)--Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal” or the “Company”) today announced the approval of four generic injectables products. Dexamethasone sodium phosphate injection, USP 10 mg/mL, azacitidine 100 mg, carboprost tromethamine injection, USP 250 mcg/mL, and atropine sulfate injection, USP 0.5 mg/5 mL, have received Abbreviated New Drug Application (ANDA) approval from the U.S. Food and Drug Administration (FDA). Dexamethasone and azacitidine are both currently on the FDA drug shortage list, and atroprine was granted Competitive Generic Therapy (CGT) status by the FDA.
Amneal's Generic Carboprost Tromethamine Receives Approval in the U.S.
Sunny Pharmtech`s Generic Carboprost Tromethamine Receives Approval in US
The US Food and Drug Administration (FDA) on Friday issued draft guidance detailing the performance criteria and testing methodologies device makers can use to support a 510(k) submission for magnetic resonance (MR) coils under the agency’s safety and performance based pathway.
DR REDDYS LABS LTD`s generic CARBOPROST TROMETHAMINE Receives Approval in US