Ivermectin Oral Tablet

Brand(s)
Stromectol
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Merck Sharp & Dohme Corp. (2010-05-31)
Oldest Current Product
1996-11-22
License(s)
NDA, ANDA
RxNORM
ORAL TABLET\IVERMECTIN
FDAOB
ORAL\TABLET\IVERMECTIN
SPL Active
ORAL\TABLET\IVERMECTIN
SPL Moiety
ORAL\TABLET\IVERMECTIN

product(s) by strength(s)

ivermectin 3 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000060032StromectolNDAMerck Sharp & Dohme Corp.1996-11-22IVERMECTINORALTABLETNDA050742681888c9-af79-4b7d-ae80-c3f4f6f1effd

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1427990806ANDAEdenbridge Pharmaceuticals, Llc2014-11-15IVERMECTINORALTABLETANDA204154847a1dd7-d65b-4a0e-a67d-d90392059dac

application(s)

#idtitleapplicantapprovedapproved drug
1ANDA204154IVERMECTINEDENBRIDGE PHARMACEUTICALS LLC2014-10-24ANDA204154_001
2NDA050742STROMECTOLMERCK SHARP AND DOHME CORP1996-11-22NDA050742_001, NDA050742_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA204154_001RXIVERMECTIN (3MG)ORALTABLETFalseAB2014-10-24IVERMECTIN
2NDA050742_001discontinuedIVERMECTIN (6MG)ORALTABLETFalse1996-11-22STROMECTOL
3NDA050742_002RXIVERMECTIN (3MG)ORALTABLETTrueAB1998-10-08STROMECTOL

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1681888c9-af79-4b7d-ae80-c3f4f6f1effd (view SPL)STROMECTOL (IVERMECTIN)TABLETSprescriptionHuman PrescriptionMerck Sharp & Dohme Corp.MANUFACTURE2010-05-3110000060032
2847a1dd7-d65b-4a0e-a67d-d90392059dac (view SPL)Ivermectin Tablets USP, 3mg(IVERMECTIN)prescriptionHuman PrescriptionEdenbridge Pharmaceuticals, Llc2014-11-042427990806

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII