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Phenytoin Sodium

TRACKED

Anti-epileptic Agent

CASHSN
THERAPEUTIC AREAS
MOLECULE INTELLIGENCE SNAPSHOTlive
14
Manufacturers monitored
38
Intelligence briefs
3
Active regulatory actions
₹2,800 Cr
Est. India export value

INTELLIGENCE

Showing 1 of 1 briefs for Phenytoin Sodium
CLINICAL & PIPELINE·Drug Approval

Acella Pharmaceuticals Secures Latest FDA Labeling Approval for Generic Phenytoin Sodium Injectable

Acella Pharmaceuticals, LLC has received FDA approval for a labeling supplement for its generic Phenytoin Sodium injectable (ANDA040573) on October 2, 2024. This update reinforces the product's regulatory compliance and continued market presence, offering stability for procurement and supply chain operations. The 50mg/mL anticonvulsant remains a critical component in epilepsy management, ensuring ongoing access to an established, therapeutically equivalent treatment.

90-Day Activity
MKMeera Krishnan· Senior Regulatory Intelligence Analyst
2020-10-06