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ACTIVE SUBSTANCE / INN

SUVOREXANT

Brand name(s): BELSOMRA, SUVOREXANT
FDA LISTED
PRESCRIPTION
NONE (TENTATIVE APPROVAL)
ANDA219386
NDA204569
ACTIVE SUBSTANCE
Suvorexant
REGULATORS
FDA
SPONSORS / MAH
MERCK SHARP DOHME, HETERO LABS LTD UNIT III
TOTAL APPLICATIONS
2
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
SUVOREXANTANDA219386HETERO LABS LTD UNIT IIINone (Tentative Approval)
BELSOMRANDA204569MERCK SHARP DOHMEPrescription

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