Amantadine Oral Capsule

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Sandoz Inc (2013-08-08)
Oldest Current Product
1987-02-18
License(s)
ANDA
RxNORM
ORAL CAPSULE\AMANTADINE
FDAOB
ORAL\CAPSULE\AMANTADINE HYDROCHLORIDE
SPL Active
ORAL\CAPSULE, GELATIN COATED\AMANTADINE HYDROCHLORIDE
ORAL\CAPSULE, LIQUID FILLED\AMANTADINE HYDROCHLORIDE
ORAL\CAPSULE\AMANTADINE HYDROCHLORIDE
SPL Moiety
ORAL\CAPSULE, GELATIN COATED\AMANTADINE
ORAL\CAPSULE, LIQUID FILLED\AMANTADINE
ORAL\CAPSULE\AMANTADINE

product(s) by strength(s)

amantadine hydrochloride 100 mg oral capsule

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1007812048ANDASandoz Inc1987-02-18AMANTADINE HYDROCHLORIDEORALCAPSULEANDA0712934fb81272-194b-476e-a5a9-ea5c1d31c69f
2008321015ANDAUpsher-Smith Laboratories, Inc.2011-09-15AMANTADINE HYDROCHLORIDEORALCAPSULE, GELATIN COATEDANDA0705895232b933-1df9-43b4-8ac2-61bfa4855e68
3008322012ANDAUpsher-Smith Laboratories, Inc.1987-02-18AMANTADINE HYDROCHLORIDEORALCAPSULEANDA071293062b646c-5ad9-4836-9e47-8678e1f2da7e
4108885006ANDABanner Pharmacaps2012-11-01AMANTADINE HYDROCHLORIDEORALCAPSULE, LIQUID FILLEDANDA07872087db36f3-c831-4a84-a3c5-e9d6cc7191af
5693870100ANDABanner Life Sciences Llc.2015-09-07AMANTADINE HYDROCHLORIDEORALCAPSULE, LIQUID FILLEDANDA078720d6e6e111-38da-43a2-b6c4-15e69b720495

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1005271704ANDALannett Company, Inc.2008-11-01AMANTADINE HYDROCHLORIDEORALCAPSULE108887118ANDA07872017f205dd-0feb-4c49-a0e1-2d0c362c6bd7
2006150326ANDANcs Healthcare Of Ky, Inc Dba Vangard Labs1987-02-18AMANTADINE HYDROCHLORIDEORALCAPSULE007812048ANDA071293070d3275-4b91-441f-a4e6-5a67b7d768a5
3165900008ANDAStat Rx Usa Llc1987-02-18AMANTADINE HYDROCHLORIDEORALCAPSULE007812048ANDA071293c40ecd11-0b6e-4f13-bfba-8f011c60ca16
4216950564ANDARebel Distributors Corp2008-11-01AMANTADINE HYDROCHLORIDEORALCAPSULE005271704ANDA078720c74c9424-278d-4a52-8866-db66f6c3ac67
5332610773ANDAAidarex Pharmaceuticals Llc1987-02-18AMANTADINE HYDROCHLORIDEORALCAPSULE007812048ANDA0712930637f133-1f9d-48b3-b82f-a4e16f926cd6
6422910125ANDAAvkare, Inc.2013-08-07AMANTADINE HYDROCHLORIDEORALCAPSULE, LIQUID FILLED693870100ANDA078720bfd129ae-8b0a-f118-b7d0-45d106290b63
7433530947ANDAAphena Pharma Solutions - Tennessee, Llc1987-02-18AMANTADINE HYDROCHLORIDEORALCAPSULE007812048ANDA07129399351f6a-82d7-4d3b-a214-e48260a63d05
8493490193ANDARemedyrepack Inc.2011-04-20AMANTADINE HYDROCHLORIDEORALCAPSULE005271704ANDA0787206dfef8f0-69cf-4a65-8f9b-bc9359926d1c
9499990324ANDALake Erie Medical Dba Quality Care Products Llc1987-02-18AMANTADINE HYDROCHLORIDEORALCAPSULE007812048ANDA071293ce3e1ae0-17f4-4fa3-9d9c-4239c54ae6ea
10500900020ANDAA-S Medication Solutions Llc1987-02-18AMANTADINE HYDROCHLORIDEORALCAPSULE007812048ANDA071293da693bb0-0cc8-485d-89a7-c8cf28d440f3
11502680069ANDAAvpak2014-03-28AMANTADINE HYDROCHLORIDEORALCAPSULE, LIQUID FILLED693870100ANDA078720461e6444-189e-62ed-6c61-1c36a04459c6
12510790247ANDAMylan Institutional Inc.2012-12-28AMANTADINE HYDROCHLORIDEORALCAPSULE007812048ANDA071293fc78c074-3ca8-4e29-9c18-8fab97558fc2
13538080933ANDAState Of Florida Doh Central Pharmacy2014-01-01AMANTADINE HYDROCHLORIDEORALCAPSULE, LIQUID FILLED108885006ANDA078720e3ea1dbc-47cc-462d-a360-a3944f80b14c
14545690084ANDAA-S Medication Solutions Llc1987-02-18AMANTADINE HYDROCHLORIDEORALCAPSULE007812048ANDA07129315b8c51d-e066-49bf-8302-6ddfc2702ba6
15548680800ANDAPhysicians Total Care, Inc.1993-01-06AMANTADINE HYDROCHLORIDEORALCAPSULE007812048ANDA07129333a3e25d-80fa-479f-a419-d9487281deff
16552890012ANDAPd-Rx Pharmaceuticals, Inc.2011-09-15AMANTADINE HYDROCHLORIDEORALCAPSULE, GELATIN COATED008321015ANDA070589944ab74b-2657-4821-9f2a-e695b5f24d97
17636292681ANDABryant Ranch Prepack2008-11-01AMANTADINE HYDROCHLORIDEORALCAPSULE005271704ANDA078720a2caed21-e9a3-228e-70a8-de30a1b368be
18680840611ANDAAmerican Health Packaging2013-02-14AMANTADINE HYDROCHLORIDEORALCAPSULE007812048ANDA071293baec41e5-d898-4fff-8261-de39f23bcb1e
19681512991ANDACarilion Materials Management1987-02-18AMANTADINE HYDROCHLORIDEORALCAPSULE007812048ANDA071293076740b2-9a76-45e9-9d56-87e9f3b96e97
20687889530ANDAPreferred Pharmaceuticals, Inc.2013-12-20AMANTADINE HYDROCHLORIDEORALCAPSULE, LIQUID FILLED108885006ANDA07872013602c1d-d1c9-496b-baa6-8dee92519d67

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA070589AMANTADINE HYDROCHLORIDEUSL PHARMA INC1986-08-05ANDA070589_001
2ANDA071000SYMADINETrueSOLVAY PHARMACEUTICALS1986-09-04ANDA071000_001
3ANDA071293AMANTADINE HYDROCHLORIDESANDOZ INC1987-02-18ANDA071293_001
4ANDA071382AMANTADINE HYDROCHLORIDETrueWATSON LABORATORIES INC1987-01-21ANDA071382_001
5ANDA077659AMANTADINE HYDROCHLORIDETrueACTAVIS ELIZABETH LLC2006-02-23ANDA077659_001
6ANDA078720AMANTADINE HYDROCHLORIDEBANNER LIFE SCIENCES LLC2008-05-29ANDA078720_001
7NDA016020SYMMETRELTrueENDO PHARMACEUTICALS INCNDA016020_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA070589_001RXAMANTADINE HYDROCHLORIDE (100MG)ORALCAPSULEFalseAB1986-08-05AMANTADINE HYDROCHLORIDE
2ANDA071000_001discontinuedAMANTADINE HYDROCHLORIDE (100MG)ORALCAPSULEFalse1986-09-04SYMADINE
3ANDA071293_001RXAMANTADINE HYDROCHLORIDE (100MG)ORALCAPSULETrueAB1987-02-18AMANTADINE HYDROCHLORIDE
4ANDA071382_001discontinuedAMANTADINE HYDROCHLORIDE (100MG)ORALCAPSULEFalse1987-01-21AMANTADINE HYDROCHLORIDE
5ANDA077659_001discontinuedAMANTADINE HYDROCHLORIDE (100MG)ORALCAPSULEFalse2006-02-23AMANTADINE HYDROCHLORIDE
6ANDA078720_001RXAMANTADINE HYDROCHLORIDE (100MG)ORALCAPSULEFalseAB2008-05-29AMANTADINE HYDROCHLORIDE
7NDA016020_001discontinuedAMANTADINE HYDROCHLORIDE (100MG)ORALCAPSULEFalseSYMMETREL

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1062b646c-5ad9-4836-9e47-8678e1f2da7e (view SPL)Amantadine Hydrochloride Capsules, USPprescriptionHuman PrescriptionUpsher-Smith Laboratories, Inc.2011-10-1710008322012
20637f133-1f9d-48b3-b82f-a4e16f926cd6 (view SPL)Amantadine Hydrochloride Capsules, USPprescriptionHuman PrescriptionAidarex Pharmaceuticals Llc2013-11-151332610773
3070d3275-4b91-441f-a4e6-5a67b7d768a5 (view SPL)Amantadine Hydrochloride Capsules, USPprescriptionHuman PrescriptionNcs Healthcare Of Ky, Inc Dba Vangard LabsRELABEL, REPACK2012-03-191006150326
4076740b2-9a76-45e9-9d56-87e9f3b96e97 (view SPL)Amantadine Hydrochloride Capsules, USPprescriptionHuman PrescriptionCarilion Materials ManagementREPACK2013-08-082681512991
513602c1d-d1c9-496b-baa6-8dee92519d67 (view SPL)Amantadine Hydrochloride Capsules, USP Rx onlyprescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.REPACK2013-12-241687889530
615b8c51d-e066-49bf-8302-6ddfc2702ba6 (view SPL)Amantadine Hydrochloride Capsules, USPprescriptionHuman PrescriptionA-S Medication Solutions Llcrepack2013-06-171545690084
717f205dd-0feb-4c49-a0e1-2d0c362c6bd7 (view SPL)Amantadine Hydrochloride Capsules, USPRx OnlyprescriptionHuman PrescriptionLannett Company, Inc.ANALYSIS, MANUFACTURE, PACK2011-06-1312005271704
833a3e25d-80fa-479f-a419-d9487281deff (view SPL)Amantadine Hydrochloride Capsules, USPprescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2014-01-175548680800
9461e6444-189e-62ed-6c61-1c36a04459c6 (view SPL)Amantadine Hydrochloride Capsules, USP Rx onlyprescriptionHuman PrescriptionAvpak2015-10-073502680069
104fb81272-194b-476e-a5a9-ea5c1d31c69f (view SPL)Amantadine Hydrochloride Capsules, USPprescriptionHuman PrescriptionSandoz Inc2013-08-0812007812048
115232b933-1df9-43b4-8ac2-61bfa4855e68 (view SPL)AMANTADINE HYDROCHLORIDE CAPSULES, USPprescriptionHuman PrescriptionUpsher-Smith Laboratories, Inc.2012-11-1512008321015
126dfef8f0-69cf-4a65-8f9b-bc9359926d1c (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2011-04-202493490193
1387db36f3-c831-4a84-a3c5-e9d6cc7191af (view SPL)Amantadine Hydrochloride Capsules, USP Rx onlyprescriptionHuman PrescriptionBanner PharmacapsANALYSIS, MANUFACTURE2012-07-125108885006
14944ab74b-2657-4821-9f2a-e695b5f24d97 (view SPL)AMANTADINE HYDROCHLORIDE CAPSULES, USPprescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2011-11-2011552890012
1599351f6a-82d7-4d3b-a214-e48260a63d05 (view SPL)Amantadine Hydrochloride Capsules, USPprescriptionHuman PrescriptionAphena Pharma Solutions - Tennessee, LlcRepack2014-06-101433530947
16a2caed21-e9a3-228e-70a8-de30a1b368be (view SPL)AMANTADINE HCLprescriptionHuman PrescriptionBryant Ranch PrepackANALYSIS, MANUFACTURE, RELABEL, REPACK2012-10-123636292681
17baec41e5-d898-4fff-8261-de39f23bcb1e (view SPL)Amantadine Hydrochloride Capsules, USPprescriptionHuman PrescriptionAmerican Health PackagingREPACK2014-01-092680840611
18bfd129ae-8b0a-f118-b7d0-45d106290b63 (view SPL)Amantadine Hydrochloride Capsules, USPRx onlyprescriptionHuman PrescriptionAvkare, Inc.2015-09-302422910125
19c40ecd11-0b6e-4f13-bfba-8f011c60ca16 (view SPL)Amantadine Hydrochloride Capsules, USPprescriptionHuman PrescriptionStat Rx Usa Llcrelabel, repack2010-09-161165900008
20c74c9424-278d-4a52-8866-db66f6c3ac67 (view SPL)prescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2010-09-021216950564
21ce3e1ae0-17f4-4fa3-9d9c-4239c54ae6ea (view SPL)Amantadine Hydrochloride Capsules, USPprescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcrepack2012-11-301499990324
22d6e6e111-38da-43a2-b6c4-15e69b720495 (view SPL)Amantadine Hydrochloride Capsules, USP Rx onlyprescriptionHuman PrescriptionBanner Life Sciences Llc.ANALYSIS, MANUFACTURE2015-09-082693870100
23da693bb0-0cc8-485d-89a7-c8cf28d440f3 (view SPL)Amantadine Hydrochloride Capsules, USPprescriptionHuman PrescriptionA-S Medication Solutions Llcrepack2015-02-151500900020
24e3ea1dbc-47cc-462d-a360-a3944f80b14c (view SPL)Amantadine Hydrochloride Capsules, USP Rx onlyprescriptionHuman PrescriptionState Of Florida Doh Central Pharmacyrepack2014-02-261538080933
25fc78c074-3ca8-4e29-9c18-8fab97558fc2 (view SPL)Amantadine Hydrochloride Capsules, USPprescriptionHuman PrescriptionMylan Institutional Inc.2012-12-072510790247

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