Amantadine Oral Tablet

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Upsher-Smith Laboratories, Inc. (2014-10-22)
Oldest Current Product
2011-12-15
License(s)
ANDA
RxNORM
ORAL TABLET\AMANTADINE
FDAOB
ORAL\TABLET\AMANTADINE HYDROCHLORIDE
SPL Active
ORAL\TABLET\AMANTADINE HYDROCHLORIDE
SPL Moiety
ORAL\TABLET\AMANTADINE

product(s) by strength(s)

amantadine hydrochloride 100 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1008320111ANDAUpsher-Smith Laboratories, Inc.2011-12-15AMANTADINE HYDROCHLORIDEORALTABLETANDA07618663d9d4aa-5f92-45b0-98d0-d6ec38b727cb

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA076186AMANTADINE HYDROCHLORIDEUSL PHARMA INC2002-12-16ANDA076186_001
2NDA018101SYMMETRELTrueENDO PHARMACEUTICALS INCNDA018101_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1ANDA076186_001RXAMANTADINE HYDROCHLORIDE (100MG)ORALTABLETTrue2002-12-16AMANTADINE HYDROCHLORIDE
2NDA018101_001discontinuedAMANTADINE HYDROCHLORIDE (100MG)ORALTABLETFalseSYMMETREL

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
163d9d4aa-5f92-45b0-98d0-d6ec38b727cb (view SPL)Amantadine HCl TabletsprescriptionHuman PrescriptionUpsher-Smith Laboratories, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2014-10-223008320111

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