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News about "Alembic Pharmaceuticals"
Alembic Pharmaceuticals Gets USFDA Final Approval for Divalproex Sodium Delayed-Release Capsules
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Depakote Sprinkle Capsules, 125 mg, of AbbVie Inc.
Alembic Pharmaceuticals | 16/01/2025 | By Aishwarya
Alembic Pharmaceuticals Gets USFDA Final Approval for Ivabradine Tablets
Ivabradine is a hyperpolarization-activated cyclic nucleotide-gated channel blocker indicated to reduce the risk of hospitalization for worsening heart failure in adult patients with stable, symptomatic chronic heart failure with reduced left ventricular ejection fraction.
Alembic Pharmaceuticals | 15/11/2024 | By Aishwarya
Alembic Pharmaceuticals Bags USFDA Final Approval for Diltiazem Hydrochloride Capsules
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Cardizem CD Extended-Release Capsules, 120 mg, 180 mg, 240 mg, 300 mg, and 360 mg, of Bausch Health US, LLC.
Alembic Pharmaceuticals | 12/11/2024 | By Aishwarya
Alembic Pharma Secures FDA Approval for Diltiazem Hydrochloride Capsules
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Dilacor XR Extended-Release Capsules, 120 mg, 180 mg, and 240 mg, of Allergan Sales LLC (Allergan).
Alembic Pharmaceuticals | 21/10/2024 | By Aishwarya | 154
Alembic Gets FDA Approval for Paliperidone Extended-Release Tablets
Paliperidone extended-release tablets are an atypical antipsychotic agent indicated for Treatment of schizophrenia and it is also indicated for treatment of schizoaffective disorder as monotherapy and as an adjunct to mood stabilizers and/or antidepressants.
Alembic Pharmaceuticals | 30/09/2024 | By Aishwarya
Alembic Pharma Receives Final FDA Approval for Albendazole Tablets
Albendazole tablets are indicated for the treatment of parenchymal neurocysticercosis due to active lesions caused by larval forms of the pork tapeworm, Taenia solium.
Alembic Pharmaceuticals | 05/09/2024 | By Aishwarya | 138
Alembic Gets FDA Approval for Betamethasone Valerate Foam
Betamethasone valerate foam, 0.12 percent, is a medium potency topical corticosteroid indicated for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses of the scalp.
Alembic Pharmaceuticals | 27/08/2024 | By Aishwarya | 156
Alembic Pharmaceuticals Gets FDA Approval for Dabigatran Etexilate Capsules
Dabigatran Etexilate Capsules 110 mg are indicated for prophylaxis of deep vein thrombosis and pulmonary embolism following hip replacement surgery. Refer label for a detailed indication.
Alembic Pharmaceuticals | 16/08/2024 | By Aishwarya
Alembic Pharma Secures US FDA Approval for Acitretin Capsules
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Soriatane Capsules, 10 mg, 17.5 mg, and 25 mg, of Stiefel Laboratories, Inc. (Stiefel).
Alembic Pharmaceuticals | 12/08/2024 | By Aishwarya | 110
Alembic Pharma Gets USFDA Final Approval for Nelarabine Injection
Alembic Pharmaceuticals has secured final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Nelarabine Injection, 250 mg/50 mL (5 mg/mL) (Single-Dose Vial).
Alembic Pharmaceuticals | 05/08/2024 | By Aishwarya | 134
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