The approval is for Ibrutinib tablets 560 mg, 420 mg, 280 mg and 140 mg strengths
Sapropterin dihydrochloride powder for oral solution is available in 100 mg unit dose
Zydus has made its brand of Remdesivir, Remdac more affordable at Rs. 899 for a 100 mg lyophilized injection.
NATCO's partner BPI plans to launch 2.5 mg, 5 mg and 7.5 mg strengths of the product shortly within the next few weeks.
Penicillamine Tablets USP, 250 mg (RLD: Depen) had estimated annual sales of USD 5 million in the U.S. (IQVIA MAT December 2020).
The company will review FDA's response and decide on appropriate next steps soon.
Apremilast tablets are indicated for the treatment of adult patients with moderate to severe plaque psoriasis .
Droxidopa Capsules, 100 mg, 200 mg, and 300 mg, are indicated for the treatment of orthostatic dizziness
Fluphenazine Hydrochloride Tablets, USP are available in 1 mg, 2.5 mg, 5 mg, and 10 mg tablets in 100 bottle count sizes.
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