Alembic Pharma gets tentative nod from USFDA for Empagliflozin and Linagliptin tablets
Empagliflozin and Linagliptin tablet is indicated as an adjunct to diet and exercise to improve glycemic control in adults with…
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ANDA
Alembic Pharma receives USFDA approval for Vardenafil Hydrochloride tablets
They are indicated for the treatment of erectile dysfunction
Alembic Pharmaceuticals receives US FDA’s tentative approval for Empagliflozin and Metformin…
The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Synjardy Tablets of…
Cipla receives final approval for generic version of Shire’s Firazyr
Icatibant injection is indicated for the treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and…
Caplin Steriles signs distribution agreement with Xellia Pharmaceuticals
The former to license five of its injectable ANDAs to Xellia Pharmaceuticals for commercialisation in the US
Alembic Pharma gets US FDA nod for generic Doxycycline Hyclate tablets
The company's product is a generic version of Almirall's Acticlate tablets in the same strengths
Indoco receives US FDA approval for Succinylcholine Chloride Injection USP
Succinylcholine Chloride Injection is indicated as an adjunct to general anesthesia, to facilitate tracheal intubation, and to…
Laurus Labs receives USFDA approvals for two ANDAs under PEPFAR
These approvals enable Laurus Labs to launch both the products in several LMIC markets
Zydus Cadila receives tentative US FDA approval for Droxidopa Capsules
Droxidopa is used to treat symptoms of low blood pressure when standing, caused by a medical condition called neurogenic…
Zydus gets tentative USFDA approval for empagliflozin and metformin hydrochloride tablets
Zydus gets tentative USFDA approval for empagliflozin and metformin hydrochloride tablets