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Alembic Pharma gets USFDA final approval for Doxepin Hydrochloride Capsules
expresspharma
April 25, 2021
Alembic Pharmaceuticals announced it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Doxepin Hydrochloride Capsules USP, 10 mg, 25 mg, 50 mg, 75 mg and 100 mg.
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Sun Pharma, Alembic recall products in the US market
expresspharma
April 20, 2021
Sun Pharma is recalling 91,211 pre-filled syringes of Ganirelix Acetate injection and 2,520 bottles of Metformin HCl Extended-Release tablets while Alembic is recalling 12,288 bottles of Telmisartan Tablets.
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Aleor Dermaceuticals gets tentative USFDA approval for Efinaconazole Topical Solution
expresspharma
April 09, 2021
It is indicated for the topical treatment of onychomycosis of the toenail(s) due to Trichophyton rubrum and Trichophyton mentagrophytes.
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Aleor Dermaceuticals gets USFDA nod for Nystatin and Triamcinolone Acetonide Cream
expresspharma
April 02, 2021
Alembic Pharmaceuticals announced that its joint venture Aleor Dermaceuticals has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Nystatin and Triamcinolone Acetonide Cream USP ...
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Alembic Recalls Telmisartan Tablets 20 mg
americanpharmaceuticalreview
April 01, 2021
Alembic Pharmaceuticals is voluntarily recalling one lot of Telmisartan Tablets, USP, 20 mg, packaged in 30-count bottles, Lot No. 1905005661 to the consumer level.
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Zydus Cadila, Alembic Pharma recall drugs in US
expresspharma
March 31, 2021
Zydus Pharmaceuticals (USA) is recalling four lots of Acyclovir Sodium Injection, 50 mg/mL, 10 mL and 20 mL vials, while Alembic Pharmaceuticals is recalling one lot of Telmisartan tablets, USP, 20 mg.
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Aleor Dermaceuticals gets USFDA Final nod for Testosterone Gel
expresspharma
March 04, 2021
Testosterone Gel is indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone.
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Alembic Pharma subsidiary, Alembic Global Holding SA gets USFDA final nod for Treprostinil injection
expresspharma
February 18, 2021
Treprostinil injection is indicated for the treatment of pulmonary arterial hypertension to diminish symptoms associated with exercise.
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Alembic Pharma gets final nod from USFDA for Midodrine Hydrochloride Tablets
expresspharma
January 25, 2021
Alembic Pharmaceuticals has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Midodrine Hydrochloride Tablets USP, 2.5 mg, 5 mg, and 10 mg.
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Alembic Pharma JV, Aleor Dermaceuticals gets tentative nod from USFDA for Testosterone Gel
expresspharma
November 25, 2020
It is indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone.