Rimantadine Oral Tablet

Brand(s)
Flumadine
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Caraco Pharma, Inc. (2010-11-19)
Oldest Current Product
2005-04-01
License(s)
NDA, ANDA
RxNORM
ORAL TABLET\RIMANTADINE
FDAOB
ORAL\TABLET\RIMANTADINE HYDROCHLORIDE
SPL Active
ORAL\TABLET, FILM COATED\RIMANTADINE HYDROCHLORIDE
ORAL\TABLET\RIMANTADINE HYDROCHLORIDE
SPL Moiety
ORAL\TABLET, FILM COATED\RIMANTADINE
ORAL\TABLET\RIMANTADINE

product(s) by strength(s)

rimantadine hydrochloride 100 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1497080521FlumadineNDACaraco Pharma, Inc.2009-09-22RIMANTADINE HYDROCHLORIDEORALTABLETNDA0196491597dc56-a4ae-4906-ba55-f268b3cb8262

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001151911ANDAGlobal Pharmaceuticals2005-04-01RIMANTADINE HYDROCHLORIDEORALTABLET, FILM COATEDANDA07613249f7d69a-820b-4c75-a31d-b2104c019c12

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1165900202ANDAStat Rx Usa Llc2005-04-01RIMANTADINE HYDROCHLORIDEORALTABLET, FILM COATED001151911ANDA07613208d7b0df-a353-49a0-92ac-64028d4084b7
2529590305ANDAH.J. Harkins Company, Inc.2005-04-01RIMANTADINE HYDROCHLORIDEORALTABLET001151911ANDA07613248842cd7-2d78-455a-a688-b148347b6dd5
3636293552ANDABryant Ranch Prepack2005-04-01RIMANTADINE HYDROCHLORIDEORALTABLET, FILM COATED001151911ANDA076132209051ce-117e-4459-8ac8-c08edf09b9ad
4681512103ANDACarilion Materials Management2005-04-01RIMANTADINE HYDROCHLORIDEORALTABLET, FILM COATED001151911ANDA076132a1d00c0f-ec9d-4849-b3b5-9c0dff07026c

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA075916RIMANTADINE HYDROCHLORIDETrueCOREPHARMA LLC2001-11-02ANDA075916_001
2ANDA076132RIMANTADINE HYDROCHLORIDEIMPAX LABORATORIES INC2002-08-30ANDA076132_001
3ANDA076375RIMANTADINE HYDROCHLORIDETrueACTAVIS ELIZABETH LLC2003-01-14ANDA076375_001
4NDA019649FLUMADINECARACO PHARMACEUTICAL LABORATORIES LTD1993-09-17NDA019649_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA075916_001discontinuedRIMANTADINE HYDROCHLORIDE (100MG)ORALTABLETFalse2001-11-02RIMANTADINE HYDROCHLORIDE
2ANDA076132_001RXRIMANTADINE HYDROCHLORIDE (100MG)ORALTABLETFalseAB2002-08-30RIMANTADINE HYDROCHLORIDE
3ANDA076375_001discontinuedRIMANTADINE HYDROCHLORIDE (100MG)ORALTABLETFalse2003-01-14RIMANTADINE HYDROCHLORIDE
4NDA019649_001RXRIMANTADINE HYDROCHLORIDE (100MG)ORALTABLETTrueAB1993-09-17FLUMADINE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
108d7b0df-a353-49a0-92ac-64028d4084b7 (view SPL)RIMANTADINE HYDROCHLORIDE TABLETS, 100 MGprescriptionHuman PrescriptionStat Rx Usa Llcrelabel, repack2012-08-141165900202
21597dc56-a4ae-4906-ba55-f268b3cb8262 (view SPL)prescriptionHuman PrescriptionCaraco Pharma, Inc.MANUFACTURE2010-11-193497080521
3209051ce-117e-4459-8ac8-c08edf09b9ad (view SPL)RIMANTADINE HYDROCHLORIDE TABLETS, 100 MGprescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2014-07-171000636293552
448842cd7-2d78-455a-a688-b148347b6dd5 (view SPL)RIMANTADINE HYDROCHLORIDE TABLETS, 100 MGprescriptionHuman PrescriptionH.J. Harkins Company, Inc.MANUFACTURE, REPACK2011-09-121529590305
549f7d69a-820b-4c75-a31d-b2104c019c12 (view SPL)RIMANTADINE HYDROCHLORIDE TABLETS, 100 MGprescriptionHuman PrescriptionGlobal PharmaceuticalsMANUFACTURE, REPACK2010-05-173001151911
6a1d00c0f-ec9d-4849-b3b5-9c0dff07026c (view SPL)RIMANTADINE HYDROCHLORIDE TABLETS, 100 MGprescriptionHuman PrescriptionCarilion Materials ManagementREPACK2010-05-172681512103

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