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Strides gets USFDA nod for Oxybutynin Chloride Tablets expresspharma
December 21, 2020
Strides Pharma Science announced that its step-down wholly-owned subsidiary, Strides Pharma Global, Singapore, has received approval for Oxybutynin Chloride Tablets USP, 5 mg from the United States Food & Drug Administration (USFDA).
Alembic Pharma gets USFDA final approval for Asenapine Sublingual Tablets expresspharma
December 14, 2020
Asenapine is an atypical antipsychotic indicated for bipolar I disorder as adjunctive treatment to lithium or valproate in adults.
Glenmark Pharma gets ANDA approval for Tacrolimus Capsules expresspharma
November 12, 2020
It is the generic version of Prograf Capsules of Astellas Pharm.
Alembic Pharma gets USFDA tentative nod for Palbociclib Capsules expresspharma
November 10, 2020
Alembic Pharma announced that it has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Palbociclib Capsules, 75 mg, 100 mg, and 125 mg.
Alembic Pharma gets US FDA approval for timolol maleate expresspharma
October 27, 2020
Alembic Pharmaceuticals has received final approval from the US Food & Drug Administration (US FDA) for its Abbreviated New Drug Application (ANDA) timolol maleate ophthalmic gel forming solution, 0.25 per cent and 0.5 per cent.
Alembic Pharmaceuticals gets USFDA nod for Fenofibrate Capsules expresspharma
October 22, 2020
They are indicated as adjunctive therapy to diet for the reduction of LDL-C, Total-C, Triglycerides and Apo B in adult patients with primary hypercholesterolemia, mixed dyslipidemia and hypertriglyceridemia.
Aleor Dermaceuticals gets USFDA nod for Tavaborole Topical Solution expresspharma
October 22, 2020
It is an oxaborole antifungal indicated for the treatment of onychomycosis of the toenails due to Trichophyton rubrum or Trichophyton mentagrophytes.
MSN group gets US FDA nod for dimethyl fumarate capsules expresspharma
October 10, 2020
Dimethyl fumarate is a prescription medicine used to treat relapsing forms of multiple sclerosis in adults.
Glenmark Pharmaceuticals gets ANDA approval for multiple sclerosis drug expresspharma
October 10, 2020
Glenmark’s current portfolio consists of 164 products authorised for distribution in the US marketplace and 46 ANDA’s pending approval with the US FDA.
Aleor Dermaceuticals receives USFDA nod for Desonide lotion expresspharma
August 27, 2020
It indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

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