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ACTIVE SUBSTANCE / INN

DICLOFENAC SODIUM

Brand name(s): DICLOFENAC SODIUM, VOLTAREN-XR, DICLOFENAC SODIUM AND MISOPROSTOL, PENNSAID, VOLTAREN ARTHRITIS PAIN, VOLTAREN, ARTHROTEC
FDA LISTED
PRESCRIPTION
OVER-THE-COUNTER
DISCONTINUED
ANDA205143
NDA204623
ACTIVE SUBSTANCE
Diclofenac Sodium
REGULATORS
FDA
SPONSORS / MAH
AUROLIFE PHARMA LLC, ROXANE, ZYDUS PHARMS
TOTAL APPLICATIONS
10
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
DICLOFENAC SODIUMANDA076201DEXCEL LTDPrescription
VOLTARENNDA019201NOVARTISDiscontinued
DICLOFENAC SODIUMANDA204306AUROLIFE PHARMA LLCOver-the-counter
VOLTAREN-XRNDA020254NOVARTISDiscontinued
DICLOFENAC SODIUMANDA074391ROXANEDiscontinued
PENNSAIDNDA204623HORIZONDiscontinued
ARTHROTECNDA020607PFIZERPrescription
VOLTAREN ARTHRITIS PAINNDA022122HALEON US HOLDINGSOver-the-counter
DICLOFENAC SODIUM AND MISOPROSTOLANDA206771ZYDUS PHARMSDiscontinued
DICLOFENAC SODIUM AND MISOPROSTOLANDA205143YUNG SHIN PHARMPrescription

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