Zydus gets USFDA nod for Dexamethasone Tablets USP, 0.5 mg, 0.75 mg, 1.5 mg, 4 mg and 6 mg and…
Dexamethasone is used to treat a number of different conditions, such as inflammation (swelling), severe allergies, adrenal…
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ANDA
Lupin gets US FDA nod for Dronedarone Tablets, USP
They are indicated to reduce the risk of hospitalisation for atrial fibrillation (AF) in patients in sinus rhythm with a history…
Masterclass with Dr Ajaz S Hussain, Pharma Expert | Regulatory Watch
SMART QbD in ANDAs: Enhancing Assurance of Generic Drug Quality
Lupin gets US FDA approval for Varenicline Tablets
They are indicated for use as an aid to smoking cessation treatment
Lupin launches Rocuronium Bromide Injection in US
It is indicated as an adjunct to general anesthesia to facilitate both rapid sequence and routine tracheal intubation, and to…
Zydus gets USFDA nod for Sugammadex Injection, 200 mg/2 mL and 500 mg/5 mL single-dose vial
Sugammadex Injection is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide…
Marksans Pharma gets US FDA nod for Esomeprazole Magnesium DR Capsules USP, 20 mg (OTC)
Esomeprazole is used to treat certain stomach and esophagus problems such as acid reflux and ulcer
Caplin Steriles gets USFDA approval for Norepinephrine Bitartrate Injection
Norepinephrine Bitartrate Injection is used for restoration of blood pressure in adult patients with acute hypotensive states
Lupin gets tentative US FDA approval for Dolutegravir Tablets for Oral Suspension
This product will be manufactured at Lupin’s Nagpur facility in India
Caplin Steriles gets USFDA nod for Cisatracurium Besylate injection
Cisatracurium Besylate Injection USP is a nondepolarising skeletal neuromuscular blocker, indicated as an adjunct to general…