Minoxidil Oral Tablet

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Watson Laboratories, Inc. (2010-07-26)
Oldest Current Product
1988-11-14
License(s)
ANDA
RxNORM
ORAL TABLET\MINOXIDIL
FDAOB
ORAL\TABLET\MINOXIDIL
SPL Active
ORAL\TABLET\MINOXIDIL
SPL Moiety
ORAL\TABLET\MINOXIDIL

product(s) by strength(s)

minoxidil 10 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005915643ANDAWatson Laboratories, Inc.2009-10-26MINOXIDILORALTABLETANDA071345ab30461c-f8c8-409d-9e24-d58ed8a34873
2498840257ANDAPar Pharmaceutical Companies, Inc.1988-11-14MINOXIDILORALTABLETANDA0718398f3800f0-b6da-4dfe-8c32-39bb5eb0262a
3534890387ANDAMutual Pharmaceutical Company, Inc.1995-12-14MINOXIDILORALTABLETANDA0727090354a7f5-5917-44dc-9963-411104008cb5

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1422910619ANDAAvkare, Inc.2013-08-01MINOXIDILORALTABLET534890387ANDA07270902d7399f-94cc-f718-f214-587301edd138
2521250039ANDARemedyrepack Inc.2013-02-26MINOXIDILORALTABLET498840257ANDA071839da4c68cf-e25f-45a7-a749-0b987ec2ba96
3521250170ANDARemedyrepack Inc.2013-03-20MINOXIDILORALTABLET534890387ANDA0727097dee5448-515c-4152-8c6b-7571f6068bd2
4538080733ANDAState Of Florida Doh Central Pharmacy2009-07-01MINOXIDILORALTABLET534890387ANDA072709abeeb857-8303-487a-83fc-de7396c6ea8b
5538081032ANDAState Of Florida Doh Central Pharmacy2014-11-01MINOXIDILORALTABLET498840257ANDA071839a167ba5d-b01a-4142-910f-f3314159e852
6545691983ANDAA-S Medication Solutions Llc1988-11-14MINOXIDILORALTABLET498840257ANDA0718390697e266-f8ab-4ccf-9d84-cc230e7a913a
7548683467ANDAPhysicians Total Care, Inc.1996-09-13MINOXIDILORALTABLET005915643ANDA07134556274d6f-8439-4ab7-9bb8-a3fc10a26463
8680840205ANDAAmerican Health Packaging2007-07-30MINOXIDILORALTABLET498840257ANDA0718390b4fc036-9497-442b-b629-c4b386932789

minoxidil 2.5 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005915642ANDAWatson Laboratories, Inc.2009-10-26MINOXIDILORALTABLETANDA071344ab30461c-f8c8-409d-9e24-d58ed8a34873
2498840256ANDAPar Pharmaceutical Companies, Inc.1988-11-14MINOXIDILORALTABLETANDA0718268f3800f0-b6da-4dfe-8c32-39bb5eb0262a
3534890386ANDAMutual Pharmaceutical Company, Inc.1995-12-14MINOXIDILORALTABLETANDA0727090354a7f5-5917-44dc-9963-411104008cb5

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1006157593ANDANcs Healthcare Of Ky, Inc Dba Vangard Labs1988-11-14MINOXIDILORALTABLET498840256ANDA071826d7f4088e-e99a-4e3e-aea4-2c7834abe7b5
2422910618ANDAAvkare, Inc.2013-08-01MINOXIDILORALTABLET534890386ANDA07270802d7399f-94cc-f718-f214-587301edd138
3493490654ANDARemedyrepack Inc.2011-05-18MINOXIDILORALTABLET498840256ANDA0718260e830772-b1d7-4608-972e-b98cdf06327e
4538080734ANDAState Of Florida Doh Central Pharmacy2009-07-01MINOXIDILORALTABLET534890386ANDA072709abeeb857-8303-487a-83fc-de7396c6ea8b
5548683465ANDAPhysicians Total Care, Inc.2002-10-16MINOXIDILORALTABLET005915642ANDA07134456274d6f-8439-4ab7-9bb8-a3fc10a26463
6551544777ANDACardinal Health2007-07-30MINOXIDILORALTABLET680840204ANDA07182696592d7b-6201-4add-b99d-b42a13f8bd95
7680840204ANDAAmerican Health Packaging2007-07-30MINOXIDILORALTABLET498840256ANDA0718260b4fc036-9497-442b-b629-c4b386932789

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA071344MINOXIDILWATSON LABORATORIES INC1987-03-03ANDA071344_001
2ANDA071345MINOXIDILWATSON LABORATORIES INC1987-03-03ANDA071345_001
3ANDA071534MINODYLTrueQUANTUM PHARMICS LTD1987-03-19ANDA071534_001
4ANDA071537MINOXIDILTrueUSL PHARMA INC1988-12-16ANDA071537_001
5ANDA071796MINOXIDILTrueROYCE LABORATORIES INC1987-11-10ANDA071796_001
6ANDA071799MINOXIDILTrueROYCE LABORATORIES INC1987-11-10ANDA071799_001
7ANDA071826MINOXIDILPAR PHARMACEUTICAL INC1988-11-14ANDA071826_001
8ANDA071839MINOXIDILPAR PHARMACEUTICAL INC1988-11-14ANDA071839_001
9ANDA072153MINODYLTrueQUANTUM PHARMICS LTD1988-07-13ANDA072153_001
10ANDA072708MINOXIDILMUTUAL PHARMACEUTICAL CO INC1995-12-14ANDA072708_001
11ANDA072709MINOXIDILMUTUAL PHARMACEUTICAL CO INC1995-12-14ANDA072709_001
12NDA018154LONITENTruePHARMACIA AND UPJOHN CONDA018154_001, NDA018154_003

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA071344_001RXMINOXIDIL (2.5MG)ORALTABLETFalseAB1987-03-03MINOXIDIL
2ANDA071345_001RXMINOXIDIL (10MG)ORALTABLETTrueAB1987-03-03MINOXIDIL
3ANDA071534_001discontinuedMINOXIDIL (10MG)ORALTABLETFalse1987-03-19MINODYL
4ANDA071537_001discontinuedMINOXIDIL (2.5MG)ORALTABLETFalse1988-12-16MINOXIDIL
5ANDA071796_001discontinuedMINOXIDIL (10MG)ORALTABLETFalse1987-11-10MINOXIDIL
6ANDA071799_001discontinuedMINOXIDIL (2.5MG)ORALTABLETFalse1987-11-10MINOXIDIL
7ANDA071826_001RXMINOXIDIL (2.5MG)ORALTABLETFalseAB1988-11-14MINOXIDIL
8ANDA071839_001RXMINOXIDIL (10MG)ORALTABLETFalseAB1988-11-14MINOXIDIL
9ANDA072153_001discontinuedMINOXIDIL (2.5MG)ORALTABLETFalse1988-07-13MINODYL
10ANDA072708_001RXMINOXIDIL (2.5MG)ORALTABLETFalseAB1995-12-14MINOXIDIL
11ANDA072709_001RXMINOXIDIL (10MG)ORALTABLETFalseAB1995-12-14MINOXIDIL
12NDA018154_001discontinuedMINOXIDIL (2.5MG)ORALTABLETFalseLONITEN
13NDA018154_003discontinuedMINOXIDIL (10MG)ORALTABLETFalseLONITEN

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
102d7399f-94cc-f718-f214-587301edd138 (view SPL)MINOXIDIL TABLETS USPprescriptionHuman PrescriptionAvkare, Inc.2014-07-172422910618, 422910619
20354a7f5-5917-44dc-9963-411104008cb5 (view SPL)MINOXIDIL TABLETS USPprescriptionHuman PrescriptionMutual Pharmaceutical Company, Inc.2015-01-083534890386, 534890387
30697e266-f8ab-4ccf-9d84-cc230e7a913a (view SPL)prescriptionHuman PrescriptionA-S Medication Solutions Llcrelabel2013-10-061545691983
40b4fc036-9497-442b-b629-c4b386932789 (view SPL)MINOXIDIL TABLETS, USPprescriptionHuman PrescriptionAmerican Health PackagingREPACK2015-10-093680840204, 680840205
50e830772-b1d7-4608-972e-b98cdf06327e (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2011-05-182493490654
656274d6f-8439-4ab7-9bb8-a3fc10a26463 (view SPL)MinoxidilTablets USPRevised: June 2009Rx only190799prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2012-03-042548683465, 548683467
77dee5448-515c-4152-8c6b-7571f6068bd2 (view SPL)MINOXIDIL TABLETS USPprescriptionHuman PrescriptionRemedyrepack Inc.2013-03-201521250170
88f3800f0-b6da-4dfe-8c32-39bb5eb0262a (view SPL)prescriptionHuman PrescriptionPar Pharmaceutical Companies, Inc.MANUFACTURE2015-03-126498840256, 498840257
996592d7b-6201-4add-b99d-b42a13f8bd95 (view SPL)Minoxidil Tablets, USPprescriptionHuman PrescriptionCardinal HealthREPACK2015-04-234551544777
10a167ba5d-b01a-4142-910f-f3314159e852 (view SPL)prescriptionHuman PrescriptionState Of Florida Doh Central Pharmacyrepack2015-01-101538081032
11ab30461c-f8c8-409d-9e24-d58ed8a34873 (view SPL)MinoxidilTablets USPRevised: June 2009Rx only190799prescriptionHuman PrescriptionWatson Laboratories, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2010-07-262005915642, 005915643
12abeeb857-8303-487a-83fc-de7396c6ea8b (view SPL)MINOXIDIL TABLETS USPprescriptionHuman PrescriptionState Of Florida Doh Central Pharmacyrepack2010-06-071538080733, 538080734
13d7f4088e-e99a-4e3e-aea4-2c7834abe7b5 (view SPL)MinoxidilprescriptionHuman PrescriptionNcs Healthcare Of Ky, Inc Dba Vangard LabsRELABEL, REPACK2010-06-021006157593
14da4c68cf-e25f-45a7-a749-0b987ec2ba96 (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2013-02-261521250039

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