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FDA ANDA · ANDA204355

DICLOFENAC SODIUM/MISOPROSTOL DICLOFENAC-SODIUM-MISOPROSTOL

diclofenac sodium/misoprostol

Sponsor: MICRO LABS

APPLICATION
ANDA204355
TYPE
ANDA
ORIGINAL APPROVAL
2021-07-15
LATEST ACTION
2025-02-27
ROUTE
ORAL
DOSAGE FORM
TABLET, DELAYED RELEASE
MARKETING STATUS
Prescription

Products

DICLOFENAC SODIUM AND MISOPROSTOLPrescription
DICLOFENAC SODIUM 75MG, MISOPROSTOL 0.2MG · TABLET, DELAYED RELEASE · ORAL
DICLOFENAC SODIUM AND MISOPROSTOLPrescription
DICLOFENAC SODIUM 50MG, MISOPROSTOL 0.2MG · TABLET, DELAYED RELEASE · ORAL

Approval history

2025-02-27Labeling · Supplement 4 · standardAP
2024-03-29Labeling · Supplement 2 · standardAP
2024-03-29Labeling · Supplement 3 · standardAP
2024-03-29Labeling · Supplement 1 · standardAP
2021-07-15UNKNOWN · Original · standardAP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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