Alembic Pharmaceuticals receives USFDA final approval for Lamotrigine Extended-Release Tablets
Lamotrigine extended-release tablets are indicated for adjunctive therapy for primary generalized tonic-clonic seizures and partial-onset seizures
Lamotrigine extended-release tablets are indicated for adjunctive therapy for primary generalized tonic-clonic seizures and partial-onset seizures
Lupin's Pithampur Unit-1 gets Form 483 from USFDA with 3 observations
Paliperidone extended-release tablets are an atypical antipsychotic agent indicated for treatment of schizophrenia
He has been associated with Caplin Steriles Ltd., Mylan Laboratories Ltd., Caplin Point Laboratories Ltd., Strides Arcolab Ltd. and Novartis Vaccines and Diagnostics
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Pradaxa Capsules, 110 mg of Boehringer Ingelheim Pharmaceuticals
Nelarabine is a nucleoside metabolic inhibitor indicated for the treatment of patients with T-cell acute lymphoblastic leukemia
Indoco Remedies is addressing the observations comprehensively and will respond to the USFDA within the stipulated timeframe
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