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General MedicationsEXTENDED RELEASEGeneric

OXCARBAZEPINE EXTENDED RELEASE TABLETS

OXCARBAZEPINE

Standard Dose
600MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: None (Tentative Approval)
Summary

Approval overview OXCARBAZEPINE EXTENDED RELEASE TABLETS is listed in Drugs@FDA under application 219404 (ANDA).

Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient OXCARBAZEPINE Form and strength TABLET;EXTENDED RELEASE - 600MG Sponsor LUPIN LIMITED Submission history Latest submission status date: 2025-06-06 00:00:00.

Structured Monograph

Clinical summary

Approval overview OXCARBAZEPINE EXTENDED RELEASE TABLETS is listed in Drugs@FDA under application 219404 (ANDA). Review priority: STANDARD Marketing status: None (Tentative Approval) Active ingredient OXCARBAZEPINE Form and strength TABLET;EXTENDED RELEASE - 600MG Sponsor LUPIN LIMITED Submission history Latest submission status date: 2025-06-06 00:00:00. Submission type: ORIG.

Monitoring

  • • Marketing status: None (Tentative Approval)
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.
OXCARBAZEPINE EXTENDED RELEASE TABLETS (OXCARBAZEPINE) | Drug Monograph | MedicHelpline