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Tag Archives: tablets

Cipla gets approval from USFDA for Valganciclovir Tablets

Cipla has received final approval for its Abbreviated New Drug Application (ANDA) for Valganciclovir Tablets 450mg from the United States Food and Drug Administration (USFDA). The company’s Valganciclovir Tablets 450mg is AB-rated generic therapeutic equivalent version of Roche’s Valcyte. It is a deoxynucleoside analogue cytomegalovirus (CMV) DNA polymerase inhibitor indicated ... Read More »

JB Chemicals gets USFDA’s nod for Midodrine Hydrochloride Tablets

JB Chemicals & Pharmaceuticals (JBCPL) has received an approval from the US Food and Drug Administration (USFDA) for Abbreviated New Drug Application (ANDA) for Midodrine Hydrochloride Tablets USP 2.5 mg, 5 mg and 10 mg. (for treatment of orthostatic hypotension). The company plans to commercialize this product in Q1 of ... Read More »

Zydus Cadila gets final approval from USFDA for Clobazam Tablets

Zydus Cadila has received the final approval from the US Food and Drug Administration (USFDA) to market Clobazam Tablets, (US RLD-ONFI Tablet), 10 mg and 20 mg. It will be manufactured at the group’s formulations manufacturing facility at SEZ, Ahmedabad. Clobazam is used in combination with other medications to treat ... Read More »

Zydus Cadila receives approval from USFDA for Colchicine Tablets

Zydus Cadila has received tentative approval from the US Food and Drug Administration (USFDA) to market Colchicine Tablets USP (US RLD – ColcyrsTM), 0.6 mg. It will be manufactured at the group’s formulations manufacturing facility at SEZ, Ahmedabad. This medication is used to prevent or treat attacks of gout (also ... Read More »

Dr. Reddy’s Lab launches Colesevelam HCI Tablets

Dr. Reddy’s Laboratories has launched Colesevelam HCI Tablets, USP, a therapeutic equivalent generic version of WELCHOL (colesevelam HCI) Tablets in the United States market approved by the US Food and Drug Administration (USFDA). The WELCHOL brand and generic had US sales of around $471 million MAT for the most recent ... Read More »