Lupin receives tentative approval from USFDA for Oxcarbazepine ER Tablets
Oxcarbazepine ER Tablets (RLD Oxtellar XR) had estimated annual sales of US$ 206 million in the US (IQVIA MAT April 2025)
Oxcarbazepine ER Tablets (RLD Oxtellar XR) had estimated annual sales of US$ 206 million in the US (IQVIA MAT April 2025)
Rifaximin tablets had annual sales of US$ 2672.9 mn in the United States (IQVIA MAT March 2025)
Isotretinoin capsules are indicated to treat severe, disfiguring nodular acne
Haloperidol Decanoate Injection indicated for the treatment of patients with schizophrenia who require prolonged parenteral antipsychotic therapy
Tolvaptan Tablets are indicated to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease
Glatiramer Acetate is the generic version of Copaxone 20 mg/ml, 40 mg/ml, Single-Dose Prefilled Syringes
This outcome reflects Innoxel Lifesciences' ongoing commitment to maintaining the highest standards of quality, compliance, and regulatory excellence
The FDA issued Form 483 with one observation related to building and facility management
Niacin is indicated to reduce elevated total cholesterol, LDL cholesterol, apolipoprotein B and triglycerides (TG)
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